Efficacy of Badarodakadi Asthapana Basti followed by Madhuraushadhi siddha tail Anuvasana Basti with Yonipichu for Sukhaprasava – A Clinical Trial.

RESEARCH QUESTION

What is the effect of Badarodakadi Asthapana Basti followed by Madhuraushadhi Siddha Tail Anuvasana Basti with Yoni Pichu for Sukhaprasava*.*

HYPOTHESIS

Badarodakadi Asthapana Basti followed by Madhuraushadhi Siddha Tail Anuvasana Basti with Yoni Pichu have a significant effect for Sukhaprasava

NULL HYPOTHESIS (H0)

There is no effect of Badarodakadi Asthapana Basti followed by Madhuraushadhi Siddha Tail Anuvasana Basti with Yoni Pichu for Sukhaprasava .

ALTERNATIVE HYPOTHESIS (H1)

There is significant effect of Badarodakadi Asthapana Basti followed by Madhuraushadhi Siddha Tail Anuvasana Basti with Yoni Pichu for Sukhaprasava**.**

INTRODUCTION:

In a woman’s life, motherhood is a crowning act. Every woman tries to enter in this new world of mother with minimum pain, operative aids and complications. As child bearing and delivery are physiological phenomenon and any abnormality in courses of labour can affect women health not only for that time being but also through out her life. That’s why Acharya have given specific importance to the Garbhini and compared her with the pot filled with oil, as slightest oscillation of such pot causes spilling of oil, similarly slightest excitement to the pregnant women can initiate pathological state. Acharya Kashyapa also stated that during Prasava avastha, “Her one foot is in the house of ‘Yama’ (the god of death) and other on this side (i.e., she can die at any moment).

Ensuring healthy and safe motherhood with foremost care to every pregnant woman is the outright responsibility of an obstetrician. So, to provide proper attention during pregnancy and delivery the concept of ante natal care as Garbhini paricharya is very explicitly described in ancient literatures which promote easy parturition and healthy progeny. That’s why for good health of mother and baby*, Sukhprasava* is important. The word Sukhprasava means bringing (or having brought) forth easily or happily.

The term ‘prakrit  prasav ’ includes:

Swabhavh  -  spontaneous onset

Upasthith kala - at term

Avaksira  -  cephalic  presentation

Swabhawik kal - without undue prolongation

So at the onset of labour  the  foetus  gets  turned  &  comes  forward  due  to the  action of  prasooti marutand  then  is  expelled  out  through  apathyapath  this  is  termed  as  normal labour.As  per  Ayurveda  the  ‘Apaan  vayu’  plays  an  important  role along with ‘Vyana vayu’ in act of contraction and relaxation of uterus and in expulsion of foetus*. Vyana  vayu*  is  essential  for  contraction  &  relaxation  of  myometrium  and  due to its effect apana vayu becomes active to expel the Garbha outside the garbhashaya.  To  keep  this  vayu  in  balanced  state,  Acharyas  have  advised  the administration of Asthapana basti,  Anuvasan  basti,  Pichu .  Vayu  is  most  likely  to  be vitiated  during  pregnancy,  and  it  is  described  that  there  is  no  other  remedy  more beneficial  than  administration  of  ‘Basti’  particularly  in  affliction  of  vayu as basti is considered as the paramoushadhi of vata.

Need of the Study

•       The  incidence  of  cesarean  section  is steadily rising (As per National Family Health survey NFHS the trend of c section deliveries in India has been on rise i.e.21.5 percent in 2019-21) because of increased safety of the operation due to improved anaesthesia, availability of blood transfusion and antibiotics, also its a painless mode of delivery .

•       Normal delivery is generally preferred over cesarean  section because  it can lead to a quicker recovery for the mother, reduced risk of infection, and fewer complications.

•        So to ensure  maternal  and  fetal  wellbeing and  to  bring  about  normal  vaginal  delivery and to reduce complications due to C-sections  Asthapan basti  followed by Anuvasana  basti   and  Yoni pichu  can  play  an  important  role  in  normalizing  the  Apan vayuat  the  time  of  child  birth and  provide  a  safe passage  to  the  passenger.

This study aims to highlight the fact that the   principles  and  formulations  regarding  striroga and  prasuti  tantra  mentioned  in  Ayurvedic  texts  stand  invulnerable  in  this  present  era  and their  importance  cannot  be  neglected

REVIEW OF LITERATURE:

CLASSICAL REVIEW**:**

" In 8th month of pregnancy due to hormonal effect and Kapha Vata prakopa backache, constipation are very common problems. So Acharyas have mentioned Anuvasan and Aasthapan Basti in 8th month in Garbhini paricharya containing drugs mainly Kapha and Vata shamak. This Basti regulates Vata and clear the retained feces. Due to movement of vayu in its right direction, it delivers the baby without difficulty and remains free from complications.

According to Sushruta -

**Aasthapan Basti:**3 Decoction of badar is mixed with bala, atibala, shatpushpa, palala, milk, curd, oil, salt, madanphala, honey and ghrita.

Anuvasan Basti: Oil medicated with milk and decoction of madhur group drugs are mentioned in Anuvasan Basti.

Yonipichu  (vaginal tampon):  Yonipichu  is the application of  sterile swab soaked in medicated oil or decoction into the vagina.

DRUG REVIEW

Sr no

Latin name

Rasa

Guna

Virya

Vipaka

Karma

Parts used

Quantity

|Badar

Zizyphus jujube

Lamk.

Amla, madhur,kashaya

Snigdha, guru,

sheet

Madhur

vata pitta nashakVatanulomana, malabhedana

Fal majja

200g

|Shatpushpa

Anethum sowa

Kurz

Umbelliferae

Katu, ushna, laghu, ruksha, tikshna

Ushna

Madhur

Vatanulomana, vedanasthapana

Seeds

10g

|Bala

Sida cordifolia Linn

Malvaceae

Snigdha,Guru,Picchila

sheet

Madhur

Balya, vryshya, vatapitta hara,

Roots

10g

|Atibala

Abutilon indicum Linn

Malvaceae

Guru,Snigdha,Picchila

Sheet

Madhur

Vatahara, beej snehana,

mruduvirechaka, vedanahara, balya

Roots

10g

|dugdha

milk

madhur

Mrudu ,snigdha ,guru

sheet

madhur

Balya ,ojavridhhi

 16ml

|Palal

       16ml

|Ghrit

 madhur

 sheet

madhur

Agni,virya,oja vardhak,vatapittashamak

 16ml

|Dadhi

curd

Madhur ,amla,kashaya

Snigdha,guru

ushna

amla

Snehan,vatanashak,balvardhak

 16ml

|Mastu

Liquid part of curd

Amla ,kashaya madhur

Laghu,rukshya

sheet

 Vatakaphashamak,srotovishodhaka

 16ml

|taila

Sesame oil

Madhur,kashaya

Sukshma,vyavayi,

Ushna

 Vatanashak,balya

 80ml

|Lavan

Salt

Madhur

Sukshma ,laghu

Sheet

Madhur

Tridoshnahak

 5g

|Madanphala

Randia spinosa

 Kashaya,katu,tikta,madhur

Laghu ,ruksha

Ushna

Katu

Kaphavatahara

Seeds

10g

|Madhu

honey

Kashaya,madhur

Guru,sheet,ruksha

Sheet

Madhur

Kaphanashak,chhedak

  80g

Ingredients of madhuraushadh siddha tail -

No

Drug

Latin name

Family

Proportion

Part used

|1

Guduchi

Tinospora cordifolia( Willed.Miers*)*

Meninspermaceae

1 part

Stem

|2

Ashwagandha

Withania somnifera Dunal

Solanaceae

1part

Root

|3

bala

Sida cordifolia Linn

Malvaceae

1part

Root

|4

Atibala

Abutilon indicum Linn

Malvaceae

1part

Root

|5

Yashtimadhu

Glycerrhiza glabra Linn

Leguminoceae

1part

Root

|6

Tilataila

Sesamum indicum

pedaliaceae

16 parts

No

Drug

rasa

guna

virya

vipaka

Karya

|1

Guduchi

Kashaya ,tikta

Laghu  ,snigdha

Ushna

Madhur

Tridoshhara ,balya

|2

Ashwagandha

Madhur

Guru, snigdha

Ushna

Madhur

Balya

|3

Bala

Madhur

Guru ,snigdha,pichhil

Sheet

Madhur

Vatapittashamak ,antiinflamatory

|4

Yashtimadhu

Madhur

Guru ,snigdha

Sheet

Madhur

Vatashaman ,antiinflamatory

|5

Tiltaila

Madhur ,kashaya

Sukshma ,vyavayi

Ushna

 Vatanashaka ,balya

|6

Atibala

Madhura

Laghu ,snigdha

Sheet

Madhur

Balya ,brihan,vatapittashaman

MODERN REVIEW

NORMAL LABOUR :

Series of events that take place in the genital organs in an effort to expel the viable products of conception (fetus, placenta and the membranes) out of the womb through the vagina into the outer world is called Labor.

It may occur prior to 37 completed weeks, when it is called the preterm labor.

CRITERIA OF NORMAL LABOR (EUTOCIA):

Labor is called normal if it fulfills the following criterias.

(1) Spontaneous in onset and at term.

(2) With vertex presentation.

(3) Without undue prolongation.

(4) Natural termination with minimal aids.

(5) Without having any complications affecting the health of the mother and/or the baby.

 CAUSES OF ONSET OF LABOR

The precise mechanism of initiation of human labor is still obscure. Endocrine, biochemical and mechanical stretch pathways as obtained from animal experiments,

however, put forth the following hypotheses.

1.Uterine distension: Stretching effect on the myometrium by the growing fetus and liquor amnii can explain the onset of labor at least in twins or polyhydramnios.

 2. Fetoplacental contribution: Cascade of events activate fetal hypothalamic-pituitary-adrenal axis prior to onset of labor �’ increased CRH �’ increased release of ACTH �’ fetal adrenals �’ increased cortisol secretion �’ accelerated production of estrogen and prostaglandins from the placenta.

 3. Estrogen:  Increases the release of oxytocin from maternal pituitary.

— Promotes the synthesis of myometrial receptors for oxytocin and prostaglandins.

— Increases the excitability of the myometrial cell membranes.

4. Progesterone: Cortisol inhibits the conversion of fetal pregnenolone to progesterone. Progesterone levels therefore fall before labor. It is the alteration in the

estrogen : progesterone ratio.

 5.Prostaglandins: Prostaglandins are the important factors, which initiate and maintain labor. The major sites of synthesis of prostaglandins are—amnion,

chorion, decidual cells and myometrium.Synthesis is triggered by—rise in estrogen level,glucocorticoids, mechanical stretching in late pregnancy, increase in cytokines (IL–1, 6, TNF),infection, vaginal examination, and separation or rupture of the membranes.

 6. Oxytocin and myometrial oxytocin receptors: (i) Large number of oxytocin receptors are present in the fundus compared to the lower segment and the

cervix. (ii) Receptor number  and senitivity increases during pregnancy reaching maximum during labor. (iii) Oxytocin stimulate synthesis and release of PGs (E2 and F2α) from amnion and decidua. Vaginal examination and amniotomy cause rise in maternal plasma oxytocin level

(Ferguson reflex). Fetal plasma oxytocin level is found increased during spontaneous labor compared to that of mother. Its role in human labor is not yet established.

 STAGES OF LABOR - Conventionally, events of labor are divided into three stages:

1.First stage:

It starts from the onset of true labor pain and ends with full dilatation of the cervix. It is, in other words, the “cervical stage” of labor. Its average duration is 12 hours in primigravidae and 6 hours in multiparae.

2.Second stage:

It starts from the full dilatation of the cervix (not from the rupture of the membranes) and ends with expulsion of the fetus from the birth canal. It has got two phases—

3.Third stage:

It begins after expulsion of the fetus and ends with expulsion of the placenta and membranes(afterbirths). Its average duration is about 15 minutes in

both primigravidae and multiparae.

4.Fourth stage:

It is the stage of observation for at least1 hour after expulsion of the afterbirths. During thisperiod maternal vitals, uterine retraction and any vaginal

bleeding are monitored. Baby is examined.

 MECHANISM OF NORMAL LABOR

DEFINITION: The series of movements that occur on the head in the process of adaptation during its journey through the pelvis is called mechanism of labor.

MECHANISM: In normal labor, the principal movements are:

(1) engagement,

(2) descent,

(3) flexion,

(4) internal rotation,

(5) crowning,

(6) extension,

(7) restitution,

(8) external rotation, and

(9) expulsion of the trunk.

 PREVIOUS WORK DONE

S No

Institution

Author

Year

Title

|1

Deptt.of  Prasuti and  Stri Roga  Veena  Vadini Ayurvedic  College Bhopal

Meenakshi pal

2016

Role  of anuvasanvasti with pichu & sukh prasavkar yoga in  pregnancy on progress of labour

|2

ASS  College  Nashik

Jadhav    Archana

2017

Study  of  efficacy  of  bala  siddha  taila    pitchu   on  cervical  ripening  and  effacement

|3

Department of P.T.S.R, J.G.Cop. Society Ayurvedic medical college, Ghataprabha.

Dr Verma Neha

2018

Role of kadamba masha taila anuvasana vasti in the ninth month of pregnancy for sukhaprasava

|4

National Institute of Ayurveda ,Jaipur

Dr Priyanka Hajare

2020

Sukhaprasava (Normal labour) in ancient literature:A review

|5

Lecturer shri Jayendra Sarswati Ayurveda college Nazaraphet Chennai and former professor head of prasuti tantra and dean of IMS BHU Varanasi

K.Prameela devi and P.V.Tiwari

2005

Comparative study of Baladi taila and Tila taila pichu in the management of Prasava

|6

Bidar

Baswade J et al

2011

Matra basti with Yoni pichu with Bala tail

|7

Hadapsar

Gawade T. et al

2015

Anuvasan basti with Balasidhha tail

|8

RGGPGAC Paprola HP

Chandla Anubha et al

2015

Matra basti with yoni pichu with Balyam tail

OUTCOME OF THE CITED STUDIES :

 All the previous trials reported a positive outcome of the Anuvasana basti /or Yoni pichu/Asthapana basti in ninth month or during labour .It promotes normal vaginal delivery with reduction in duration of labour lesser need of induction and augmentation of labour .bishops score was more favourable in patients where vaginal tampon of medicated oil was given.

OBJECTIVES:

 The present research trial has been undertaken with the following objectives

PRIMARY OBJECTIVES:

1.     Assessment  of effect of Badarodakadi Asthapana Basti followed by Madhuraushadhi Siddha Tail Anuvasana Basti and Yoni Pichu  on Sukhaprasava throughbishop’s  score.

SECONDARY OBJECTIVES

1.     Assessment of effect of the given intervention on  APGAR Score of the baby.

.

   METHODOLOGY

STUDY DESIGN

Clinical Trial

|STUDY SITE

Opd ipd of AIIA

|MASKING

Open label

|RESEARCH DESIGN

Interventional study

|SAMPLE SIZE

87

|GROUP

One

|

 | | | --- | |

Screening

screeniscngs                     enennkhdgdijrollmenthh

Enrollment

Allocation (n=87)

Baseline  evaluation (ANC profile)

Administration of Badarokadi Asthapana Basti followed by Madhuraushadhi Sidhha Tail Anuvasana Basti and Yoni Pichu

Evaluation post follow

Data analysis on interpretation

PATIENT SETTING

Patients will be selected from the O.P.D and I.P.D of the Prasuti tantra and Striroga department, All India Institute of Ayurveda, New Delhi, irrespective of occupation and religion. Patients will be selected strictly as per the inclusion criteria given in the Proforma specially designed for the study and recruited into trial after obtaining voluntary consent.

SAMPLE SIZE:

Proposed study is to assess the effect of Badarodakadi asthapana basti with madhuraushadhi siddha anuvasan basti  with pichu .Study aims to promote the occurence of normal vaginal delivery.As per data available in earlier studies , Bishops score was found to be favourable in 78% of cases,assuming it to be 90% in this study with  80% power, 5% level of significance and two sided test, the calculated sample size is 79 in one  group .Assuming 10% drop outs, we will take 87 cases in the study.

SELECTION OF PATIENTS

A written and informed consent will be taken from the patient before the commencement of the treatment. The  study  will be conducted  on  Pregnant  females  fulfilling  all  the  inclusion  &  exclusion criteria  visiting    P.G.  Department  of  Prasuti  and  Striroga  of All India Institute Of Ayurveda ,New delhi.

CRITERIA FOR SELECTION OF PATIENTS

Inclusion  criteria

·       Primigravida of  36-38 weeks of age group between 20-35 years.

·       Normal fetal presentation at term.

·       Normal pelvic measurement (adequate pelvis).

·       Patients willing to give written informed consent

·       ICD-10-CM DIGNOSIS CODE O80 Encounter for full-term uncomplicated delivery.

Exclusion  criteria

·       Patients having  cepholopelvic disproportion, malpresentation, abnormal size of foetus, contracted pelvis.

·       Patients having systemic  diseases like  tuberculosis, jaundice, heart diseases, epilepsy  etc.

·       Patients having  polyhdraminos, pre-eclamsia, eclampsia, and  IUGR.

·       Multiple  pregnancies.

·       Malignancy  of  genital tract.

·       Pelvic  masses causing  obstruction &  vaginal obstruction (adhesion  &  stenosis)

·       Pregnant women  who are  unsuitable for basti treatment ( basti ayogya )

INVESTIGATIONS:

Following investigations will be carried out at All India Institute of Ayurveda,Delhi

Routine Investigations :-

•       Hemogram, Blood Group, RBS, Urine- Routine and Microscopy, Viral Markers, Thyroid Profile, S.Urea,  S.  Creatinine,  LFT,  RFT,  CRP , Coagulation profile.

•       USG (Trimester Wise)

Other  investigations :-

ECG,  2D Echo  will be    advised  in suspected cases to rule out   other  specific diseases .

DRUG PROCUREMENT

SOURCE OF DRUG COLLECTION:

Raw drug will be procured from authentic sources. Identification and quality standardization will be done.

Method of preparation

Asthapan basti - will be prepared as per the classical reference given in the charak samhita.

Madhuraushadh sidhha tail :  In  this  study  5  drugs  guduchi,  ashwagandha  yashtimadhu  bala  atibala   are  selected  from  Madhura Skandha    of  Vimana-Sthana-8.  These  drugs  are  selected  due  to  their  easy  availability & expected  high  degree  of  clinical  effects.  For  Moorchhana  of  Tila  Taila  reference  will be taken  from  Bhasajyaratnavali-Jwararogadhikar  Adhayay.  After  Moorchhana  of  TilaTaila,  Madhura  Aushadha  Sidhha  Taila  will be  prepared  with  Taila  Paka  Vidhi  by  adding these   drugs  to  Moorchhita  Tila  Taila.  The  Taila  will be prepared in pharmacy of All India Institute of Ayurveda New Delhi.

QUALITY CONTROL AND STANDARDIZATION PARAMETERS FOR  MADHURAUSHADH SIDHHA TAIL  :

 

Sr .no.

Tests

|1.

Description

Colour

Odour

|2.

Weight /ml

|3.

Refractive indx at 25 c

|4.

Viscocity

|5.

Iodine value

|6.

Saponification value

|7.

Acid value

|8.

Peroxide value

|9.

Identifications GLC/TLC/HPTLC-with marker wherever available

|10.

Test for heavy metals

Lead,cadmium, mercury,arsenic

|11.

Microbial contamination

Total bacterial count

Total fungal count

|12.

Test for specific pathogen

e.coli, Salmonella spp.,S.aureus,Pseudomonas aeruginosa

|13.

Pesticide residue

Organochlorine pesticides

Organophosphorus pesticides

Pyrethroids

|14.

Test for Aflatoxins (B1,B2,G1,G2)

 INTERVENTION CHART

NAME OF THE DRUG

MODE OF APPLICATION

DOSE

DURATION

|Asthapan basti with badarodak kashaya

Anal route

480ml

1day ( 1st day of 36th week )

|Madhuraushadh sidhha tail anuvasan basti

Madhuraushadh sidhha tail pichu

Anal route

   Vaginal route

 60ml

                              7days  ( will be started from 2nd day of Asthapana basti )

7days ( will be given just after the Anuvasana basti

 " SOP of " Aasthapan basti

BASTI (MEDICATED ENEMA)

Bastikarma is the procedure by which the medicines in suspension form are dministered  through rectum or genitourinary tract using bastiyantra.It is the most appropriate remedial procedure for vatadosha.

Poorvakarma

1. Probable benefits and risks of procedure will be explained to patient.

2.  Patients will be advised to get relieved of their urges of defecation and micturition

3. Anal region will be cleaned with a cotton piece soaked in plain lukewarm water

Pradhankarma :

The  patient is asked to lie on left side drawing up the right leg and straightening of  the left leg.

1. Apply little  quantity of oil on patient’s anus and  nozzle of bastiyantra.

2. The nozzle is gently inserted into the anal canal upto a specific length and bastiputak containing mixture is pressed with uniform pressure.The pressure is continued till only small quantity of fluid remains in the bag.

3. Then the nozzle is removed gently and the patient is allowed to lie down in supine position till he fills urge to excrete.

4. The basti dravya along with faeces normally comes  out  within  10 minutes when  a  full dose of  Niruha basti is given.  The maximum time specified for retention of  bastidravya is  48 minutes. After  evacuation  of  the  bowel,  the patient may take hot water  bath  and  semi  solid diet.  Usually Niruha bastis are  not to be given alone. Wherever required,  Niruha basti must be given  alternatively  with  Snehabasti.

2. SNEHA BASTI (OIL ENEMA):

Administration of medicated oil through anal route is called sneh basti.The dosage from anal route may vary from 60ml to 240ml according to doshika predominance,disease condition/patient’s condition.

Procedure:

Sneha is administered in similar manner as niruha basti.As it is a retension enema,the contents should be allowed to retain inside for a minimum period of three hours .

.

Pashchatkarma :

After the drug has been injected, the waist and foot end should be raised to lift the trunk, in order to facilitate withholding of the drug as long as possible,the buttocks should be patted for maximum retention. Finally, the patient is directed to discharge his urges in Utkataasana (squatting position).

Dose:

·       The dose is to be manipulated according to the contemporary period

·       Niruha Basti: 480 ml/Basti

·       Anuvasana Basti:. 60ml /Basti

Kala:

·       Niruha Basti should always be given empty stomach or when the previous food has been digested but the appetite is not evoked.

·       Anuvasana Basti on the contrary, should never be administered before meals.

Pratyagaman kala:

The time period in which the Basti Dravyas return back is Pratyagaman Kala. The maximum Pratyagamana Kala for Niruha Basti has been assigned as one Muhurta (app. 48 mins.)

For Anuvasana Basti, however, the maximum time limit is three Yaam (12 hrs). For Niruha Basti, if Pratyagama doesn’t occur then Phalavarti or Tikshna Basti may be introduced.

Yoni pichu:

All procedures to be done under all aseptic precautions.duration of procedure 7days minimum.

Equipments required: autoclaved pichu,sterile gloves,sterile cotton swabs.

Procedure :

1.     ask the patient in supine position with knees flexed.

2.     Clean vulva and vagina with antiseptic solution.

3.     Sterile pichu soaked in medicated ghee/oil shouldbe taken and has to be inserted in vaginal canal with tail lying outside vagina.

4.    Guide patient to take out the pichu after 2 hrs or until urge of urination**.**

Assessment Criteria-

The clinical result will be  assessed by observing whether the pregnant woman will have Sukha and Nirupadrava Prasava or not and for that the following parameters will be  adopted.

• Bishop’s Score
• Labour progress according to Partogram
• Total duration of labour
• Duration and frequency of uterine contractions
• Fetal weight by USG
• Mode of delivery
• Onset of labour

§  Induction/Augmentation required or not required

A.Grade-0

Onset of Labour - Spontaneous

Partogram - Before Alert Line

Uterine Contractions - Normal Pattern

Type of Delivery - Spontaneous Vaginal Delivery without Episiotomy

Grade-I

Onset of Labour - Spontaneous

Partogram - Before Alert Line/ Between Alert Line &Action Line

Uterine Contractions - Normal Pattern

Type of Delivery - Spontaneous Vaginal Delivery with Episiotomy or with perineal tear

Grade-II

Onset of Labour - Induced

Partogram - Before Alert Line between Alert Line &Action Line

Uterine Contractions - Normal Pattern/Irregular Pattern

Type of Delivery - Spontaneous Vaginal Delivery with or without Episiotomy.

Grade-III

Onset of Labour - Spontaneous/Induced

Partogram - After Alert Line

Uterine Contractions - Irregular Pattern

Type of Delivery - L.S.C.S.

B. Duration of Uterine contraction :

0 = > 60 Seconds

1 = 46 – 60 seconds

2 = 31 – 45 Seconds

3 = < 30 Seconds

 Frequency Of uterine Contraction :

0 = 4 contractions /10 Minutes

1 = 3 contractions /10 Minutes

2 = 2 Contractions /10 Minutes

3 = 1 Contraction /10 Minutes

C. Bishop’s Score :

0 = 10 – 13 Score

1 = 7 – 9 Score

2 = 4 – 6 Score

3 = 1 – 3 Score

BISHOP’S MODIFIED SCORING:

Each components is given a score of 0-2 or 0-3. The highest possible score is 13.

0

1

2

3

|Cervical Dilatation(cm)

Closed

1-2

3-4

5+

|Cervical Length(cm)

4

3-4

1-2

<1

|Cervical Consistency

Firm

Medium

Soft

|Cervical Position

Posterior

Midline

Anterior

|Head station

-3

-2

-1,0

+1,+2

indicator

O points

1 point

2 points

|A

Activity

( muscle tone)

Abesnt

Flexed limbs

Active

|P

Pulse

Absent

<100 bpm

100bpm

|G

Grimace (reflex irritability)

Floppy

Minimal response to stimulation

Prompt response to stimulation

|A

Appearance

Blue pale

Pink body blue extremeties

Pink

|R

Respiration

Absent

Slow and irregular

Vigorous cry

               A - severely depressed         0-3

B - moderately depressed    4-6

C- excellent condition         7-10

 Pain threshold during labour:                                             Score

 

Severe labour pain (Poor pain threshold)                                     3

|Moderate                                                                                      2

|Mild (Good)                                                                                 1

 Bearing down efforts: (Pravahana)

 

Very good effort                                                                          3

|Good effort                                                                                  2

|Poor effort                                                                                   1

After Pains :

 

Severe Pain                                                                                  3

|Moderate pain                                                                              2

|Mild pain                                                                                     1

|No pain                                                                                        0

Post partum bleeding:

 

Severe bleeding (more than 500 ml)                                            3

|Moderate bleeding (351 - 500 ml)                                                2

|Mild bleeding (201 - 350ml)                                                        1

|Normal bleeding (l00 - 200 ml)                                                    0

WITHDRAWAL CRITERIA

 Â·       If there is any complication.

·       If the condition of the patient deteriorates during the trial.

·       Patient not willing to continue in the study or incompliance for 3 or more than that days .

 RESCUE MEDICATION & ADR

If there is any occasion of adverse effect, additional pharmacological drugs will be prescribed in consultation with the contemporary medical practitioners or other ayurvedic drugs will be administered in consultation with the experts in the field.

If Any adverse drug reaction observed By Doctor or Patient it will be recorded and  reported to Pharmacovigilance center, AIIA,New Delhi.

 ETHICS COMMITTEE CLEARENCE:

Study will be started after getting clearance from Institutional Ethics Committee., and after CTRI Registration

Reporting of ADR (Adverse Drug Reaction), if any observed by doctor/patient will be reported to the specific authority. Pharmacovigilance center, AIIA,New Dlhi

STUDY MONITORING:

The study will be monitored at Department of Striroga evam Prasuti Tantra,All India Institute by Guide, Co-guides and faculties of the department.

PATIENT COMPLIANCE PROTOCOL :

·       Participants will be provided with a compliance chart which they will be required to fill every day.

·       Participants will be monitored on regular basis through call/whatsapp.

·       Minimum 80% compliance is must to continue the study.

·       Treatment plan,its importance,potential side effects,expected outcomes will be explained to the participants in the way they can understand.

 CONFIDENTIALITY:

·       The information that we collect from the study project will be kept confidential.

·       Information on your health and mental status(as the case may be) that will be collected while conducting the research will be kept confidential and no one but the researchers will be able to find it also all the information about the participant will be coded.

·       Only the All India Institute of Ayurveda Ethics Committee and other regulatory bodies under Government of India law would have access to these records.

 TRANSLATIONAL VALUE O F THE RESEARCH :

•       Present study could help validate and promote the use of this traditional medical practice like basti and vaginal tampon in modern obstetrics

•       It could reduce the occurrence of surgical complications in childbirth which might have broader implications for maternal and infant health .This could translate into shorter labor duration ,potential to reduce healthcare costs

CO-OPERATION REQUIRED:

• Identification of the raw drug from Department of Dravyaguna

• Pathology Lab, AIIA Hospital

• Library, AIIA Hospital

• Pharmacy, AIIA Hospital

• Preparation of medicines from the department of rasa shastra AIIA

•OPD &IPD, AIIA Hospital If needed help will be taken from other departments of AIIA with due permission from concern authority during the course of study.

 STUDY ENDPOINTS:

 PRIMARY

 1.Improvement in BISHOP score ( > 8)

SECONDARY

 1.Improvement in APGAR Score.

 Â·       Outcomes will be assessed by the BISHOP score and  APGAR Score tables  given in the assessment criteria.

·       Bishop score of 8 or greater is considered to be favorable for induction, or the chance of a vaginal delivery with induction is similar to spontaneous labor.  A score of 6 or less is considered to be unfavorable if an induction is indicated cervical ripening agents may be utilized.The most common modification to the Bishop score is a simplified scoring system that just takes into account dilation, effacement, and station (each scored 0 to 3 points). In this shortened modification, a score of more than 5 is considered favorable.

·       If APGAR score is 0-3 baby will be considered as severely depressed,4-6 as moderately depressed and 7-10 as excellent condition .

  FINANCIAL SUPPORT:

This study will be completed within the prescribed financial limit for the work. However, if more finance is required, the request will be made for due permission and approval of extra budget to the concerned authority AIIA, in due course of research work.

No

TASK

COST

|1.

Investigations

20,000

|2.

Medicines

60,000

 Total – 80,000

                                           GANTT CHART:

ACTIVITIES

June  2023

July 2023-Sept 2013

Sept 2023-

Oct 2023

Oct 2023

Nov23-Jan 2024

February 2024

 April 2024-May  2025

June 2025-aug 25

Sep   -

Oct

2023

|·       Selection research

Problem

of

          |·       Review literature

of

          |·       Preparation Synopsis

of

          |·       Submission Synopsis

of

          |·       Presentation synopsis

of

          |·       Re-Evaluation of synopsis

after IRB suggestions

          |·       Resubmission of synopsis

          |·       Preparation    of patient consent form,       patient information sheet,          case

record forms

          |·       IEC clearance

          |·       Procurement and preparation of trial drugs

          |·       Recruitment subjects

of

          |·       Commencement of trial

          |·       Data analysis

          |·       Submission thesis

of

LIST OF REFERENCES

1.Prof.Siddhi  Nandan  Mishra.  Bhaisajya  Ratnavali  by  Kaviraj  Govindnath  Sen  Siddiprada , Hindi  commentary,  Garbhinirogadhikar  68/57.  Reprint  2011.  Varanasi:   Chaukambha Surbharti Prakashan; 2011.p. 1057.

2.Prof.Siddhi  Nandan  Mishra.  Bhaisajya  Ratnavali  by  Kaviraj  Govindnath  Sen  Siddiprada,  Hindi  commentary,  Jwarrogadhikar 5/1268.  Reprint  Varanasi:  Chaukambha Surbharti Prakashan:  2011.P.206.

3.Prof.Siddhi  Nandan  Mishra.  Bhaisajya  Ratnavali  by  Kaviraj  Govindnath  Sen  Siddiprada,  Hindi  commentary,  Garbhinirogadhikar  68/57..  Reprint  2011  Varanasi:   Chaukambha Surbharti Prakashan;  2011;p.1057.

4.D.C  Dutta,  Text  Book  Of  Obstetrics  Including  Perinatology  And  Contraception, Edited By  Hiralal Konar.   7th  Edition.  Reprint  2011.New Central Book  Agency:  Londo; 2011.p.131.

5.Dr.Ravi  Dutta  Tripathi.  Ashtang  sangraha  Saroj,,  Hindi  Commentary  Sutrasthan  1/48 .Reprint  2001.  Varanasi; Chukambha Prakashan,  20.

6.Bhavprakash  Nighantu,  Indian Materia  Medica.  Bhavmishra,  Bharati Acadamy,  Varanasi  ,  10th  edi,  1995

7.Kashinath  Pandey  And  Gorakhnath Chaturvedi . Charak  samhita  Vidyotini vyakhya  Part  –I,.  Shareer  Sthan  6/24, Reprint  2009.  Varanasi:  Chaukambha Bharti Academy:  906.

8.Sushrutsamhita with Ayurveda TatvaSandipika Hindi commentary, KavirajAmbikaDuttaShastri Part-1, Reprint 2008. Chaukhamba Sanskrit SansthanSharirSthan,Garbhinivyakararan sharir adhyaya 10/5

9.Vaidya  Vijay Shankar Kale. Charak  samhita with Vaidyamanorama hindi commentary,Vimansthana rogbhishagjitiya adhyaya 8 ,shloka no 139.

10. Vaidya  Vijay Shankar Kale. Charak  samhita with Vaidyamanorama hindi commentary,Sharirsthan jatisutriya shariradhyaya 8/31/4

11. Vaidya  Vijay Shankar Kale .Charak  samhita with Vaidyamanorama hindi commentary,Sharirsthan Sharirvichaya sharirad.

12.Meenakshi Pal, Sushila aSharma and B. Pushpalatha ROLE OF ANUVASANA BASTI WITH PICHU AND SUKHAPRASAVAKARA YOGA ON PROGRESS OF LABOUR, World Journal of Phrarmaceutical Research,5(4),852-866

13.Jadhav Archana S ,Ghorpade Manda ,Study of efficacy of bala sidhha taila pichu on cervical ripening and effacement,International Journal of Reseach in Indian Medicine,1(3),2017

14.Dr Verma Neha,Dr Bagali C.S,Role of Kadamba Mash Tail Anuvasana Vasti In The Ninth Month of Pregnancy For Sukhaprasava,PIJAR,3(2),2018.

15K.Prameela Devi and P.V. Tiwari,COMPARATIVE STUDY OF BALADI TAIL AND TILA TAILA PICHU IN THE MANAGEMENT OF PRASAVA,J.R.A.S.3(4),2009