A Controlled clinical study to evaluate the efficacy of Saptasaramghana vati and Chandraprabha vati in the management of Udavartini Yonivyapad (primary dysmenorrhea)

6.  BRIEF RESUME OF THE INTENDED WORK6.1 NEED FOR STUDY

Menstruation is one of the physiological process seen in reproductive phase, which denotes the healthy state of female reproductive system.In today’s fast moving competing world, women need to be multi-tasking,the process of menstruation will cause minimized disturbance in day to day activities,if this menstruation is associated with pain then it is still more annoying,this will again cause difficulty for a women to lead her daily activities and balance work and family,menstruation associated with pain is called as dysmenorrhea.

Dysmenorrhea is the most important cause of chronic pelvic pain and the disease burden of dysmenorrhea is estimated to be greater than any other gynecological morbidity, in women of reproductive period . The epidemiology of primary dysmenorrhea is 25 to 90% among women and adolescents respectively.1 Studies from India reported the prevalence range between 50% to 87.8 % of women of reproductive age.2

Dysmenorrhea is mainly of two types primary dysmenorrhea and secondary dysmenorrhea, The primary dysmenorrhea is one where there is no identifiable pelvic pathology and secondary dysmenorrhea is normally considered to be menstruation with pain in presence of pelvic pathology.3

The clinical feature of the primary dysmenorrhea includes recurrent cramp suprapubic pain which may radiate to back and thighs occurring just before or during menses and lasting two or three days, pain may radiate into the lower back and thighs and may be associated with nausea, fatigue, bloating and general malaise, vomiting and diarrhea.3

The dysmenorrhea can be correlated withUdavartini Yonivyapad in Ayurveda. Udavartini Yonivyapad is characterized asVedana Yukta Artava Munchan a complaint with spasms andcontraction. The Vedana Yukta Artava Munchan, this condition can be easily identified with the clinical entity of Primary dysmenorrhea in modern gynecological parlance. Primary dysmenorrhea is menstrual pain without pelvic pathology which incapacitate day today activities of a women.4

In AyurvedaApana-Vayu has been given prime importance in Stree rogaas it does the Arthava Niskaraman in Stree.Due to the causative factors like Vata kara Ahara Vihara, the Apana Vayu get aggravated and causesPratiloma Gati of Apana Vayu,which leads topain,So

painful menstruation is considered to beApana-vayu dusti. Charaka first described Udavarta in Vataja Nanatmaja diseases.5In this Rajas is pushed in upward direction by the aggravated Apana Vayu due to obstruction in its normal flow and causes pain during menstruation.6

As Vata is the causative factor for Udavartini Yonivyapad, so it should be treated first. Hence Saptasaram Ghana Vati is one such formulation explained in Sahasrayogawhich act as Yoni Shoola,7along with this almost the contents are having Katu, Tikta, kashaya Rasa Yukta,Ushana Veerya, Madhuraand Katu Vipaka, Vata Kapha Shamaka, Shoolaprashamana which will be useful in treatingUdavartini Yonivyapad. Hence the Saptasaranghana vati is been taken for this study.

6.2  REVIEW OF LITERATUREl  Nidana, Lakshana, Samprapti of Udavarta yonivyapad are explained in Charaka SamhitaChikitsaSthana,8Sushruta Samhita Uttara tantra,9 *Astanga Hridaya Uttara tantra.*10

l  Vataja Yonivyapad Chikitsa is been described in Charaka Samhita Chikitsasthana.11

l  Saptasaram kashaya is indicated as Yoni Shoolain Sahasrayoga.7

  DRUG REVIEW – SAPTASARAM GHANA VATI

Table 01. Rasa Panchaka and Karma of the ingredients in Saptasaram Ghana Vati12

S.N

DRUG

LATIN

NAME

PART

USED

RASA

GUNA

VIRYA

VIPAKA

KARMA

|1.

Varshabhu

Boerhaavia diffusa

Root

Madhura,

Tikta, Kashaya.

Laghu, Ruksha

Ushna

Katu

Tridosha hara

|2.

Bilwa

Aegle marmelous

Root

Kashaya, Tikta

Laghu, Ruksha

Ushna

Katu

Vata and kapha

shamaka

|3.

Khalva purana

Dolichos biflorus

Seed

Kashaya

Laghu,

Ruksha, Tikshna

Ushna

Katu

Kapha

Vata shamaka

4.

Urubu

Ricinus Communis

Root

Madhura, Katu,

Kashaya

Laghu, Ruksha,

Tikshna

Ushna

Madhura

Vata Kapha

shamaka

|5.

Sahachara

Barleria prionitis

Root

Tikta, Madhura

Laghu,

Ushna

Katu

Kapha Vata

shamaka

|6.

Shunthi

Zingiber officinale

Rhizome

Katu

Guru, Ruksha,

Tikshna

Ushna

Madhura

Kapha Vata

shamaka

|7.

Agnimanta

Premna integrifolia

Root

Tikta, Katu, Kashaya

Madhura

Ruksha, Laghu

Ushna

Katu

Kapha Vata shamaka

**Table****02:       Showing       the       Rasa                 Panchakas&Doshaghnataof            herbal drugsusedinthepreparationof Chandraprabha vati.12,13

S.NO

DRUG

LATIN NAME

GUNA

RASA

VIPAK A

VEERY A

KARMA

|1

Karpura

Cinnamo

mumcamp hora

Laghu,ruksha

Tikta,katu, Madhura

Katu

Sheeta

Kaphahara

|2

Vacha

Acoruscata

mus

Laghu,Tikshna

Katu,Tikta

Katu

Ushna

Kapha-

Vatahara

|3

Musta

Cyperusrot

undus

Laghu,Ruksha

Tikta

Katu

Sheeta

Kapha-

Pittahara

|4

Bhunimba

Swertiachirat

a

Laghu,

Ruksha

Tikta

Katu

Sheeta

Kapha-

Pittahara

|5

Guduchi

Tinosporac

ordifolia

Guru,Snigdha

Tikta,Kashaya

Madhura

Ushna

Tridosha

hara

|6

Devadaru

Cedrusdeod ara

Ruksha,Laghu

Tikta,Katu,Ka shaya

Katu

Ushna

Kapha-

Vatahar a

7

Haridra

Curcumalong a

Ruksha, Laghu

Tikta, Katu

Katu

Ushna

Kapha- Vatahar

a

|8

Ativisha

Aconitum Herophyllu

m

Laghu,Ruksha

Katu,Tikta

Katu

Ushna

Tridosha hara

|9

Daruharidra

Berberisaris

tata

Laghu,Ruksha

Tikta,Kashaya

Katu

Ushna

Kapha-

Pittahara

|10

Pippalimula

Piperlongum

Laghu, Ruksha

Katu

Katu

Ushna

Kapha-

Vatahar a

|11

Chitraka

Plumbagoz eylanica

Laghu,Ruksha, Tikshna

Katu

Katu

Ushna

Vata- Kaphaha

ra

|12

Dhanyaka

Coriandrum

sativum

Laghu,Snigdha

Kashaya,Tikta

Madhura

Ushna

Tridosha

hara

|13

Haritaki

Terminaliac hebula

Laghu,Ruksha

Pancharasa(e

xcept lavana)

Madhura

Ushna

Tridosha hara

|14

Bibhitaki

Terminaliab

ellerica

Ruksha,Laghu

Kashaya

Madhura

Ushna

Kapha-

Pittahara

|15

Amalaki

Emblicaoffici nalis

Guru

Pancharasa (exceptlavana)

Madhura

Sheeta

Tridosha hara

|16

Chavya

Piperchaba

Laghu,Ruksha

Katu

Katu

Ushna

Kapha- Vatahar

a

|17

Vidanga

Embeliaribe s

Laghu,Ruksha, Tikshna

Katu,Kashaya

Katu

Ushna

Vata-

Kaphaha ra

|18

Gajapippali

Scindaspus Officinalis

Laghu,Ruksha

Katu

Vata-

Kapha Hara

19

Pippali

Piperlongu m

Laghu, snigdha

,

Katu

Madhura

Ushna (dry) Sheeta

(wet)

Vata- Kaphaha ra

|20

Maricha

Pipernigru m

Laghu,Tikshna

Katu

Katu

Ushna

Kapha- Vatahar

a

|21

Shunti

Zingiberoffi cinale

Guru,Ruksha, Tikshna

Katu

Madhura

Ushna

Vata- Kaphaha

ra

|22

Trivrt

Operculina

turpethum

Laghu,ruksha,

Tikshna

Tikta,Katu

Katu

Ushna

Kapha-

Pittahara

|23

Danti

Baliosperm

ummontanu m

Guru,Tikshna

Katu

Katu

Ushna

Kapha-

Vatahar a

|24

Patraka

Cinnamom umtamala

Tikshna,Laghu

,Pichila

Madhura

,Katu

Katu

Ushna

Kapha- Vatahar

a

|25

Twak

Cinnamomum

Zeylanica

Laghu,Ruksha,

Tikshna

Katu,Tikta,

Madhura

Katu

Ushna

Vata-

Pittahara

|26

Ela

Elettariacor

damomum

Laghu,Ruksha

Katu,Madhura

Katu

Sheeta

Kapha-

vatahara

|27

Vamsha(V.lo chana)

Bambusa Arundinace

ae

Laghu,Ruksha

Madhur,kasha ya

Madhura

Sheeta

Kapha- Pittahara

|28

Guggulu

Commiphora mukul

Laghu,Ruksha, Vishada,Suksh ma

, Sara(Old)

Snigdha,Pichil a(New)

Tikta,katu

Katu

Ushna

Tridosha hara

29

Sharkara(Iksh

u)

Saccharum

officinarum

 Madhura

Madhura

Sheeta

Vata-

Pittahara

Table2.1 :ShowingthedetailsofLavanas(Lavanavarga)usedinpreparationofCh andraprabha Vati**.14**

S.N

Sanskrit

name

English

name

Latin

name

Rasa

panchaka

Karma

|1

Saindhava

Rocksalt

Sodii

Guna-

Tridosha

|Lavana

Chloridum

Laghu,Snigdha,

shamaka

|  Sukshma

  |  Rasa-

  |  Lavana

  |  Vipaka-Katu

  |  Virya-Sheeta

  |2

Sauvarchala

Sochalsalt

Unaqua

Guna-Laghu,

Vatashamaka

|Lavana

Sodium

Vishoda,Sukshma,

| Chloride

Snigdha

|  Rasa-Madhura

|  Vipaka-Madhura

|  Virya-Ushna

|3

Bidalavana

Amonium

Amonium

Guna-Laghu,

Vatashamaka

|Chloride

Chloride

Sukshma,Tikshna

|  Rasa-Lavana

|  Vipaka-Madhura

|  Virya-Ushna

Table2.2 **:ShowingthedetailsofmineraldrugsusedinthepreparationofChandrapr abhaVati.15

S.N

SANSKRI

T NAME

CHEMICAL

NAME

CHEMICAL

FORMULA

RASA

PANCHAKA

KARMA

|1

Makshika bhasma

Copperpyrite s/Chalcopyri tes

Cu2Fe2S4

Laghu guna,Madhura, amla rasa,Katu vipaka,

Sheetaveerya

Tridoshashama ka

|2

Lohabhasma

Iron

Fe2O3

Tikta rasa,

Madhuravipaka, Sheetaveerya

Kapha Vatashmaka

|3

Shuddha Shilajatu

Blackbitumen

Tikta, Katu rasa,Katuvipaka,Ushn a

Veerya

Kaphashamaka

**Table2.3:ShowingthedetailsofKsharasusedinthepreparationofChandraprabhaV ati.16

S.N

SANSKRIT

NAME

ENGLISH

NAME

SYNONYMS

RASA PANCHAKA

KARMA

|1

Sarja

Obtainedfrom

Svarjikakshara,

Laghu,Ruksha,Ushna,

|Kshara

Ushtrapriya

Sarjika,

Tikshna

| (RT)

Sukhorchika

  |2

Yava

Mixtureof

Yavapatya,

Laghu,Snigdha,Sara

Kapha-Vata

|Kshara

potassiumsalts

Yavaja,

Guna

shamaka

| (Obtainedfrom

 Katurasa,Katuvipaka,

  | husk& grass of

 Ushnaveerya

  | yava/barley)

PREVIOUS WORK DONEØ  Udayakala P, Clinical management of Udavartini Yonivyapad with Sukumara ghrita

w.s.r. to primary dysmenorrhea. Prasutitantra Stri Roga, Shri Dharmasthala manjunatheshwara college of Ayurveda and Hospital, Hassan, 2014.

Ø  Nanda K. A clinical study to evaluate the effect of Erandamooladi Niruha Vasti in Udavartini Yonivyapad w.s.r. to Primary dysmenorrhea. Prasutitantra and Stri Roga, Shri Dharmasthala manjunatheshwara college of Ayurveda and Hospital, Hassan, 2014.

Ø  Niveditha S. A clinical study to evaluate combined effect of Chandraprabha Vati with Haritaki Churna on Udavartini Yonivyapad w.s.r to Spasmodic dysmenorrhea, Prasuti Tantra and Stri Roga, Shri Jagadguru Gavisiddheshwar Ayurveda Medical college and Research Centre, Koppal, 2015.

Ø  Rachana A S, A clinical study to evaluate the efficacy of Higwadi Vati in Udavartini Yonivyapad w.s.r to Primary dysmenorrhea, Prasuti Tantra and Stri Roga, Alva’s Ayurvedic Medical College, Moodbidri 2015.

Ø  Rajalaxmi Ravindrum, Aclinical study to evaluate the efficacy of Tilvakadi Ghrit in Udavartini w.s.r to Primary dysmenorrhea, Prasuti Tantra and Stri Roga, Alva’s Ayurvedic Medical College, Moodbidri 2015

Ø  Rashmi verma, A Open label comparative clinical study to evaluate the Antispasmodic effect of Kumarika Vati and mefenamic acid in the management of Udavartini Yonivyapad (Spasmodic dysmenorrhea), Prasuti Tantra and Stri Roga, Shri Jagadguru Gavisiddheshwar Ayurveda Medical college and Research Centre, Koppal, 2021.

 6.3  AIMS AND OBJECTIVE OF STUDY·     To evaluate the efficacy of Saptasaramghana Vati in the management of Udavartini Yonivyapad (Primary dysmenorrhea) .

·     To compare the efficacy of Saptasaramghana Vati and Chandraprabha Vati in the management of (Primary Dysmenorrhea).

7.  MATERIAL AND METHODSHypothesisH0: There is no statistical significance of Saptasaram Ghana Vati in the Management

Udavartini Yoni Vyapad (Primary dysmenorrhea)

**H1:**There is statistical significance of Saptasaram Ghana Vati in the Management

Udavartini Yoni Vyapad (Primary dysmenorrhea)

H2: There is statistical significance ofChandraprabha Vatiin the management of

Udavartini Yoni Vyapad (Primary dysmenorrhea)

H3: Both Saptasaramghana vati and Chandraprabha Vati have equivalent statistical significance the management of Udavartini Yoni Vyapad (Primary dysmenorrhea)

7.1  SOURCE OF DATAA) LITERARY SOURCE

All the Ayurvedic, Modern literature and contemporary texts including the authenticated web journals about the disease and treatment will be reviewed and document for the intended study.

B)  SAMPLE SOURCEPatients attending OPD of the Dept of Prasooti Tantra&Streeroga of S.J.G.A.M. College & Research center, Koppal and other referral source will be taken for the study.

C)  DRUG SOURCEThe drugs required for the study will be procured from an authenticated pharmacy under the supervision of Dept. of Dravya Guna and Rasashastra and Bhaishajya Kalpana of S.J.G.A.M. College and Research center Koppal.

7.2  METHODS OF COLLECTIONS OF DATA1) STUDY DESIGN

A controlled clinical trial

 2)  SAMPLE SIZEThis is a controlled clinical study with 40 patients fulfilling the inclusion criteria will be selected and randomly allocated into two equal groups containing each 20 patients: Group A (trail group) and Group B (control group).

A.    INTERVENTIONSGroup A is a Trail group of 20 patients who will be treated with the Saptasaram Ghana Vati in the dosage of 500mg BD before food for 5days, 3days before expected date of menses and 2days after the start of menses, for 3 consecutive cycles.

Group B is a control group of 20 patients who will be treated with the Chandraprabha Vati in the dosage of 500mg BD before food for 5 days, 3days before expected date of menses and 2days after the start of menses, for 3 consecutive cycles**.**

Study Duration - 6cycles

Treatment period - 3 cycles

**Follow up –**3rdday of next 3 consecutive cycle after treatment.

 B.METHOD OF PREPARATION OF SAPTASARAM GHANA VATIIngredients (Kalka Dravyas) numbered 1 to 7 in the composition will be taken dried and powdered and will be passed through sieve number 44.The powdered ingredients will be transfered into a stainless steel vessel and sufficient quantity of water will be added to soak it overnight. On the following day water will be again added to make it 16 parts of Kalka Dravya. The above ingredients will be boiled on mild fire by keeping lid open till the total quantity is reduced to 1/8th. Later the Kwatha will be filtered through a muslin cloth. This filtrate will be further boiled on mild fire to obtain a semisolid content called Ghana. It will be dried in shade and will be rolled into pills called Ghana Vati.17

3)  SELECTION CRITERIAA. DIAGNOSTIC CRITERIA

·       Patients having primary dysmenorrhea.

·       Patients between ages of 15 to 35.

·       Patients having regular menstrual cycles.

 B.    INCLUSION CRITERIA·       Patients suffering from primary dysmenorrhea

·       Both married and unmarried women age group between 15-35 years

·       Patients suffering for more than 3 consecutive cycle

·       Patients with regular menstrual cycle.

C.    EXCLUSION CRITERIA·       Patient having secondary dysmenorrhea

·       Patient with abnormal uterine bleeding

·       Patient with dysfunctional uterine bleeding

·       Patient with any systemic illness

·       Structural pelvic pathology

·       Patient with IUCD, Pelvic organ infection, uterine polyps, endometriosis, fibroiduterus.

·       Congenital anomalies of female reproductive system

·       Lactating mother

 D.    Assessment Criteria·       Interval between the cycles

·       Associated complaints

·       Pain Intensity

·     Pain Duration

·       Site of pain

Assessment of ResultsSubjective and objective parameters will be compared and statistically analyzed using the readings of before and after the treatment.

 SUBJECTIVE PARAMETERS·       Interval between the cycles

·       Associated complaints –Nausea Vomiting

Headache

OBJECTIVE PARAMETERS·       Pain Intensity

·       Pain Duration

·       Site of pain

GRADINGSInterval between the cycles

Interval between the cycles

Grade

|28-30 Days

0

|31-34Days

1

Associated complaints

Changes in associated complaints

Grade

|Associated complaints absent

0

|Associated complaints present

1

Pain intensity based on Visual pain analogue scalein analogue scale

Pain intensity

Grade

|No pain

0

|Mild (1 - 3)

1

|Moderate (4 - 7)

2

|Severe (8 - 10)

3

Pain duration

Pain duration

Grade

|No pain

0

|Previous day and 1st day

1

|2nd and 3rd day

2

|4th day

3

Site of pain

Site of pain

Grade

|Pain in Supra-Pubic region

1

|Pain in Supra-Pubic region & lumber region

2

|Pain in Supra-Pubic Lumber & Thigh region

3

STATISTICAL ANALYSISA detailed proforma will be prepared and assessment is done on graduations given for the Parameters. The data will be analysed using Wilcoxon Signed Rank test and Mann- Whitney U test.

Investigations:·       Ultrasonography of abdomen and pelvis

·       Hb gm%

 7.3  Does the study require any investigation or interventions to be done on patients or other humans or animals? If so please describeYes the study will be conducted clinically on humans. No animal experimentation will be carried out.

7.4  Has ethical clearance been obtained from your institution in case?Yes, obtained and enclosed.

  List of References1.       https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2853792/

2.       Nahal Habibi Msc, Mary Soo, Lee Hung PhD, Wan Ying Gan Phd, Rejaji Zulida MD, Sayyed Morteza Safavi Phd, Prevalence of Primary dysmenorrhea And Factors Associated with Its Intensity Among Undergraduate Student, A Cross Sectional Study, https//doi.org/10.1016/j.pmn.2015.07.001.

3.       Hiralal Konar, D.C. Datta Text Book of Gynecology, Jaypee Brothers Medical Publishers, 6th Edition 2013, Page No.178.

4.       Shashikala karanth, S.R. Liya, Prevalence and Risk Factors for Dysmenorrhea Among Nursing Student and Its Impact on Their Quality of life, International Journal of Reproductive, Contraception, Obstetrics and Gynecology, July 2018 Page No. 2661-2667

5.       Agnivesha. Charaka Samhita sutrasthana 20/13, Chaukhambha Sanskrit Series Office, Varanasi, 2009. Page No. 113

6.       Agnivesha. Charakasamhita chikitsasthana 30/110-120, Chaukhambha Sanskrit Series Office, Varanasi, 2009, Page No. 635-645

7.       Dr.G.Prabhkara Rao, Sahasrayogam, compendium of 1000+ Ayurvedic formulations. Sanskrit Text with English Translation and Prabhakara Vyakhyanam CHAUKHAMBHA PUBLICATIONS NEW DELHI Page no.209

8.       Agnivesha. Charaka Samhita chikitsa sthana 30/8,25,26, Chaukhambha Sanskrit Series Office, Varanasi, 2009. Page No. 636.

9.       Yadavji Trikamji Acharya, Sushruta Samhita Uttar Tantra 38/6,11, Chaukhambha Sanskrit Sansthan, Varanasi, 2014. Page no. 668, 669.

10.    Vagbhatta, Ashtanga Hridaya Uttar Asthana 33/33, Chaukhambha Sanskrit Sansthan, Varanasi, 2014. Page no. 895.

11.    Agnivesha. Charaka Samhita chikitsa sthana 30/47, Chaukhambha Sanskrit Series Office, Varanasi, 2009. Page No. 637.

12.    Dr. J L N Sastry forewaed by Prof. K.C.Chunekar, DRAVYAGUNA VIJNANA study of essential medicinal plants in Ayurveda. Vol. 2, CHOWKAMBHA OREINTELIA VARANASI 221001.

13.    Dr.G.Prabhkara Rao, Sahasrayogam, compendium of 1000+ Ayurvedic formulations. Sanskrit Text with English Translation and Prabhakara Vyakhyanam CHAUKHAMBHA PUBLICATIONS NEW DELHI Page no.418

14.    Prof.shanth kumar Lucas, Dravyaguna vignana, vol 2, chaukambhavishwabharati, Varanasi, Reprint 2013, Pp-760,761,762

15.    P.Himasagara Chandra murthy, Rasa shastra, the mercurial system, chaukambha Sanskrit series office, Varanasi, second edition2011,Pp223,228,326,327,334.Dr.Vilas A Dole, A text book of Rasashastra, Reprinted 2012, P- 198,202

16.    P.Himasagara Chandra murthy, Rasa shastra, the mercurial system, chaukambha Sanskrit series office, Varanasi, second edition 2011, Pp- 423,424,425.

17.    Anonymous, The AyurvedicFormulary of India, part 2, 2nd ed. New Delhi:Govt of India published by the controller of publication p.183.