A Clinical Study To Evaluate The Efficacy Of Kashyapi Care Kit In The Management Of Sutika Paricharya W.S.R. To Postpartum Care.

INTRODUCTION :

-          In Ayurveda, the term Sutika can be used only after expulsion of placenta. During Puerperium the body tissues, especially the pelvic organs revert back approximately to prepregnant state both anatomically & physiologically.

-          After delivery the woman become emaciated and have Shunyashareera because of Garbhavriddhi, Shithilasarvashariradhatu, Pravahanavedana, Kledarakta-nisruti, Agnimandya, these will lead to Dhatukshaya hence extra care to be given to prevent complication during this period to avoid 74 types of disease which can happen in this period if not managed properly.

-          So Ayurveda told a specific regimen so that the Sutika attains all lost things and reaches her pre pregnancy stage as it helps in Garbhashaya shuddhi, Dhatu paripurnata, Stanya Vriddhi and Punarnavakarana.

-          This particular study on Sutika Paricharya focusses on the regimen to be followed during puerperal period to prevent further complications and restore the health of mother.

-          The woman after such difficult process of Prasava must be advised to follow special dietary regimen and life style called Sutika paricharya. Present study protocol of Sutika Paricharya is divided into three major components as follows.

1. Ashwasana (Psychological Reassurance)

2. Vihara (Normal daily activities and therapeutic procedures)

3. Aahara (Normal diet in puerperium)

• This regimen is designed to promote the purification of the reproductive organs (Garbhashaya shuddhi), ensure completeness of bodily tissues (Dhatu paripurnata), enhance breast milk production (Stanya Vriddhi), and facilitate overall rejuvenation (Punarnavikarana).

 NEED OF STUDY:

-          To prevent complications of the Puerperal period.

-          To provide basic health care to the mother.

-          To provide nutritional and socio-economic nourishment to the mother for the proper breast willing.

-          So care of the Sutika, her diet and its regimen should be done very carefully because if  there is any disease in this period than it can be cured with great distress, because of the    fetal growth all Dhatus of her body are decrease and because of labour pain, amniotic fluid secretion and bleeding the whole body becomes very weak so its care should be taken strictly.

 AIM:

-          To study the efficacy of KashyapiCareKit in the management of Sutika Paricharya.

 OBJECTIVES:

-          To study about the concept of Sutika and its Paricharya.

-          To understand clinical importance of Sutika Paricharya.

-          To observe the efficacy of Kashyapi Care Kit in Sutika Paricharya.

-          To develop a 7 days standardized and systematic protocol for Sutika.

 HYPOTHESIS:Null Hypothesis- (H0)

There will be no significant effect of Kashyapi Care Kit in the management of Sutika Paricharya.

 Alternative Hypothesis- (H1)

There will be significant effect of Kashyapi Care Kit in the management of Sutika Paricharya.

**Criteria for assessment:**1. Subjective Parameters :

-          Agni

-          Stanya pravritti

-          Udarshoola

-          Katishoola

-          Nidra

 2.      Objective Parameters :

-          Involution of Uterus.

-          Lochia

-          Abdominal girth

-          Depression and anxiety.

-          Episiotomy wound healing.

-          Temperature, Blood Pressure and Pulse.

Investigations :-          HB %  & RBS

-          HIV/HbSAg/VDRL

-          Sickling Test

 WITHDRAWAL CRITERIA:

-         If any serious condition develops during the course of trial which requires urgent treatment.

-         Patient herself wants to withdraw.

-         Patient who will not come for the follow ups.

MATERIAL AND METHODS

SOURCES OF DATA

LITERATURE SOURCE-

All available literature on Sutika and Sutika paricharya will be referred, including the Samhitas and other ancient and modern books, as well as other texts of allied medical science, journals, research papers, and web material.

 CLINICAL SOURCE-

Minimum 30 postpartum women fulfilling the inclusion criteria attending the OPD and IPD of Parul Ayurved Hospital, Parul Sevaashram Hospital, Limda and Khemdas Ayurved Hospital, Vadodara will be taken for the study.

 DRUG SOURCE**: -**

Raw drugs required for preparation of Kashyapi care kit will be procured from standard suppliers and identification and authentication of it will be in Ras shashtra & Bhaishajya kalapana Dept. GMP certified pharmacy of PIA. Kashyapi care kit will be prepared in Pharmaceutical Unit of Parul Institute of Ayurveda following classical guidelines as mentioned in Sharangdhar Samhita and as per AFI*.*

Methods of collection of data : -          Study design:

·         An open label single arm clinical study among 30 primi or multiparous female who had  Full term normal delivery will be selected.

·         A special case proforma all the necessary details pertaining to the study will be   prepared.

·         Informed written consent will be obtain from all the subjects enrolled for the study.

 -          **Sample size :**·         Minimum of 30 subjects fulfilling the inclusion criteria irrespective of Primi and     Multipara will be selected.

  INCLUSION CRITERIA

•       Sutika aged between 20-35 years.

•       Primi or Multipara women with full term normal delivery (Beyond 37 weeks of gestation) who were willing to take part in the study and  ready to sign informed written consent form.

•       Delivered with or without Episiotomy.

EXCLUSION CRITERIA

•      Delivery with the Lower Segment caesarian Section.

•      Parturient with history of Eclampsia, APH, PPH, Gestational diabetes mellitus, IUD, Still birth.

•      Severe Anemia , less than 7gm/dl

Treatment duration:  7 Days

 Follow up – 12th day of treatment.

 Refrence – Kashyapa Samhita Khilsthan 11

   SOP for Udara & Bahya Yoni Abhyanga

Ø  PRE-OPERATIVE:

•       Counselling is done

•       Written consent is taken

•       Part preparation is done prior to procedure.

•       50 to 100ml of luke warm taila is taken in bowl.

•       Patient is advised to empty the bladder

Ø  OPERATIVE:

•       Patient is asked to empty the bladder and to lie in position on the examination table.

•       Private parts are cleaned antiseptically.

•       Luke warm medicine is taken in the gloved hand.

•       Abhyanga is done on the Abdomen, Vagina and then on the external genitalia.

 Ã˜  SAFETY PRECAUTIONS:

a. REGARDING MATERIALS:

•       Sterilisation of the instruments, linen is checked periodically.

b. REGARDING THE PATIENTS:

•       Part preparation is must to prevent the ascending infection.

•       Instruction is given to patient to avoid sexual intercourse, heavy work etc during and for 7days after the procedure.

c. REGARDING PROCEDURE:

•       Care is taken to ensure the procedure covers all the parts of vagina and the external genitalia.

 Ã˜  EMERGENCY MANAGEMENT:

•       Emergency conditions are very rare in Yoniabhyanga procedure. Still if happens patient has to inform the Investigator and get the suitable management.

 SOP For Yonidhoopan

Ø  PRE-OPERATIVE:

•       Counselling is done.

•       Written consent is taken.

•       Patient is advised to empty the bladder

Ø  OPERATIVE:

•       Patient is made to sleep in lithotomic position or in sitting position according to comfort of individual.

•       Clean the external genitalia along with the Episiotomy wound.

•       Dhoopana dravya is heated and fumes are made to touch the external genitalia episiotomy wound.

•       The procedure is done for 15minutes.

Ø  POST OPERATIVE:

•       Patient is monitored for 30minutes after the procedure.

 SAFETY PRECAUTIONS:

•       Periodie inspection is done to ensure the uniform exposure of fumes only on the genitalia.

•       Care is taken to prevent accidental burn which can be induced due to over exposure to fumes or accidental burn from the Doopana dravya.

 EMERGENCY MANAGEMENT:

•       There is no specific emergencies occuring due to the Doopana karma.

•       Still if happens patient has to inform the Investigator and get the suitable management.

 Purpose Of Study -

-          Proper restoration of body physiology is aim of Sutika paricharya.So Kashyapi care kit is designed as according to the versions of Acharya Kashyap to give a better and systematic nutrition in puerperal female in a short interval and to regain her energy.