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CTRI Number  CTRI/2024/05/066748 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Udarmardana, Udarswedana, Bahya Yonisnehana, Yonidhoopan]  
Study Design  Single Arm Study 
Public Title of Study   To Study The Effect Of Kashyapi Care Kit in Sutika (Postnatal Period) 
Scientific Title of Study   A Clinical Study To Evaluate The Efficacy Of Kashyapi Care Kit In The Management Of Sutika Paricharya W.S.R. To Postpartum Care. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Princy Patel 
Designation  PG Scholar 
Affiliation  Parul Institute Of Ayurved 
Address  Room No. 309, Department of PG Studies in Prasuti Tantra Evum Stree Roga, Parul Institute Of Ayurved, Parul University, Limda, Waghodia, Vadodara, Gujarat.

Vadodara
GUJARAT
391760
India 
Phone  7698356323  
Fax    
Email  patelprincy722@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rita Makim 
Designation  Professor 
Affiliation  Parul Institute Of Ayurved 
Address  Room No. 309, Department of PG Studies in Prasuti Tantra Evum Stree Roga, Parul Institute Of Ayurved, Parul University, Limda, Waghodia, Vadodara, Gujarat.

Vadodara
GUJARAT
391760
India 
Phone  7990727524  
Fax    
Email  ritamakim@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rita Makim 
Designation  Professor 
Affiliation  Parul Institute Of Ayurved 
Address  Room No. 309, Department of PG Studies in Prasuti Tantra Evum Stree Roga, Parul Institute Of Ayurved, Parul University, Limda, Waghodia, Vadodara, Gujarat.

Vadodara
GUJARAT
391760
India 
Phone  7990727524  
Fax    
Email  ritamakim@gmail.com  
 
Source of Monetary or Material Support  
Parul Ayurved Hospital, Parul University, Vadodara - 391760, Gujarat. 
 
Primary Sponsor  
Name  Parul Institute Of Ayurved 
Address  Room No. 309, Department of PG Studies in Prasuti Tantra Evum Stree Roga, Parul Institute Of Ayurved, Parul University, Limda, Waghodia, Vadodara, Gujarat. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Princy Patel  Parul Ayurved Hospital  OPD No 104, Stri Roga Evum Prasuti Tantra OPD, Parul Ayurved Hospital, Parul University, PO Limda, Tal Waghodia, Vadodara 391760
Vadodara
GUJARAT 
7698356323

patelprincy722@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Parul Institute Of Ayurved, Parul University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O80||Encounter for full-term uncomplicated delivery. Ayurveda Condition: SUTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Sutika Dashamoola , Reference: Bhaishajya Ratnavali Sutika Chikitsa , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Pippali, Sunthi , Reference: Kashyap Samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Days, anupAna/sahapAna: No, Additional Information: -with Snehayukta Yavagu
2Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Kashyap Samhita , Procedure details: Purva Karma - Take Consent for the procedure & Ask the patient to Empty the bladder & lie in the Supine position. Bala taila is made warm which is comfortable to patient. Pradhan Karma - Abhyanga will be started from the umbilicus. Lukewarm oil is applied to whole abdomen. The oil applied uniformly & will be massaged in circular manner. Pashchat Karma - Patient should take complete rest in comfortable position. Proper Swedana should be done immediately after Abhyanga before warm water bath)
(1) Medicine Name: Bala Taila, Reference: Bhaishajya Ratnavali , Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 3 Days
3Intervention ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: Kashyap Samhita , Procedure details: Udar Swedana done with hot water immediately after udarmardana for 3 days)
4Intervention ArmProcedure-dhUpana, धूपन (Procedure Reference: Kashyap Samhita , Procedure details: Purva Karma - Ask the patient to Empty the bladder & lie in the lithotomy position. Prepare part & Painting. Bahya Yoniprakshalana with warm water. With a sterile gauze piece, the vagina will be cleaned. Bahya yoni snehan done with Luke warm Bala taila. Pradhana karma: - Yonidhupana will be done for a specific duration of time. Pashchat Karma - Patient should take complete rest in comfortable position. Procedure Duration - for 3 days)
(1) Medicine Name: Guggulu, Aguru, Kushtha , Reference: Kashyap Samhita , Route: Vaginal, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Duration: 3 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  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.
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduces the Postpartum Complications.
Increases the quality of life. 
7 days Medicine with 3 days procedures.
Follow up On 12th day of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Overall health of Postpartum Women  7 days Medicine with 3 days procedures.
Follow up On 12th day of treatment 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 Kashyapi Care Kit 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.

 

Ø  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.

 

Ø  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.

 

 
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