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CTRI Number  CTRI/2025/03/082641 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 07/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to evaluate the effect of Bilwadi Kwatha with Sharkara and Shunthi Bilwa Kwatha with Yava Saktu in Garbhini Chardi/ Hyperemesis Gravidarum. 
Scientific Title of Study   A randomised open-labelled comparative clinical study to evaluate the efficacy of Bilwadi Kwatha with Sharkara and Shunthi Bilwa Kwatha with Yava Saktu in the Management of Garbhini Chardi With special reference to Hyperemesis Gravidarum. 
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 Shivangi Sanghvi 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, UDayapura P.O, Bangalore-560082

Bangalore
KARNATAKA
560082
India 
Phone  07208845890  
Fax    
Email  shivangisanghvi03@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shubha Ural 
Designation  Associate Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, UDayapura P.O, Bangalore-560082

Bangalore
KARNATAKA
560082
India 
Phone  9945600058  
Fax    
Email  Shubha.ural@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivangi Sanghvi 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, UDayapura P.O, Bangalore-560082

Bangalore
KARNATAKA
560082
India 
Phone  07208845890  
Fax    
Email  shivangisanghvi03@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research hospital 21st km OB Chudahalli, Kanakapura road, Bengaluru 560082 
 
Primary Sponsor  
Name  Dr Shivangi Sanghvi 
Address  Sri Sri College of Ayurvedic Science and Research, Kanakapura Road, Udayapura P.O, 560082 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Sri Sri College of Ayurvedic Science and Research   Kanakapura road, Udayapura P.O, Bengaluru-560082  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivangi Sanghvi  Sri Sri College of Ayurvedic Science and Research  Department of Prasuti Tantra and Stree Roga, Room No.10, Sri Sri College of Ayurvedic Science and Research Hospital Kanakapura Road, Udayapura P.O, Bangalore-560082
Bangalore
KARNATAKA 
07208845890

shivangisanghvi03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Institutional Ethical Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O210||Mild hyperemesis gravidarum. Ayurveda Condition: GARBINYA VAMANAVYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Shunthi Bilwa Kwatha with Yava Saktu, Reference: Yogaratnakara , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Jala ), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Bilwadi Kwatha with Sharkara , Reference: SahasraYogam , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Based on ICD-11 Diagnosis Code JA60.0
1)Subjects between the age group of 18-45years.
2)Subjects with gestational age upto 22 weeks.
3)Both multigravida and primigravida.
4)Subjects with PUQE-24(Pregnancy Unique Quantification of Emesis)score upto 6.
5)Subjects with HELP(Hyper-Emesis Level Prediction)score upto 19.
6)Subjects with twin pregnancies and singleton.
7)Subjects diagnosed with symptoms of Garbhini Chardi.
8)Subjects with mild hypoglycemia, mild huponatremia, mild dehydration as per scale.
9)Subjects willing to sign the consent form. 
 
ExclusionCriteria 
Details  1)Subject with PUQE score more than or equal to 7 to 15.
2)Subjects with HELP score more than or equal to 20 to 60.
3)Subjects with molar pregnancy and other systemic illness like cardiac diseases, TB, etc.
4)Subjects with Diabetes Mellitus.
5)Subjects with Psychiatric illness.
6)Subjects with moderate to severe hypoglycemia, moderate to severe hyponatremia, moderate to severe dehydration as per scale.
7)Subjects with vomiting in pregnancy due to medical causes, surgical causes, gynecological causes.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)The efficacy of Bilwadi Kwatha with Sharkara and Shunthi Bilwa Kwatha with Yava Saktu will be established in the treatment of Garbhini Chardi with special reference to Hyperemesis Gravidarum.
2)Significant decrease in the symptoms of Garbhini Chardi with special reference to Hyperemesis Gravidarum assessed based on PUQE score, HELP score and other subjective and objective parameters. 
treatment period - 14 days
study duration - 21 days  
 
Secondary Outcome  
Outcome  TimePoints 
1)To do literary review on Garbhini Chardi, Hyperemesis Gravidarum.   1 year 
 
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 2/ Phase 3 
Date of First Enrollment (India)   01/04/2025 
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 Yet Recruiting 
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  

                 Maternal physiology during pregnancy phase is under continuous adaptation. Various physiological and psychological changes take place during pregnancy. Garbhini Chardi is one of the changes taking place in pregnancy and Ayurvedic classics have mentioned Garbhini Chardi as one among the Vyakta Garbha Lakshsana[1,2,3]. Chardi is seen as a Vyakta Garbha Lakshana and is considered as physiological condition when it is not associated with any deleterious effect on mother and it becomes pathological condition, when it causes deleterious effect on mother i.e.Hyperemesis Gravidarum. Hyperemesis Gravidarum is a condition causing severe nausea and vomiting in early pregnancy which may sometimes require hospitalization.[4]

                  According to previous work done, the prevalence of Hyperemesis Gravidarum is 1.66% [5]. Proper consumption of nutrients is very essential for the growth of fetus and well being of mother in early pregnancy, but due to intense nauseatic feeling, mother cannot take sufficient quantity of nutrients and it may cause dehydration, tiredness, weight loss which may affect the growth of fetus. In classics Acharyas have mentioned that Garbhini  should be taken care like a pot filled with oil, as Garbhini Avastha is termed as delicate state, the Aushadis which are been given to her must have Sukh Sukumara properties[6]. Antiemetic drugs from contemporary medicine lack to have nutritive, appetizer properties in it.

                  In Yogaratnakara, individual drugs like Bilwa, Shunthi, Dhanayaka, Laja, Yava Saktu are mentioned in Chikitsa of Garbhini Chardi[7]. In Kashyapa Samhita, Mudga is mentioned in Chikitsa of Garbhini Chardi[8]. Antiemetic drugs from contemporary medicine lack to have nutritive, appetizer properties in it. In Yogaratnakara, individual drugs like Bilwa, Shunthi, Dhanayaka, Laja, Yava Saktu are mentioned in Chikitsa of Garbhini Chardi[7]. In Kashyapa Samhita, Mudga is mentioned in Chikitsa of Garbhini Chardi[8]. In Charaka Samhita, Bala is mentioned as a Prajasthapana Gana.[9]

                  A single formulation containing all these Dravyas is mentioned in Sahasrayogam and Yogaratnakara as well as these reference are present in Quality Control and Standardisation of Ayurvedic Medicine[10].

                  Bilwadi Kwatha with Sharkara has properties like Deepana, Pachana, Rochana, Hridya, Chardihara, Dahaprashamana, Tarpana, Kapha-Vatahara as well as it has vitamin B-complex in it[11].

                  Shunthi Bilwa Kwatha with Yava Saktu has properties like Ruchivardhaka, Agnideepaka, Amapachaka and has carbohydrate which is easy for assimilation[12].

                  Since both the Yogas are in Kwatha form, easy to prepare, safe in pregnancy, acts as Chardi-hara and so this comparative study has been considered for the research work. 

        Null Hypothesis (H0): There is no significant difference between effect of Bilwadi Kwatha with Sharkara and Shunthi Bilwa Kwatha with Yava Saktu in the management of Garbhini Chardi with special reference to Hyperemesis Gravidarum.

        Alternative Hypothesis (H1): There is significant effect of Bilwadi Kwatha with Sharkara when compared to Shunthi Bilwa Kwatha with Yava Saktu in the management of Garbhini Chardi with special reference to Hyperemesis Gravidarum.

        Alternative Hypothesis (H2): There is significant effect of Shunthi Bilwa Kwatha with Yava Saktu when compared to Bilwadi Kwatha with Sharkara in the management of Garbhini Chardi with special reference to Hyperemesis Gravidarum.

 
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