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CTRI Number  CTRI/2025/08/092203 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of guduchi ghanavati in vomitting in pregnancy  
Scientific Title of Study   Randomised controlled clinical trial to evaluate the efficacy of guduchi ghanavati in the management of garbhini chardi with special reference to emesis 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 Aashitosh Suresh Desai 
Designation  PG Scholar 
Affiliation  Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal nagar Hirawadi Panchavati Nashik 
Address  Department of prasutitantra and striroga OPD no 4 ground floor Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamalnagar Hirawadi Panchavati Nashik
Nashik
Nashik
MAHARASHTRA
422003
India 
Phone  9049417423  
Fax    
Email  ashitoshdesai1024@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunil Sadashiv More 
Designation  HOD and Professor 
Affiliation  Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal nagar Hirawadi Panchavati Nashik 
Address  More Niwas behind KK Wagh Engineering College Panchavati Nashik
Nashik
Nashik
MAHARASHTRA
422003
India 
Phone  9423934505  
Fax    
Email  moresunil263@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sunil Sadashiv More 
Designation  HOD and Professor 
Affiliation  Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal nagar Hirawadi Panchavati Nashik 
Address  More Niwas behind KK Wagh Engineering College Panchavati Nashik
Nashik
Nashik
MAHARASHTRA
422003
India 
Phone  9423934505  
Fax    
Email  moresunil263@gmail.com  
 
Source of Monetary or Material Support  
Shree Saptashrungi Ayurveda Mahavidyalaya and Hospital Kamalnagar Hirawadi Panchavati Nashik 422003 
 
Primary Sponsor  
Name  Dr Aashitosh Suresh Desai 
Address  Department of prasutitantra and striroga OPD no 4 ground floor Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamalnagar Hirawadi Panchavati Nashik Maharashtra India 422003 
Type of Sponsor  Other [Self] 
 
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 Aashitosh Suresh Desai  Shree Saptashrungi Ayurved Mahavidyalaya And Hospital Nashik  Department of Prasutitantra And Striroga OPD no 4 Ground Floor Shree Saptashrungi Ayurved Mahavidyalaya And Hospital Kamalnagar Hirawadi Panchavati Nashik 422003
Nashik
MAHARASHTRA 		 9049417423

ashitoshdesai1024@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamalnagar Hirawadi Panchavati Nashik  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: GARBINIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Guduchi, Reference: Bhavprakash Nighanthu Adhyay 3 Shloka no 06 to 10 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Ingestion of Guduchi Ghanavati in Garbhini Chardi
2Comparator Arm (Non Ayurveda)-Doxylamine succinateIngestion of Doxylamine succinate 40 mg 1BD before food for 14 days in Garbhini Chardi
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Patients between 21 to 35 years of age
Patients diagnosed as garbhini chardi in first trimester of pregnancy
Patients with Hb more than 8 gm per dl
 
 
ExclusionCriteria 
Details  Pregnancy with convulsive disorder and fetal anomalies
Pregnant women suffering from communicable disease hypertension cardio vascular disease asthma severe gastrointestinal infections tuberculosis and serological disorders
Pregnant women suffering from multiple pregnancy ectopic pregnancy
Gynecological conditions like fibroids torsion of ovarian cyst and septic abortion with peritonitis
Uncooperative pregnant patients
Severe anemia
Pregnancy cholestasis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Symptomatic relief of Garbhini Chardi within 1 week of treatment  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Complete relief of garbhini chardi within 14 days  14 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 
Date of First Enrollment (India)   01/08/2025 
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 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  
Randomised controlled clinical trial to evaluate the efficacy of guduchi ghanavati in the management of garbhini chardi with special reference to emesis gravidarum

Primary objective
To compare effect of guduchi ghanavati in garbhini chardi on comparison with doxylamine succinate

Secondary objective
To study the efficacy of guduchi ghanavati in garbhini chardi with special reference to emesis gravidarum 
To study the disease garbhini chardi according to ayurveda and modern science 
Literary review regarding guduchi

Patients will be divided in two groups
Group A and Group B and will be given guduchi ghanavati 
and doxylamine succinate respectively for 14 days
Clinical assessment will be done on day 1 day 5 day 7 day 14 

Inclusion criteria
Patients between 21 to 35 years of age
Patients diagnosed as garbhini chardi in first trimester of pregnancy 
Patients with HB more than 8 gm per dl

Exclusion criteria
Pregnancy with convulsive disorder and fetal anomalies
Pregnant women suffering from communicable disease hypertension cardiovascular disease asthma severe gastrointestinal infections tuberculosis and serological disorder
Pregnant women suffering from multiple pregnancy ectopic pregnancy
Gynecological conditions like fibroids torsion of ovarian cyst and septic abortion with peritonitis
Uncooperative pregnant patients
Severe anemia
Pregnancy cholestasis
Withdrawal criteria
If found adverse effect or reaction 
Patient not completing duration of treatment 
Occurrence of any other disease during treatment 

Primary outcome
Symptomatic relief of garbhini chardi within 7 days of start of treatment 

Secondary outcome
Complete relief of garbhini chardi within 14 days of treatment 
All data will be collected from clinical case studies will be presented in the form of graph charts grade 
Patients will be observed before and after treatment
All observed data collected after the final assessment will be subjected to statistical analysis
 
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