| CTRI Number |
CTRI/2026/01/101868 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Sharkarayukta Bhunimba kalka and tab doxinate in Garbhini Chardi |
|
Scientific Title of Study
|
An Open Randomised Controlled Clinical Trial to evaluate the efficacy of Sharkarayukta Bhunimba kalka in 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 SANGEETA SAVALARAM CHAUDHARY |
| Designation |
PG Scholar |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College and Hospital |
| Address |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College and Hospital, 3rd floor, Gynaec Dept, Sector-4, Kharghar, Navi Mumbai,Raigarh
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9021855959 |
| Fax |
|
| Email |
sangeetachaudhary275@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRANALI DANDEKAR |
| Designation |
Associate Professor, PG Guide,MD(Ayu) |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College and Hospital |
| Address |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College and Hospital, 3rd floor, Gynaec Dept, Sector-4, Kharghar, Navi Mumbai,Raigarh
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9619020010 |
| Fax |
|
| Email |
pranalibhardwaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANGEETA SAVALARAM CHAUDHARY |
| Designation |
PG Scholar |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College and Hospital |
| Address |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College and Hospital, 3rd floor, Gynaec Dept, Sector-4, Kharghar, Navi Mumbai,Raigarh
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9021855959 |
| Fax |
|
| Email |
sangeetachaudhary275@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR G D POL FOUNDATION,YMT Ayurvedic Medical College And Hospital, Sector-4,Kharghar,Navi Mumbai,Maharashtra 410210,India |
|
|
Primary Sponsor
|
| Name |
Dr Sangeeta Savalaram Chaudhary |
| Address |
Dr G D POL FOUNDATION,YMT Ayurvedic Medical College and Hospital,3rd Floor,Gynaec Dept,Sector-4,Kharghar,Navi Mumbai,Maharashtra 410210,India |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sangeeta Savalaram Chaudhary |
Dr G D Pol Foundation YMT Ayurvedic Medical College and Hospital |
3rd Floor, Gynaec Dept, Sector-4, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA |
9021855959
sangeetachaudhary275@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr G D Pol Foundation YMT Ayurvedic Medical College and charitable hospital,Kharghar,Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O219||Vomiting of pregnancy, unspecified. Ayurveda Condition: GARBINYA VAMANAVYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sharkarayukta Bhunimba Kalka, Reference: Harita Samhita Trutiya Sthana 51/6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Doxinate | Tab Doxinate ( doxylamine succinate 10mg and pyridoxine 10mg) orally,for 7 days,empty stomach OD |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. ANC having Garbhini Chardi in first trimester of pregnancy of any gravida
2. ANC Patients having Normal ANC profile |
|
| ExclusionCriteria |
| Details |
1. Garbhini having hyper emesis gravidarum
2. Garbhini with severe infection like TORCH,etc
3. Garbhini with systemic disorders like DM,Hypertension,etc
4. Garbhini on other medication causing nausea and vomiting |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Sharkarayukta Bhunimba Kalka in management of Garbhini Chardi with special reference to Emesis Gravidarum |
1st visit- Baseline
2nd visit- 3rd day
3rd visit-7th day
4th visit-15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study & review literatue on Garbhini Chardi & emesis gravidarum |
1st visit- Baseline
2nd visit- 3rd day
3rd visit-7th day
4th visit-15th day |
|
|
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 1 |
|
Date of First Enrollment (India)
|
03/02/2026 |
| 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
|
The Present Study is a PG Thesis Topic By PG Scholar - DR SANGEETA SAVALARAM CHAUDHARY and Guide Nmae - DR PRANALI DANDEKAR Title - AN OPEN RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SHARKARAYUKTA BHUNIMBA KALKA IN GARBHINI CHARDI w.s.r.t EMESIS GRAVIDARUM
According to inclusion and exclusion criteria Group A 40 patients and Group B 40 patients will be selected Group A ( intervention ) will be given sharkarayukta bhunimba kalka 12gm muhurmuhu QID for 7 days Group B (control/comparative) will be given Tab Doxinate 10mg empty stomach OD for 7 days
Total Duration of study is 1 year 6 months |