| CTRI Number |
CTRI/2025/10/096180 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Shunti bilwa kashaya and tab doxinate effect in Garbhini Chardi |
|
Scientific Title of Study
|
A Randomised Controlled Trial To Evaluate The Efficacy Of Shunthi-Bilwa Kashaya In Garbhini Chardi W.S.R.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 YOGITA KAMLESH YADAV |
| 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
MAHARASHTRA
410210
India |
| Phone |
8830129423 |
| Fax |
|
| Email |
yogitayadav121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JENY BHATT |
| Designation |
Assistany Professor, PG Guide, PhD (Sch) |
| 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
MAHARASHTRA
410210
India |
| Phone |
9167541086 |
| Fax |
|
| Email |
dr.jenybhatt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR YOGITA KAMLESH YADAV |
| Designation |
PG Scholar |
| Affiliation |
|
| Address |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital, 3rd Floor, Gynaec Dept, Sector- 4, Kharghar , Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8830129423 |
| Fax |
|
| Email |
yogitayadav121@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital, Sector- 4, Kharghar , Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Yogita Kamlesh Yadav |
| Address |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital, 3rd Floor, Gynaec Dept, Sector- 4, Kharghar , Navi Mumbai |
| 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 Yogita Kmalesh Yadav |
Dr GD Pol Foundation YMT Ayurvedic Medical College and Hospital |
3rd Floor, Gynaec Dept, Sector- 4, Kharghar , Navi Mumbai
Raigarh
MAHARASHTRA |
8830129423
yogitayadav121@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 |
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: shunthi bilwa kashaya, Reference: yogratnakar stree roga 9/11, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Abhakta, 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 Pregnant females diagnosed as garbhini chardi in first trimester of pregnancy of any gravida
2 ANC profile already done by patient |
|
| ExclusionCriteria |
| Details |
1 Hyperemesis Gravidarum
2 Pregnant woman suffering from severe infections such as TORCH etc
3 Pregnant woman suffering from systemic disorders such as DM HTN THYROID etc
4 Pregnant woman on other medications such as Antibiotics Antifungal etc |
|
|
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 and Compare the Efficacy of Shunthi-Bilwa Kashaya and Tablet Doxinate in Garbhini Chardi w.s.r.t. Emesis Gravidarum. |
1st Visit - Baseline
2nd Visit - 3rd day
3rd Visit - 7th day
4th Visit 15th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Study the Complete Literature on Garbhini Chardi & Emesis Gravidarum available in Texts.
|
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
|
N/A |
|
Date of First Enrollment (India)
|
28/10/2025 |
| 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
|
The Present Study is a PG Thesis Topic By PG Scholar - DR YOGITA KAMLESH YADAV and Guide Name - DR JENY MUKESH BHATT
Title - A RANDOMISED CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF SHUNTHI BILWA KASHAYA 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 shunthi bilwa kashaya 100ml empty stomach OD 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. |