| CTRI Number |
CTRI/2025/09/094512 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between sunthi bilva kwatha with yava saktu and Doxylamine succinate tablet in Garbhini Chhardi |
|
Scientific Title of Study
|
Standard Control Clinical Evaluation Of Sunthi Bilva Kwatha With Yava Saktu In Garbhini Chhardi (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 |
Nirmala mehta |
| Designation |
P.G scholar (Prasuti Tantra) |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University |
| Address |
O.P.D No.09,Department of Prasuti Tantra, Rishikul
Campus, Haridwar, Uttarakhand Ayurved University (Dehradun)
Haridwar
UTTARANCHAL
249401
India
PG Department of Prasuti Tantra Evum Stree Roga, Rishikul Campus, Haridwar
Uttrakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8791488566 |
| Fax |
|
| Email |
neeru.7mehta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nirmala mehta |
| Designation |
P.G scholar (Prasuti tantra) |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University |
| Address |
O.P.D No.09,Department of Prasuti Tantra, Rishikul
Campus, Haridwar, Uttarakhand Ayurved University (Dehradun)
Haridwar
UTTARANCHAL
249401
India
PG Department of Prasuti Tantra Evum Stree Roga, Rishikul Campus, Haridwar
Uttrakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8791488566 |
| Fax |
|
| Email |
neeru.7mehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hem Prakash |
| Designation |
Assistant Professor (Prasuti tantra) |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University |
| Address |
O.P.D No.09,Department of Prasuti Tantra, Rishikul
Campus, Haridwar, Uttarakhand Ayurved University (Dehradun)
Haridwar
UTTARANCHAL
249401
India
PG Department of Prasuti Tantra Evum Stree Roga, Rishikul Campus, Haridwar
Uttrakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7906210931 |
| Fax |
|
| Email |
hemprakash78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, Haridwar Uttarakhand Ayurved University (Dehradun) |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University Dehradun |
| Address |
Uttarakhand Ayurved University Station Road Harrawala
Dehradun Uttarakhand
Pin-248001
India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrNirmala mehta |
Rishikul Ayurvedic Hospital, Haridwar |
O.P.D No 09, P.G.
Department of
Prasuti Tantra,
Rishikul Campus,
Haridwar, Uttarakhand
Ayurved University
(Dehradun)
Haridwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
8791488566
neeru.7mehta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE UTTARAKHAND AYURVED UNIVERSITY |
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: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Doxylamine Succinate | Dose 10Mg Bd For 15 days Taken On Empty Stomach | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sunthi Bilva Kwath With Yava Saktu, Reference: Yog Rattnakar Stree Roga Chikista/9, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Yava Saktu ), Additional Information: Dose Rages From 20-40 Ml Bd According To Patient Prakriti(2) Medicine Name: Sunthi Bilva kwatha With Yavasaktu , Reference: Yog Rattnakar Stree Roga Chikista/9, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Yava Saktu ), Additional Information: Dose Rages From 20-40 Ml Bd According To Patient Prakriti |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women of age between 20 to 35 years.
2. All patients diagnosed with Garbhini Chhardi in first trimester of pregnancy irrespective of parity and religion |
|
| ExclusionCriteria |
| Details |
1. Patients in whom vomiting is seen in second and third trimester of pregnancy.
2. Patients with hyper Emesis Gravidarum or weight loss more than 4.5kg subsequent visits.
3. Patient with twin‘s pregnancy, ectopic pregnancy, vesicular mole.etc
4. Pregnant women with diabetes mellitus, HIV, Hepatitis B, Hepatitis C, hypertension, uraemia,jaundice etc
5. Vomiting caused due to other systemic disorders like GI disorder
(Peptic ulcer, intestinal obstruction,UTI, worm infestation )etc.Nervous disorder (migraine motion sickness) etc.cardiovascular system disorder System like Acute myocardial infarction (MI) & congestive heart failure(CHF) etc
6.Patients in whom vomitus is coffee brown in colour or mixed with blood |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Standard Control Clinical Evaluation Of Sunthi Bilva Kwatha With Yava Saktu In Garbhini Chhardi(Emesis Gravidarum)Subjectively All Sign And Symptoms Are Given With Grading Depending Upon Their Severity |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| STANDARD CONTROL CLINICAL EVALUATION OF SHUNTHI BILVA KWATHA WITH YAVA SAKTU IN GARBHINI CHHARDI (EMESIS GRAVIDARUM)’’SUBJECTIVELY ALL SIGN AND SYMPTOMS ARE GIVEN WITH GRADING DEPENDING UPON THEIR SEVERITY. |
FIFTEEN DAYS |
| Standard Control Clinical Evaluation Of Sunthi Bilva Kwatha With Yava Saktu In Garbhini Chhardi(Emesis Gravidarum)Subjectively All Sign And Symptoms Are Given With Grading Depending Upon Their Severity |
Fifteen days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/09/2025 |
| 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
|
THIS STUDY IS STANDARD CONTROL CLINICAL EVALUATION OF SHUNTHI BILVA KWATHA WITH YAVA SAKTU IN GARBHINI CHHARDI (EMESIS GRAVIDARUM)’’ THIS STUDY WILL BE CONDUCTED ON 60 RANDOMLY SELECTED PATIENTS FROM OPD/ IPD OF PRASUTI TANTRA DEPARTMENT OF RISHIKUL AYURVEDIC HOSPITAL, RISHIKUL CAMPUS HARIDWAR, UTTARAKHAND AYURVED UNIVERSITY. AND GOVERNMENT CHAINNARAI WOMEN HOSPITALS HARIDWAR PATIENTS WILL BE DIVIDED INTO 2 GROUPS-30 PATIENTS WILL BE ADMINISTERED SHUNTHI BILVA KWATHA WITH YAVA SAKTU DOSE IS 20-40 ML BD FOR 15 DAYS & 30 PATIENTS WILL BE ADMINISTERED - DOXYLAMINE SUCCINATE TABLETS-10MG BD FOR 15 DAYS TOTAL 4 FOLLOW UPS -2 ASSESSMENT IN BETWEEN THE TREATMENT ON 7TH DAY IN EACH MONTH AND 4TH FOLLOW UPS AFTER THE TREATMENT TOTAL TREATMENT ASSESMENT WILL BE DONE ON THE BASIS OF SUBJECTIVE & OBJECTIVE PARAMETERS AS DISCUSSED EARLIER |