| CTRI Number |
CTRI/2026/02/104372 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to evaluate the effect of Matulungadi Vati in reducing nausea and vomiting in pregnant women |
|
Scientific Title of Study
|
An Open Label Randomized Controlled Clinical Study To Evaluate The Effect Of Matulungadi Vati In Management Of Garbhini Chardi Vis-a-vis 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 Chinmayee P |
| Designation |
PG Scholor |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
Department of PG Studies in Stree Roga and Prasooti Tantra OPD 9 JSS Ayurveda Medical College and Hospital 41 E Lalithadripura road Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9945876894 |
| Fax |
|
| Email |
pmchinmayee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha DT |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
Department of PG Studies in Stree Roga and Prasooti Tantra OPD 9 JSS Ayurveda Medical College and Hospital 41 E Lalithadripura road Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9164455019 |
| Fax |
|
| Email |
Usha.ayurveda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha DT |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
Department of PG Studies in Stree Roga and Prasooti Tantra OPD 9 JSS Ayurveda Medical College and Hospital 41 E Lalithadripura road Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9164455019 |
| Fax |
|
| Email |
Usha.ayurveda@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Chinmayee P |
| Address |
JSS Ayurveda Medical College and Hospital 41E Lalithadripura road Mysuru |
| 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 Chinmayee P |
JSS Ayurveda Medical College and Hospital |
Department of PG Studies in Stree Roga & Prasooti Tantra, OPD NO. 9, JSS Ayurveda Medical College and Hospital 41E Lalithadripura road Mysuru
Mysore
KARNATAKA |
9945876894
pmchinmayee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: matulungadi vati, Reference: kashyap samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: jala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | tab Doxinate 20mg | Tab Doxinate common medicine prescribed during vomiting in pregnancy |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women aged 21 to 35 years
First trimester of pregnancy less than or equal to 12 weeks gestation
Symptoms of nausea and or vomiting not exceeding more than 5 episodes per day
Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Known Case Of Hyperemesis gravidarum
Known Case Of Systemic illness or endocrine disorders
Known Case Of Severe anemia less than 6g per dl Hepatic or Renal dysfunction
Known Case Of High Risk Pregnancy
Diagnosed Multiple gestation
Use of any antiemetic drugs in past 48 hours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity and frequency of nausea and vomiting in pregnant women assessed using visual analogue scale and PUQE 24 scoring system |
baseline day 0 and end of the treatment day 7 |
|
|
Secondary Outcome
|
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/03/2026 |
| 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
|
This study presents an open label randomized controlled clinical study to evaluate the efficacy and safety of Matulungadi vati in the management of Garbhini Chardi, which corresponds to nausea and vomiting of pregnancy. The study aims to compare the Ayurvedic formulation with Doxylamine Pyridoxine tablet in pregnant women during the first trimester. Garbhini Chardi is described in classical Ayurvedic texts as a complication of pregnancy caused mainly by aggravated Vata and Pitta and physiological changes due to the growing fetus. Modern medicine attributes nausea and vomiting of pregnancy to hormonal changes such as increased beta hCG and estrogen. Although conventional drugs are effective, they may cause side effects and reduce patient compliance, creating the need for safer alternatives. Matulungadi vati is prepared from Matulunga, Dadima, Laaja, Daruharidra and Sharkara, which possess antiemetic, digestive and soothing properties according to Ayurveda. Previous studies have evaluated similar individual drugs, but there is limited evidence on this specific combination in vati form. The study will include 60 pregnant women divided into two groups of 30 each. One group will receive Doxylamine Pyridoxine and the other will receive Matulungadi vati for seven days. Assessment will be based on nausea intensity, vomiting frequency, appetite, wellbeing, taste perception, sleep disturbance and patient satisfaction. Appropriate statistical tests will be applied to analyze the results. The study aims to provide scientific evidence for an effective, safe and patient friendly Ayurvedic intervention for the management of nausea and vomiting during early pregnancy. |