| CTRI Number |
CTRI/2026/02/104185 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic management of vomiting in pregnancy (Garbhini chardi) with bhrushtamudgavati |
|
Scientific Title of Study
|
An open label randomized controled trial to study the efficacy of Bhrushtamudga vati and Eladi vati in the management of Garbhini Chardi w.s.r 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 Jadhav Akshay Vitthal |
| Designation |
PG Scholar |
| Affiliation |
Shree jagadguru gavisiddeshwara ayurvedic medical college and Hospital koppal |
| Address |
OPD 17,Dept of prasooti tantra and stree roga shree jagadguru gavisiddheshwara ayurvedic medical college and hospital koppal 583231 karnataka
Koppal KARNATAKA 583231 India |
| Phone |
7758986677 |
| Fax |
|
| Email |
akshayjadhav17199@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sreeja V |
| Designation |
HOD & Professor |
| Affiliation |
Shree jagadguru gavisiddeshwara ayurvedic medical college and Hospital koppal |
| Address |
OPD 17,Dept of prasooti tantra and stree roga shree jagadguru gavisiddheshwara ayurvedic medical college and hospital koppal 583231 karnataka
Koppal KARNATAKA 583231 India |
| Phone |
8971432678 |
| Fax |
|
| Email |
dr.sreejarun@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sreeja V |
| Designation |
HOD & Professor |
| Affiliation |
Shree jagadguru gavisiddeshwara ayurvedic medical college and Hospital koppal |
| Address |
OPD 17,Dept of prasooti tantra and stree roga shree jagadguru gavisiddheshwara ayurvedic medical college and hospital koppal 583231 karnataka
Koppal KARNATAKA 583231 India |
| Phone |
8971432678 |
| Fax |
|
| Email |
dr.sreejarun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree jagadguru gavisiddheshwara ayurvedic medical college and hospital koppal 583231 karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Jadhav Akshay Vitthal |
| Address |
Sheee jagadguru gavisiddhshara ayurvedic medical college and hospital koppal karnataka |
| 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 Jadhav Akshay Vitthal |
Shree jagadguru gavisiddheshwara ayurvedic medical college |
OPD No 17, Department of prasuti tantra and shee roga, Sheee jagadguru gavisiddhshara ayurvedic medical college and hospital koppal karnataka Koppal KARNATAKA |
7758986677
akshayjadhav17199@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,SJGAMC,koppal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O210||Mild hyperemesis gravidarum. Ayurveda Condition: CARDIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: ELADI VATI, Reference: Bhaishajya Ratnavali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: sukoshna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhrushtamudga vati, Reference: Chakradatt, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: sukoshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Subjects of age group 20-30 years with Primi or Multi Gravida diagnosed with Garbhini Chardi Emesis Gravidarum in first trimester of pregnancy will be included. |
|
| ExclusionCriteria |
| Details |
Garbhini with Hyperemesis Gravidarum.
Garbhini having H/O of other systemic illness like Colonic Obstruction, Urinary tract infection, Renal Calculi, Anemia, Jaundice, Psychiatric illness, Enteric infection. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decreases the incidences of Chardi |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
decreasing the Utklesha of Doshas & has a soothing effect & it ease the pregnancy
decreases the incidences of Chardi |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
28/02/2026 |
| 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="2" Days="10" |
|
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
|
In a women’s life, pregnancy is a unique, exciting and joyous time as it highlights her amazing creative and nurturing power. The growing foetus depends entirely on the mother’s body for all its requirements of growth and development. So, pregnant women should adopt measures to be healthy and well-nourished to have a healthy child1. To meet these requirements the maternal internal system undergoes certain changes to make conditions favourable to the growing fetus. As a result, multiple physiological changes take place, one among them Garbhini Chardi (Emesis Gravidarum). Nausea and vomiting in pregnancy (NVP) are a common condition that affects up to 50percentage of pregnant women. NVP is common and usually begins at early pregnancy and generally resolves by 12-14 weeks. Garbhini chardi is mentioned one among the Vyakta Garbha Lakshana along with other Lakshanas such as ArtavaAdarshana, Arochaka, Gurugatrata, Stanamandalakrushnata these Lakshanas are found in Garbhini due to the presence of Garbha. According to Ayurvedic classics Nidana of Garbhini Chardi is said to be due to Vatavaigunya, Dauhrudaavastha and Garbhanimitta. while explaining the Chikitsa of Garbhini Chardi Acharyas have mentioned that the Garbhini should be given things that are easily palatable and Hrudya. When Chardi is seen as a physiological manifestation of pregnancy, there is no adverse effect on the growing fetus and mother. But when it turns to be pathological it requires early intervention to prevent severe dehydration, tiredness, weight loss which can leads to complications like ketoacidosis, stress ulcers in stomach, jaundice in mother; which may lead to fetal malnourishment. If Garbhini Chardi is not managed properly it may lead to Garbhapata ( Miscarriage ) , Kshaya ( Emaciation) ,Daurbalya (Weakness),& disturbances in fetal growth & development3 .Thus, there is a need to treat such condition as early and relieve the patient symptomatically. Hence the present study is undertaken to evaluate the effect of Bhrushtamudga vati8 and Eladi vati in the management of Garbhini Chardi w.s.r. emesis gravidarum. Bhrushtamudga vati has actions like Deepan, Pachana and Stambhana6 which decreases the incidences of Chardi. Mudga performs Kaphapittashamak activity as well as helps in decreasing the Utklesha of Doshas and has a soothing effect. It is Balya in nature and thus performs Tarpana which helps in correction of Upadravas. |