| CTRI Number |
CTRI/2026/02/103524 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare effect of bhunimba sharkara vati and bilvamajja vati in the management of vomiting in pregnancy (garbhini chardi) in first three months of pregnancy. |
|
Scientific Title of Study
|
A randomised clinical comparative study of bhunimba sharkara vati and bilvamajja vati in the management of garbhini chardi in first trimester 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 |
Vd Veena Ramesh Kelamangalath |
| Designation |
PG Scholar Third Year Striroga And Prasutitantra |
| Affiliation |
Ashvin Rural Ayurved College And Hospital |
| Address |
Striroga and Prasutitantra Department,Ashvin Rural Ayurved College And Hospital,Sadvi Preetisudhaji Maharaj Nagar,Manchi Hill,Ashvi Bk,Tal Sangamner,Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9860803532 |
| Fax |
|
| Email |
veenaramesh1604@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd .Vidya Sarode |
| Designation |
HOD |
| Affiliation |
Ashvin Rural Ayurved College And Hospital |
| Address |
Striroga and Prasutitantra Department,Ashvin Rural Ayurved College And Hospital,Sadvi Preetisudhaji Maharaj Nagar,Manchi Hill,Ashvi Bk,Tal Sangamner,Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
8975019105 |
| Fax |
|
| Email |
vidya.sarode18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Veena Ramesh Kelamangalath |
| Designation |
PG Scholar Third Year Striroga And Prasutitantra |
| Affiliation |
Ashvin Rural Ayurved College And Hospital |
| Address |
Striroga and Prasutitantra Department,Ashvin Rural Ayurved College And Hospital,Sadvi Preetisudhaji Maharaj Nagar,Manchi Hill,Ashvi Bk,Tal Sangamner,Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9860803532 |
| Fax |
|
| Email |
veenaramesh1604@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vd Veena Ramesh Kelamangalath |
| Address |
Ashvi Rural Ayurved College And Hospital,Sadvi Preetisudhaji Maharaj Nagar ,Manchi Hill,Ashvi Bk,Tal Sangamner,Dist Ahmadnagar,Pin 413714 |
| 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 |
| Vd Veena Ramesh Kelamangalath |
Ashvi Rural Ayurved College And Hospital |
Striroga and Prasutitantra Department,Ashvin Rural Ayurved College And Hospital,Sadvi Preetisudhaji Maharaj Nagar,Manchi Hill,Ashvi Bk,Tal Sangamner,Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA |
09860803532
veenaramesh1604@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashvin Rural Ayurved Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O210||Mild hyperemesis gravidarum. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhunimba Sharkara Vati, Reference: Haarit Samhita,Trutiya Khand,Adhyaay 51,Shlok 6, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bilvamajja Vati, Reference: Yog Ratnakar Strirogadhikar Chikitsasthaan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Lajambu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients with pregnancy between 18-35 years of age.
All pregnant woman with chardi vega in 1st trimester of pregnancy.
Primi gravida with 4- 5 episodes ofvomiting.
Patients willing for drug administration.
|
|
| ExclusionCriteria |
| Details |
Patients with hyperemesis gravidarum (more than 5 episodes of vomiting with dehydration)
Patients in whom chardi is seen in 2nd and 3rd trimester of pregnancy.
Vomiting in pregnancy associated with systemic disorders like hyperacidity, peptic disorders, hepatitis.
Patients of multiple pregnancy, gestational trophoblastic disease, hydatiform mole.
A known case of HIV, TB ,Thyroid and DM.
Patients with complications like severe dehydration,keto acidosis.
Patients with blood pressure less than 100/70 mm Hg.
|
|
|
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 |
| To compare the effect of Bhunimba Sharkara vati and Bilvamajja vati in the management of garbhini chardi in first trimester w.s.r. to emesis gravidarum |
On 4th,7th,11th,15th day after drug administration |
|
|
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)
|
20/02/2026 |
| 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
|
Pregnancy is delicate
with many physical and hormonal changes in woman as the growing fetus depends
entirely on the mother. Women are considered as one of the most essential factor
for continuity of race.Pregnancy though a natural process,can have
complications at any stage due to changes in a pregnant woman’s body anatomy
and physiology.So during these nine months of pregnancy ,a woman has to undergo
a number of physical, emotional, physiological changes which alter her day to
day activities. One of these changes is Garbhini Chardi.
This symptom remains
severe for first three to four months and later it becomes milder and vanishes
completely by the end of second month.Due to non fulfillment of dauhrida and
presence of fetus, vata gets provoked and causes vomiting.Physiological changes
which are naturally occurring in women leads to Dosh Utklesh .Also, the change in lifestyle leads to Mithya Aahar
Vihar which further causes various complications during pregnancy.The only
description of Chardi in Garbhini is that of a lakshana, that is, Sadhyo Gruhit
Garbha Lakshana. If the chardi’s lakshana falls within the normal range, it is
considered Prakrut (harmless).But if it gets excessive and interferes woman’s
daily activities, it is considered as a sickness that requires early intervention to
prevent complications of hyperemesis gravidarum.According
to MEDLINE, PUBMED, and EMBASE lilacs, incidence of emesis gravidarum is 70%,
and that of hyperemesis gravidarum is between 0.8 to 2.3%.
|