| CTRI Number |
CTRI/2025/11/096902 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the efficacy of Bhunimbadi Churna in nausea and vomiting during pregnancy |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABEL TRIAL STUDY TO EVALUATE THE EFFICACY OF BHUNIMBADI CHURNA IN THE MANAGEMENT OF GARBHINI CHARDI W.S.R. TO EMESIS GRAVIDARUM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anumeha Sachan |
| Designation |
PG Student |
| Affiliation |
MGGAU, Gorakhpur |
| Address |
Department Of PG Studies in PTSR, Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bewar Road farukkhabad
Farrukhabad
UTTAR PRADESH
209620
India |
| Phone |
9810996282 |
| Fax |
|
| Email |
Anumehasachan14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Salim musa mulla |
| Designation |
Professor and HOD |
| Affiliation |
MGGAU, Gorakhpur |
| Address |
Department Of PG Studies in PTSR,Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bewar Road farukkhabad
Farrukhabad
UTTAR PRADESH
209620
India |
| Phone |
9810996282 |
| Fax |
|
| Email |
drsmmulla@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anumeha Sachan |
| Designation |
PG Student |
| Affiliation |
MGGAU, Gorakhpur |
| Address |
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bewar Road farukkhabad
Kanpur Nagar
UTTAR PRADESH
209620
India |
| Phone |
9810996282 |
| Fax |
|
| Email |
Anumehasachan14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bewar Road farukkhabad 209620, India |
|
|
Primary Sponsor
|
| Name |
Dr Anumeha Sachan |
| Address |
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bewar Road farukkhabad 209620 India |
| 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 Anumeha Sachan |
Shree babu singh jai singh ayurvedic medical college and hospital |
Room no 6 Devision 2 Departmentof strirog and prasuti tantra farrukhabad
Farrukhabad
UTTAR PRADESH |
9810996282
Anumehasachan14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhunimbadi Churna , Reference: Harita Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Caw milk), Additional Information: 3-5 grams after food with cow milk |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida or multigravida irresepective of og age caste and religion having gestational age of 8th to 14th weeks with complaint of vomiting. |
|
| ExclusionCriteria |
| Details |
Subjects having hemorrhagic disorders, having precious pregnancy, or vomiting due to other causes ie appendicitis, pregnancy with jaundice, cholecystitis or intestinal obstruction, Subjects suffering with TB, DM etc or HIV/ HBsAg positive |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To relieve symptoms and Effects of vomiting in pregnancy |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/11/2025 |
| 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="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
I will give Bhunimbadi churna along with gau dugdha to inclusive patients for 2 weeks, then observe symptomatic changes and will compare the results in given patient before and afterwards. |