| CTRI Number |
CTRI/2025/03/082266 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Kola- Amalaki phala churna in Vomiting in first three months Of Pregnancy |
|
Scientific Title of Study
|
An Open Randomised Controlled Clinical study of Kola-
Amalakimajja churna with Anupan Madhu in Garbhini Chardi w.s.r.Emesis Gravidarum in First trimester of Pregnancy |
| 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 Prajakta Ashok Nikrad |
| Designation |
PG student of Prasutitantra avum strirog Department |
| Affiliation |
Yashwant Ayurvedic College and research centre kodoli |
| Address |
OPD no 8 department Of stree rog Evum Prasutitantra
Yashwant Ayurvedic College and research centre Kodoli kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9130160592 |
| Fax |
|
| Email |
prajaktanikrad1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Mule |
| Designation |
Guide and Associate Professor |
| Affiliation |
Yashwant Ayurvedic College and research centre kodoli kolhapur |
| Address |
OPD no 8 department of Streeroga Evum Prasutitantra Yashwant Ayurvedic College and research centre kodoli kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277612 |
| Fax |
|
| Email |
kvt126@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajakta Ashok Nikrad |
| Designation |
PG student of Prasutitantra avum strirog Department |
| Affiliation |
Yashwant Ayurvedic College and research centre kodoli kolhapur |
| Address |
OPD no 8 Stree rog Prasuti tantra OPD Yashwant Charitable
Hospital Kodoli tal panhala dist kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9130160592 |
| Fax |
|
| Email |
prajaktanikrad@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no 8 Stree rog Prasuti tantra OPD Yashwant Charitable
Hospital Kodoli tal panhala dist kolhapur OPD no 8 Stree rog Prasuti
tantra OPD Yashwant Charitable Hospital Kodoli tal panhala dist
kolhapur
Kolhapur
MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
Dr Prajakta Ashok Nikrad |
| Address |
OPD no 8 Stree rog Prasuti tantra Yashwant Charitable
Hospital Kodoli tal panhala dist kolhapur
416114
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 Prajakta Ashok Nikrad |
Yashwant charitable Hospital |
OPD no 8, Stree rog and Prasutitantra department, Yashwant Charitable Hospital Kodoli kolhapur
Kolhapur
MAHARASHTRA |
9130160592
prajaktanikrad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O20-O29||Other maternal disorders predominantly related to pregnancy. Ayurveda Condition: GARBINISARPADASHTAH, (2) ICD-10 Condition:O00-O9A||Pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kola -amalakimajja churna, Reference: Sushrut samhita Uttar Tantra 47 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu ), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Doxylamine succinate 10mg and pyridoxine hydrochloride 10mg | Twice a day before food with water for seven days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Patient with intra uterine pregnancy having signs and symptoms of garbhini chardi .
2) Patient diagnosed as garbhini chardi i.e. morning sickness in first trimester.
3) Patient irrespective of parity, caste, income group, occupation. |
|
| ExclusionCriteria |
| Details |
1) Patient with Hyperemesis Gravidarum.
2) Patient in whom chardi seen in second and third trimester.
3) Vomiting caused due to other systemic disorders like acidpeptic disorders, etc.
4) Gestational trophoblastic disease and multiple pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of kola-Amalakimajja churna
in Garbhini Chardi w.s.r. to Emesis Gravidarum |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce the sign and symptoms of garbhini chardi.
To assess improvement by signs, symptoms and gradation of Assessment criteria.
To Achieve the control on Frequency of Vomiting of the patient.
To study etiopathology of Garbhini Chardi in detail according to Ayurveda & emesis gravidarum in detail according to modern text.
To achieve the outcome of study in 15 days. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prajaktanikrad@gmail.com].
- For how long will this data be available start date provided 18-03-2025 and end date provided 18-03-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This is randomised open controlled clinical study to evaluate the efficacy of kola- amalakimajja churna 3gm twice daily before food orally for 7 days in garbhini chardi observation will be made upon symptoms of garbhini chardi study will be carried out in OPD of Stree rog Prasuti tantra department of Yashwant Charitable Hospital Kodoli The Primary outcome to evaluate the efficacy of kola-amalakimajja churna 3gm twice daily before food orally in 7 days. The secondary outcome will be assess improvement by signs, symptoms and gradation of assessment criteria. |