| CTRI Number |
CTRI/2025/03/083091 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate comparatively the use of aamra pallava yoga in the management of Garbhini Chardi w.s.r emesis gravidarum |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of aamra pallava yoga 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 Sahil Sanjay Jadhav |
| Designation |
2nd yr post graduate Prasuti Tantra and Stree Roga dept. |
| Affiliation |
Dr.N.A.Magadum ayurvedic medical College hospital and pg research centre Ankli |
| Address |
Dr N A Magdum ayurvedic medical college research centre and hospital Ankli tal-chikodi dist-belgavi karnataka
591213
Dr N A Magdum ayurvedic medical college research centre and hospital Ankli tal-chikodi dist-belgavi karnataka
591213
Belgaum
KARNATAKA
591213
India |
| Phone |
9021434606 |
| Fax |
|
| Email |
sahilsj298@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dr vandana s kulkarni |
| Designation |
professor and HOD of Prasuti Tantra and Stree Roga dept |
| Affiliation |
Dr.N.A.Magadum ayurvedic medical College hospital and pg research centre Ankli |
| Address |
Dr N A Magdum ayurvedic medical college research centre and hospital Ankli tal-chikodi dist-belgavi karnataka
591213
Dr N A Magdum ayurvedic medical college research centre and hospital Ankli tal-chikodi dist-belgavi karnataka
591213
Belgaum
KARNATAKA
591213
India |
| Phone |
9480017899 |
| Fax |
|
| Email |
drvandanaskulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahil Sanjay Jadhav |
| Designation |
2nd yr post graduate Prasuti Tantra and Stree Roga dept. |
| Affiliation |
Dr.N.A.Magadum ayurvedic medical College hospital and pg research centre Ankli |
| Address |
Dr N A Magdum ayurvedic medical college research centre and hospital Ankli tal-chikodi dist-belgavi karnataka
591213
Dr N A Magdum ayurvedic medical college research centre and hospital Ankli tal-chikodi dist-belgavi karnataka
591213
Belgaum
KARNATAKA
591213
India |
| Phone |
9021434606 |
| Fax |
|
| Email |
sahilsj298@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr NA Magadum Ayurvedic Medical college hospital and pg research centre Ankli tal chikodi dist belgaum karnataka
591213
|
|
|
Primary Sponsor
|
| Name |
Dr Sahil Sanjay Jadhav |
| Address |
Dr N A Magadum Ayurvedic Medical college hospital and pg research centre Ankli tal-chikodi dist-belgavi karnataka
591213 |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrSahil Sanjay Jadhav |
Dr.N.A.Magdum hospital Striroga and Prasuti Tantra department OPD no 1 Ankli |
Dr N A Magdum ayurvedic medical college research centre and hospital dept of prasutitantra and striroga OPD no 1 Ankli tal-chikodi dist-belgavi karnataka
591213
Belgaum
KARNATAKA |
9021434606
sahilsj298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. NAMAMC-IEC |
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: Aamra pallava yoga , Reference: Charak samhita sutrasthana 1chapter , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 400(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Doxylamine succinate | Tab Doxylamine succinate 10 mg HS after food for 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients between ahe of 20-35 yrs age
Patient diagnosed as Garbhini chardi in first trimester of pregnancy
Both primi and multiparae |
|
| ExclusionCriteria |
| Details |
Patients with hyper emesis gravidarum.
Patients in whom chardi seen in second and third trimester.
Patients with twin pregnancy, vesicular mole and ectopic pregnancy.
Vomiting caused due to systemic disorders like peptic ulcer, renal calculi, and appendicitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Amra pallava yoga in Garbhini chardi |
45 days or upto first trimester |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study in detail about garbhini chardi.
To study in detail about Emesis Gravidarum.
To do conceptual study in detail about Amra pallava yoga. |
45 days or upto first trimester of pregnancy |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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 - NO
|
|
Brief Summary
|
The present title ’A comparative clinical study to evaluate the efficacy of amrapallava Yoga In The Management Of Garbhini Chardi w.s.r emesis gravidarum ’ A clinical study of 60 registered pregnant women with their inclusion criteria and randomly alloted into 2 groups in each 30. Group A will be administered with amrapallava Yoga 100mg BD with water Group B will be administered with Tab Doxylamine succinate 10 mg 2 Hs. |