| CTRI Number |
CTRI/2024/07/070500 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The effect of baladi yoga and garbhasanskara on mother and fetus. |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of baladi yoga and garbhasanskara on mother and fetus. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrLipakshi Agrawal |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Govt.Ayurveda College |
| Address |
PG Department of Prasuti Tantra Evam Stri Roga
Madan Mohan Malviya Govt.Ayurveda College,Ambamata Udaipur Rajasthan 313001 India
Udaipur
RAJASTHAN
313001
India |
| Phone |
8003697919 |
| Fax |
|
| Email |
lipakshi0798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diksha Khathuria |
| Designation |
Lecturer and guide |
| Affiliation |
Madan Mohan Malviya Govt.Ayurveda College, |
| Address |
PG Department of Prasuti Tantra Evam Stri Roga
Madan Mohan Malviya Govt.Ayurveda College,Ambamata Udaipur Rajasthan 313001 India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413727680 |
| Fax |
|
| Email |
diksha.khathuria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diksha Khathuria |
| Designation |
Lecturer and guide |
| Affiliation |
Madan Mohan Malviya Govt.Ayurveda College, |
| Address |
PG Department of Prasuti Tantra Evam Stri Roga
Madan Mohan Malviya Govt.Ayurveda College,Ambamata Udaipur Rajasthan 313001 India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413727680 |
| Fax |
|
| Email |
diksha.khathuria@gmail.com |
|
|
Source of Monetary or Material Support
|
| madan mohan malviya govt. ayurved college , ambamata udaipur, rajasthan , india
pincode - 313001 |
|
|
Primary Sponsor
|
| Name |
madan mohan malviya govt ayurved college udaipur |
| Address |
madan mohan malviya govt. ayurveda college , udaipur rajasthan ,313001, india
pincode - 313001 |
| Type of Sponsor |
Government medical college |
|
|
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 Lipakshi Agrawal |
mmm govt. ayurved college, udaipur & associated hospitals. |
opd no.- 5 , mmm govt. ayurved college, udaipur
Udaipur
RAJASTHAN |
8003697919
lipakshi0798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee mmm govt. ayurved college udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: BALADI YOGA, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -MILK), Additional Information: FOLLOW UP AFTER EVERY 15 DAYS FOR CONSECUTIVE 3 MONTHS |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) Patient willing for trial.
2) Pregnant women with age 20-40 years.
3) Women up to 28 weeks of pregnancy.
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing for trial.
2.Subject with a history of any other complications during pregnancy like placenta previa, abruptio placenta, pregnancy induced hypertension.
3.Patients with hemoglobin less than 7gm%.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess wellbeing of maternal and fetal health. |
baseline, 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in minor ailments of mother. |
baseline , 12 weeks. |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="0"
Months="3"
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
|
This study is to evaluate the efficacy of baladi yoga and garbhasanskara on mother and fetus. There will be single group of 30 patients in which patients are treated with baladi yoga (5gm) with milk bid orally for 90 days . Case will be followed after the course of every 15 days for consecutive 3 months. The purpose of this trial is to evaluate the wellbeing of mother and fetus as well as to treat the minor ailments of mother. |