| CTRI Number |
CTRI/2025/02/080331 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of yoga in third trimester of pregnancy |
|
Scientific Title of Study
|
Effect of third trimester yoga protocol in primigravida on labour process : A randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aastha |
| Designation |
Post Graduate Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Stri Rog Evam Prsuti Tantra 4th Floor Academic block All India Institute of Ayurveda Mathura Road Gautam puri Sarita Vihar Delhi
South
DELHI
110076
India |
| Phone |
8700872032 |
| Fax |
|
| Email |
aastha0096@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sujata Kadam |
| Designation |
Head of Department |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Stri Rog Evam Prsuti Tantra Room no 401 4th Floor Academic block All India Institute of Ayurveda Mathura Road Gautam puri Sarita Vihar Delhi
South
DELHI
110076
India |
| Phone |
9890305370 |
| Fax |
|
| Email |
sujatadkadam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Sujata Kadam |
| Designation |
Head of Department |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Stri Rog Evam Prsuti Tantra Room no 401 4th Floor Academic block All India Institute of Ayurveda Mathura Road Gautam puri Sarita Vihar Delhi
South
DELHI
110076
India |
| Phone |
9890305370 |
| Fax |
|
| Email |
sujatadkadam@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Mathura Road Gautampuri Sarita Vihar New Delhi 110076 |
| 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 Sujata Kadam |
all india institute of ayurveda |
Room no. 002,ground floor,Director office, Academic block,All India Institute of Ayurveda, Sarita Vihar,South Delhi
South
DELHI |
9890305370
sujatadkadam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Division of translation research and biostatics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O80||Encounter for full-term uncomplicated delivery. Ayurveda Condition: PRAJAYANI-PRAJANANAKALAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: dhatri loha and mukta shukti pisthi , Reference: bhasjiya ratnavali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 9 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:yoga protocol to be followed
frequency OD
duration 45 minutes for 90 days in third trimester
Yoga asanas tadasana trikonasana ardhparshkon asana dandasana sukhasana konasana parivratjanushri asana marjariasana suptbadhkonasana shavasana
Reference SOP in Preconceptional and prenatal care through Ayurveda department of prasuti tantra and striroga AIIA
Meenakshi Pathak et al effect of yogic practices on pregnancy and its outcome anvikshiki the Indian journal of research vol 7 no 1 jan 2013
, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
3rd trimester Primigravida
Not having any known obstetrical or medical issues
Singleton pregnancy
An ultrasound revealed no foetal abnormalities or intrauterine growth restriction |
|
| ExclusionCriteria |
| Details |
Pregnancy induced hypertension, hypo/hyperthyroiddism
IUGR or other foetal abnormalities
patient not willing for trial |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bishops score, partograph, pain score apgar weight of baby |
38-40 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Labour outcome (baby weight, APGAR score
Postpartum period (depression,anxiety) |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
Research question - effect of third trimester yoga protocol in primigravida on labour process : A randomised clinical trial. Study Design - Randomised double arm clinical study Study type - Comparative study Masking - Open Label Sample size - 40 Setting - OPD IPD AIIA Group - 2 Duration - 3 months follow up - 1 month Group A Intervention - Yoga Duration - Begining of 3rd trimister till labour process begins Time - 45 minutes Group B Intervention - control group taking regular ANC ayurvedic regimen as followed in AIIA Medicine - Dhatri loha 500mg BD with water, Mukta shukti pisthi 500mg BD with water from 28 weeks till delivery Stastical method - SPSS version 26. level of significance : p<0.05 Primary outcome - Mode of delivery, duration of labour Secondary outcome - Labour outcome, Postpartum period ( depression, anxiety) Investigations done - CBC with ESR, TFT, GTT USG Assesment criteria - Fetal weight by USG, induction required or nott, onset of labour, duration and frrquency of utreine contrations, labour process according to partogram, boshop’s score Yoga Protocol - SOP in preconceptional and prenatal care through ayurveda department of SRPT AIIA |