| CTRI Number |
CTRI/2022/09/045546 [Registered on: 15/09/2022] Trial Registered Prospectively |
| Last Modified On: |
26/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Yogasana during Pregnancy |
|
Scientific Title of Study
|
A Clinical Trial to Evaluate effects of Yogasanas during Pregnancy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravesh Tomar |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
Prasuti Tantra Evum Stree Roga Department Rishikul Campus Haridwar 249401 Uttarakhand Ayurveda University Harrawala Dehradun
OPD No 9 Prasuti Tantra Evum Stree Roga Department Rishikul Campus Haridwar 249401 Uttarakhand Ayurveda University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
98708999895 |
| Fax |
|
| Email |
praveshtomarlal@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravesh Tomar |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
Prasuti Tantra Evum Stree Roga Department Rishikul Campus Haridwar 249401 Uttarakhand Ayurveda University Harrawala Dehradun
OPD No 9 Prasuti Tantra Evum Stree Roga Department Rishikul Campus Haridwar 249401 Uttarakhand Ayurveda University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
98708999895 |
| Fax |
|
| Email |
praveshtomarlal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravesh Tomar |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
Prasuti Tantra Evum Stree Roga Department Rishikul Campus Haridwar 249401 Uttarakhand Ayurveda University Harrawala Dehradun
OPD No 9 Prasuti Tantra Evum Stree Roga Department Rishikul Campus Haridwar 249401 Uttarakhand Ayurveda University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
98708999895 |
| Fax |
|
| Email |
praveshtomarlal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Prasuti Tantra Evum Stree Roga Department Rishikul Campus Haridwar 249401 Uttarkhand Ayurveda University |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus Haridwar Uttarakhand Ayurveda University |
| Address |
rasuti Tantra Evum Stree Roga Department Rishikul Campus Haridwar 249401 Uttarkhand Ayurveda University |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pravesh Tomar |
Rishikul Campus haridwar |
Department of Prasuti Tantra Evum Stree Roga Rishikul Campus Uttarakhand Ayurveda University Haridwar
249401
Hardwar
UTTARANCHAL |
9870899895
praveshtomarlal@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O30-O48||Maternal care related to the fetus and amniotic cavity and possible delivery problems. Ayurveda Condition: garbhini vihara, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: yogasana five minute in each asanas and three minute rest total duration 45 minute, Ritucarya: nil, Acara Rasayana:nil, Other:five minute in each asanas and three minute rest total duration of yogasana will be of 45 minutes, Pathya/Apathya:yes, Pathya:light diet will be advised before practising yoga and pranayam, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant female age between 20 yrs to 35 yrs
2.Investigations blood Serum and Urine test within normal limits |
|
| ExclusionCriteria |
| Details |
1. Pregnant female having history of previous cesarean section
2.Having any Placental abnormality
3.Pregnancy with Fibroid
4.Twin pregnancy
5.Systemic illness like Anaemia, HTN, DM, Jaundice, any Respiratory disorder |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evualute effects of yogasanas during pregnancy |
each trimester of 9 months pregnancy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A clinical trial to evualute effects of yogasanas during pregnancy |
each trimester of 9 months pregnancy (12 weeks) |
| Evaluate the effects of yogasanas in pregnancy |
9 months of pregnancy |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3 |
|
Date of First Enrollment (India)
|
20/09/2022 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Practice of Yoga unite physical and psychological health and creates balance between physical, mental, emotional and spiritual well being.Yoga realxes the mind and prepare the women Physiologically and psychologically for Labour.
Pregnant females of age 20yrs to 30yrs are selected to perform Yoga in Each trimester.
One session in every trimester is 45 minutes.
Asanas In standing position - Pranamasana, Tadasana, Hastottanasana
Asanas In sitting position- Dandasana, Ardhapadmasana, Gomukhasana,Malasana
Asanas In lying down position - Balasana, Ardhahalasana, Shavasana
|