| CTRI Number |
CTRI/2024/01/061542 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Benefit of yoga intervention on menopausal symptoms in women at different phases of the menopause. |
|
Scientific Title of Study
|
Effect of yogic intervention on menopausal symptoms in women under different menopausal stages: An Interventional Study |
| 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. Ankita Singh Bisht |
| Designation |
Student |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
F-1 Block, LGF, Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Sector- 125, Noida- 201303, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
8920657720 |
| Fax |
|
| Email |
ankita.16bisht@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pragya |
| Designation |
Assistant Professor |
| Affiliation |
Amity Imstitute of Health Allied Sciences |
| Address |
Room No.- 107A, First Floor, Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Sector-125, Noida- 201303, Uttar Pradesh, India
First Floor
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragya |
| Designation |
Assistant Professor |
| Affiliation |
Amity Imstitute of Health Allied Sciences |
| Address |
Room No.- 107A, First Floor, Depatment of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Sector- 125, Noida- 201303, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity Institute of Health Allied Sciences, Amity University |
|
|
Primary Sponsor
|
| Name |
Dr Ankita Singh Bisht |
| Address |
F-1 Block, LGF, Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Sector- 125, Noida- 201303, Uttar Pradesh, India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Ankita Singh |
Orthi Neuro Chiropractic Physiotherapy Clinic |
C-163, C Block, Sector- 26, Noida
Gautam Buddha Nagar
UTTAR PRADESH |
8920657720
ankita.16bisht@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Amity University, Noida |
Approved |
| Ortho Neuro Chiropractic Physiotherapy Clinic |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Menopausal Women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Yogic Intervention |
Yogic intervention for 6 weeks. At first 5 days in a row of 1.5 hours per day of intensive yoga steps training. Following 5 days women will do solo yoga at home for 35-40 minutes and for the next 6 weeks, they practice group yoga twice a week under the investigators supervision. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Women who will give their consent
40-65 years of age
Pre, peri, and post-menopausal women based on WHO criteria
Women with 2- 8 scoring in the physical domain of MENQOL
Women who entered menopause naturally |
|
| ExclusionCriteria |
| Details |
Anyone who denies consent
History of cardiovascular disease (such as asthma, COPD)
History of gynecological problems (such as uterine fibroids, dysfunctional uterine bleeding, prolapsed uterus)
History of antidepressant use
History of hormonal therapy
ovariectomy
Pregnant and breastfeeding women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Menopause Specific Quality of Life (MENQOL). To assess musculoskeletal pain and quality of life in menopausal women after 2,4 and 6 weeks of intervention. |
Assessment to be done after 2, 4, and 6 weeks of Intervention. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
20/01/2024 |
| 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="1"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 purpose of the study is to evaluate the effect of yogic intervention on menopausal symptoms in women under different menopausal stages.
Methodology An Interventional study, designed using purposive sampling. The study will recruit 72 menopausal women of age group 40- 65 years. They will further be divided into three stages of menopause based on their symptoms. Then they will be given yoga intervention to Check the effect of yoga on menopausal symptoms. Yoga Intervention will include asanas, pranayam, and meditation. Menopause specific quality-of-life questionnaire will be used to assess the symptoms which will be assessed every 2 weeks. The data will be analyzed at the end of the study. |