| CTRI Number |
CTRI/2023/07/054954 [Registered on: 07/07/2023] Trial Registered Prospectively |
| Last Modified On: |
06/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga Intervention on Menopause |
|
Scientific Title of Study
|
Management of Menopause through Yogic Intervention |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuja Kumari |
| Designation |
P.hD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09897176441 |
| Fax |
|
| Email |
anuja.maa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyadarshini Tewari |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8090029260 |
| Fax |
|
| Email |
pgtpriya55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyadarshini Tewari |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8090029260 |
| Fax |
|
| Email |
pgtpriya55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Banaras Hindu University, Varanasi |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University, Varanasi |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Anuja Kumari |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyadarshini Tewari |
Institute Of Medical Sciences |
Room No-24,Prasuti Tantra Opd,Sir sundar Lal Hospital, IMS, Banaras Hindu University,Varanasi
Varanasi
UTTAR PRADESH |
8090029260
pgtpriya55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Banaras Hindu University, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N951||Menopausal and female climactericstates, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Intervention |
Only advised medicine will be continued which was prescribed by her doctor.
|
| Intervention |
Yoga Intervention |
Yoga Intervention will include - Asana, Pranayama, and Meditation. Yoga Intervention will be given 60 minutes per session, 5 days a week, for 45 days along with the 15-15 days follow-ups. And advised medicine will be continued which was prescribed by her doctor.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Patients will be registered aged between 45 to 55 years with the symptoms of Perimenopause & Menopause.
The Patient is willing to participate in the research work after giving well-informed written consent in a predesigned proforma. |
|
| ExclusionCriteria |
| Details |
Women less than 45 and more than 55 years apart from the age group.
Women who have surgical menopause.
Menopausal women under medical treatment.
Women suffering from any type of chronic disease like Hypertension, Diabetes mellitus, Coronary artery disease, etc.
Women in the perimenopausal age group have heavy bleeding due to any Coagulopathy or pelvic pathology like uterine fibroid, cervical carcinoma, endometrial carcinoma, cervical erosion, cervical polyp, etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from Menopausal symptoms |
45 days Intervention with 3 follow up of 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the impact of Yogic Intervention on Quality of Life.
2.To assess the impact of Yogic Intervention on the Management of stress |
Quality of Life and Stress will be assessed before and after the 45 days trial |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/07/2023 |
| 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="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
|
Menopause is a stage where women face many problems, Menopause is defined as the permanent cessation of menses for 1 year and is physiologically correlated with a decline in estrogen secretion, resulting from the loss of follicular function. It is very common among women between the age of 45 to 55. It affects their daily activities, quality of life, and their daily to day life. Moreover, studies revealed that menopause has also a longer impact on later life, such as osteoporosis, cardiovascular disease, etc. So this research work has been planned to study the impact of the yogic intervention on menopause in Sir Sundar Lal Hospital, Prasuti Tantra OPD. |