| CTRI Number |
CTRI/2026/06/111638 [Registered on: 01/06/2026] Trial Registered Prospectively |
| Last Modified On: |
29/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Yoga versus Standard Treatment alone for Sleep Disturbances among Perimenopausal Women |
|
Scientific Title of Study
|
Efficacy of Yoga along with Standard Treatment versus Standard Treatment alone for Sleep Disturbances among Perimenopausal Women - A Randomized Controlled Trial |
| 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 Neel Kamal |
| Designation |
PG Scholar |
| Affiliation |
Government Institute of Medical Sciences(GIMS) |
| Address |
Department of Obs and Gynaecology, Room 3 ground floor,GIMS Hospital
Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9454276926 |
| Fax |
|
| Email |
drneelkamal167@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Verma |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical Sciences(GIMS) |
| Address |
Department of Obs and Gynaecology, Room 3 ground floor,GIMS Hospital
Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9634795413 |
| Fax |
|
| Email |
sdruchi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritu Sharma |
| Designation |
Professor and Head |
| Affiliation |
Government Institute of Medical Sciences(GIMS) |
| Address |
Department of Obs and Gynaecology, room 3 ground floor,GIMS Hospital
Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9717001590 |
| Fax |
|
| Email |
drritu661@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of Institute of Medical Sciences (GIMS)
Kasna, Greater Noida, Gautam Budhha Nagar, Uttar Pradesh, Pin-201310 |
|
|
Primary Sponsor
|
| Name |
Government of Institute of Medical Sciences (GIMS) |
| Address |
Kasna, Greater Noida Gautam Buddha Nagar Pin-201310 |
| 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 Neel Kamal |
Government of Institute of Medical Sciences (GIMS) |
Department of Obs and Gynecology, Gims Hospital, Kasna Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9454276926
drneelkamal167@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GIMS Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F063||Mood disorder due to known physiological condition, (2) ICD-10 Condition: F079||Unspecified personality and behavioral disorder due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Treatment SSRI (Tab Escitalopram- 10mg/day-20mg/day) |
Standard Treatment SSRI (Tab Escitalopram- 10mg/day-20mg/day) |
| Intervention |
Yoga Plus Standard Treatment |
Yoga + Standard Treatment SSRI (Tab Escitalopram- 10mg/day-20mg/day) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Perimenopausal women between ages 40 to 55years with recent onset of sleep disturbances.
Having sleep disturbances 3 nights/wk at least for 3 months(12)
Women not having any psychiatric illness
Accessibility to smartphone
Willing to participate
Practising sleep hygiene
|
|
| ExclusionCriteria |
| Details |
Having psychiatric disorders,anxiety or heart disease.
Co-existing Orthopaedic problems and chronic illnesses.
Current participation in structured exercise or yoga programs
Undergoing hormone replacement therapy
H/O cancer
Premature ovarian failure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of Yoga along with Standard Treatment versus Standard Treatment alone for Sleep Disturbances among Perimenopausal Women. |
TFrom Baseline to end of intervention at week 4 week 8 week 12. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the effect of Yoga on other somatic symptoms among Perimenopausal Women
2. To assess the effect of yoga on overall QOL among Perimenopausal Women.
|
TFrom Baseline to end of intervention at week 4 week 8 week 12. |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
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 4 |
|
Date of First Enrollment (India)
|
15/06/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 study will be started after obtaining ethical clearance from Institutional Ethics Committee. Informed & written consent will be taken prior the recruitment. All study participants in the study will undergo detailed history (present, past, gynaecological, medical, and family history) followed by general physical examination. The participants will be selected on the basis of inclusion criteria and will be randomly assigned to the yoga or control groups in a 1:1 ratio; the randomization will be done by using a computer program. 4 scales will be used for assessment & follow up i.e. Pittsburgh Sleep Quality Index (PSQI) (19), The Menopause-specific Quality of Life (MENQOL) (20), Menopause rating scale (MRS) (21) and Insomnia Severity Index (ISI). |