| CTRI Number |
CTRI/2025/09/095039 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| 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 Nadi-Shodhan Pranayama on Hormonal and Physiological Changes in Postmenopausal Women |
|
Scientific Title of Study
|
Investigating The Efficacy Of Alternate Nostril Breathing (Nadi-Shodhan Paranayam) In Hormonal And Physiological Changes In Postmenopausal Women |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anushka |
| Designation |
PhD Scholar |
| Affiliation |
Department Of Yoga Sciences Swami Rama Himalayan University |
| Address |
Department Of Yoga Sciences Swami Rama Himalayan University Jollygrant Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248140
India |
| Phone |
8650680559 |
| Fax |
|
| Email |
anushkasaini4789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saloni Malik |
| Designation |
Assistant Professor |
| Affiliation |
Department Of Yoga Sciences Swami Rama Himalayan University |
| Address |
Department Of Yoga Sciences Swami Rama Himalayan University Jollygrant Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248140
India |
| Phone |
8650680559 |
| Fax |
|
| Email |
salonimalik5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anushka |
| Designation |
PhD Scholar |
| Affiliation |
Department Of Yoga Sciences Swami Rama Himalayan University |
| Address |
Department Of Yoga Sciences Swami Rama Himalayan University Jollygrant Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248140
India |
| Phone |
8650680559 |
| Fax |
|
| Email |
anushkasaini4789@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami Rama Himalayan University |
|
|
Primary Sponsor
|
| Name |
Anushka |
| Address |
Swami Rama Himalayan University Jollygrant Dehradun Uttarakhand Pincode-248140 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Anushka |
Swami Rama Himalayan University |
Department of Gynecology Swami Rama Himalayan University Jollygrant Dehradun Uttarakhand Pincode-248140
Dehradun
UTTARANCHAL |
8650680559
anushkasaini4789@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| SWAMI RAMA HIMALAYAN UNIVERSITY |
Approved |
| SWAMI RAMA HIMALAYAN UNIVERSITY |
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 |
| Intervention |
Alternate Nostril Breathing |
Five Days In A Week Upto 12 Weeks |
| Comparator Agent |
Only Follow Up |
Pre And Post Data Will Be Collected By Follicle Stimulating Hormone And By Luteinizing Hormone Test |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Only Post Menopause women will be included
2. Post Menopause women of age group between 45 to 70 Years
3. Who are willing to provide consent
|
|
| ExclusionCriteria |
| Details |
1. Regular practitioner of Yoga
2. Women with physical disabilities
3. Who has had uterus operation
4. Had a history of Menopausal hormone therapy
5. Undergone any surgery in the past 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.FSH (Follicle Stimulating Hormone)
2.LH (Luteinizing Hormone)
|
1.Assessment - Baseline
2. post intervention after 12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Vasomotor Symptoms (Hot Flushes, Night Sweats, Palpitations),
2.Blood Pressure
3.Body Mass Index
4.Menopausal Rating Scale
|
1.Assessment - Baseline
2.Post intervention after 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
05/10/2025 |
| 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="4"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Scientific Title:
Investigating the Efficacy of Alternate Nostril Breathing (Nadi-Shodhan Pranayama) in Hormonal and Physiological Changes in Postmenopausal Women: A 12-Week Randomized Controlled Trial
Public Title:
Efficacy of Alternate Nostril Breathing (Nadi-Shodhan Pranayama) on Hormonal and Physiological Changes in Postmenopausal Women
Health Condition / Problem Studied:
Menopausal and female climacteric states (ICD-10: N95.1)
Study Design:
Prospective, randomized controlled trial with block randomization and allocation concealment (SNOSE). Statistician blinded.
Study Population:
Postmenopausal women aged 45–70 years.
-
Inclusion: Women 45–70 years, postmenopausal, consenting.
-
Exclusion: Regular yoga practitioners, history of hormone therapy, uterine surgery, recent surgery (within 3 months), or physical disability.
Sample Size:
128 participants (64 intervention, 64 control).
Setting:
Himalayan Institute of Hospital Trust, Swami Rama Himalayan University, Uttarakhand, India.
Intervention:
-
Experimental group: 12-week structured yoga program (35 minutes/day, 5 days/week), including Nadi-Shodhan pranayama, selected yoga postures, diaphragmatic breathing, bhramari pranayama, relaxation, and guided meditation.
-
Control group: Usual care.
Primary Outcomes:
Secondary Outcomes:
-
Vasomotor symptoms (hot flushes, night sweats, palpitations)
-
Blood pressure
-
Body Mass Index (BMI)
-
Menopausal Rating Scale / MENQOL questionnaire
Duration:
12 weeks of intervention with assessments at baseline and 12 weeks.
Analysis Plan:
Data entry in Excel; descriptive statistics for categorical and continuous variables.
Comparisons using chi-square test, Student’s t-test, paired t-test, and repeated measures ANOVA.
Multivariate analysis with logistic regression; Kaplan-Meier and log-rank test for outcome comparisons. |