| CTRI Number |
CTRI/2025/10/095749 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
BHRAMARI AND NAADI SHUDDHI PRANAYAMA INTERVENTION ON MENOPAUSAL SYMPTOMS IN POST MENOPAUSAL WOMEN |
|
Scientific Title of Study
|
ASSESSING THE EFFICACY OF BHRAMARI AND NAADI SHUDDHI PRANAYAMA ON MENOPAUSAL SYMPTOMS IN POST MENOPAUSAL WOMEN: A SINGLE-ARM PROSPECTIVE CLINICAL 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 S SATHISH KUMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
SECOND YEAR, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8778769094 |
| Fax |
|
| Email |
sathishkumar17121998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR V MAHALAKSHMI MD SIDDHA |
| Designation |
PROFESSOR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
HEAD OF THE DEPARTMENT, DEPARTMENT OF SIDDHAR YOGA
MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,
PALAYAMKOTTA
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8248818479 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR V MAHALAKSHMI MD SIDDHA |
| Designation |
PROFESSOR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
HEAD OF THE DEPARTMENT, DEPARTMENT OF SIDDHAR YOGA
MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,
PALAYAMKOTTA
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8248818479 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR S SATHISH KUMAR |
| Address |
SECOND YEAR, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM,
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Type of Sponsor |
Other [NIL] |
|
|
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 S SATHISH KUMAR |
Government siddha medical college and Hospital, palaiyamkottai |
Second year, department of Siddhar yoga maruthuvam, government of siddha medical college and Hospital, palaiyamkottai, Tirunelveli, Tamil Nadu
Tirunelveli
TAMIL NADU |
8778769094
sathishkumar17121998@gmail.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 |
| Healthy Human Volunteers |
POST MENOPAUSAL WOMENS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
SIDDHAR THERAPEUTIC YOGIC PROCEDURE |
PRANAYAMAM:
Total timing - 10 - 30 minutes
1. NAADI SHUDDHI PRANAYAMA - 5 - 15 Minutes
2. BHRAMARI PRANAYAMA - 5 - 15 Minutes |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Women who have experienced natural menopause (12 consecutive months of
amenorrhea)
If any 3 of the following symptoms of menopause are present, the participants will be
included for the study.
Joint and Muscular Discomfort.
Hot Flashes
Sleep Disturbances
Depressive mood .
Irritability.
Anxiety.
Mental and Physical Exhaustion
Vaginal Dryness |
|
| ExclusionCriteria |
| Details |
Severe Medical conditions.
Psychiatric disease
Hormone Replacement Therapy (HRT).
H/o Cardiac disorders.
Women with prior experience practicing yoga or pranayama
Any other serious systemic illness.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The expected outcome is Pranayama offers a natural, low risk approach to managing
menopausal Symptoms |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Specifically Bhramari and Naadi Shuddhi pranayama in management of Post menopausal symptoms |
48 days |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 2 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Potential Benefits for Research both Bhramari and Naadi Shuddhi Pranayama may
offer benefits for various health conditions, including: Reducing anxiety and promoting
relaxation. Improving lung function and overall respiratory well-being. Enhancing cognitive
function, balance, and coordination
Siddhar Yogic Intervention Naadi Shuddhi pranayama Bhramari pranayama |