| CTRI Number |
CTRI/2025/05/087946 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yoga for Premenstrual syndrome |
|
Scientific Title of Study
|
Integral yoga protocol for managing Premenstrual syndrome: 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 Rudra Bhandari |
| Designation |
Associate Professor |
| Affiliation |
Department of yogic science |
| Address |
University of Patanjali Patanjali Yogpeeth-1, Haridwar-249405, UK, India
Department of yoga, room no. 1, ground floor, University of Patanjali, Haridwar-249405, Uttarakhand University of Patanjali Hardwar UTTARANCHAL 249405 India |
| Phone |
9634510540 |
| Fax |
|
| Email |
yogidrrudra@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rudra Bhandari |
| Designation |
Associate Professor |
| Affiliation |
Department of yogic science |
| Address |
University of Patanjali Patanjali Yogpeeth-1, Haridwar-249405, UK, India
Department of yoga, room no. 1, ground floor, University of Patanjali, Haridwar-249405, Uttarakhand University of Patanjali Hardwar UTTARANCHAL 249405 India |
| Phone |
9634510540 |
| Fax |
|
| Email |
yogidrrudra@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Komal |
| Designation |
Research Scholar |
| Affiliation |
University of patanjali |
| Address |
University of Patanjali Patanjali Yogpeeth-1, Haridwar-249405, UK, India
Department of yoga science, ground floor, university of Patanjali, haridwar-249405 University of Patanjali Patanjali Yogpeeth-1, Haridwar-249405, UK, India
Department of yoga science, ground floor, university of Patanjali, haridwar-249405 Hardwar UTTARANCHAL 249405 India |
| Phone |
08958053565 |
| Fax |
|
| Email |
komalyoga25@gmail.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
University of Patanjali |
| Address |
Delhi-Haridwar Highway, Patanjali Yogpeeth-1, Haridwar-249405, Uttarakhand |
| Type of Sponsor |
Other [Private University] |
|
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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 |
| Komal |
Patanjali Ayurved Hospital |
Patanjali Yogpeeth phase-1, OPD-6, Department of gynecology, Haridwar, Uttaranchal, pin code-249405 Hardwar UTTARANCHAL |
08958053565
komalyoga25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of University of Patanjali |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N943||Premenstrual tension syndrome. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Peedantak vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: NIL | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Peedantak vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: In addition to the above medication, participants in the intervention arm will receive an Integrated yoga module comprising asana, mudra, bandha, meditation, and naad yoga, administered for 60minutes/day, 5 days/week, over 9 weeks. |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
The study will include females between the ages of 18 and 40 who experience premenstrual syndrome (PMS). Eligible participants must have a regular menstrual cycle, ensuring the consistency needed to accurately assess the impact of PMS. Additionally, participants must be willing to provide informed consent and actively participate in the study.
|
|
| ExclusionCriteria |
| Details |
The study will exclude females of reproductive age who have chronic infectious diseases, mental health issues, or any addictive behaviors such as smoking, alcoholism, or drug addiction. Additionally, individuals who have undergone recent surgery or are currently pregnant will not be eligible for participation. Those who express a disinterest in yoga or are already engaged in regular yoga practice, along with those who consistently participate in other forms of exercise, will also be excluded from the study. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes:
The severity of symptoms of PMS including depression, anxiety and stress measured by DASS questionnaire, (2) fatigue measured by fatigue severity scale, (3) mood swings measured by the brief mood introspection scale, (4) quality of life or well-being measured by the premenstrual syndrome quality of life scale, including alterations in sleep patterns, cramps/pain (including headaches and abdominal, back, and lower back pain). |
At baseline (T0) and at 3 months (T1) |
|
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Secondary Outcome
|
|
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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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="4" 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
|
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Brief Summary
|
In modern society, premenstrual syndrome (PMS) has emerged as a prevalent concern among women of reproductive age, often manifesting through emotional instability, fatigue, irritability, and physical discomfort. These symptoms significantly disrupt daily functioning, personal relationships, and professional responsibilities. While healthcare systems aim to promote holistic well-being for women, PMS continues to pose a barrier to optimal mental and physical health. The cumulative impact of PMS on emotional balance, work productivity, and social engagement highlights the urgent need for effective, non-pharmacological interventions. Yoga, widely acknowledged for its integrative benefits on the mind and body, has gained global attention as a therapeutic tool. In India, where yoga is officially supported by the Ministry of AYUSH, it is increasingly incorporated into health interventions for women’s wellness (Khemka et al., 2011). This study investigates the effectiveness of an Integral Yoga Protocol in managing PMS symptoms among women aged 18 to 40 through a randomized controlled trial. By integrating asanas, pranayama, and meditation, the protocol addresses the physical discomfort and emotional fluctuations associated with PMS, aiming to enhance hormonal balance, psychological resilience, and overall quality of life. This research highlights the potential of integral yoga as a holistic, accessible solution for improving women’s reproductive health and well-being. |