CTRI/2024/07/071101 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On:
18/07/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A clinical study to compare the efficacy of jeera powder and yoga therapy in primary dysmenorrhea.
Scientific Title of Study
An open label double arm randomised controlled clinical study to compare the efficacy of jeeraka churna and integrated yoga therapy in udavartini yonivyapad, primary dysmenorrhea.
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 Shravya M Jain
Designation
PG Scholar
Affiliation
SDM Institute of Ayurveda and Hospital, Anchepalya, Bangalore, Karnataka, 560074, India
Address
Department of Prasooti tantra and stree roga, OPD No. 4,5,6,24,29.SDM Institute of Ayurveda and Hospital, SH17, Anchepalya, Bangalore, Karnataka, 560074, India
Bangalore KARNATAKA 560074 India
Phone
9482030197
Fax
Email
shravyamjain@gmail.com
Details of Contact Person Scientific Query
Name
Dr Shweta C Dindur
Designation
Associate professor
Affiliation
SDM Institute of Ayurveda and Hospital, Anchepalya, Bangalore, Karnataka, 560074, India
Address
Department of Prasooti tantra and stree roga, OPD No.6.
SDM Institute of Ayurveda and Hospital, SH17, Anchepalya, Bangalore, Karnataka, 560074, India
Bangalore KARNATAKA 560074 India
Phone
9535201172
Fax
Email
drshweta@sdmayurbangalore.in
Details of Contact Person Public Query
Name
Dr Shravya M Jain
Designation
PG Scholar
Affiliation
SDM Institute of Ayurveda and Hospital, Anchepalya, Bangalore, Karnataka, 560074, India
Address
Department of Prasooti tantra and stree roga, OPD No. 4,5,6,24,29.SDM Institute of Ayurveda and Hospital, SH17, Anchepalya, Bangalore, Karnataka, 560074, India
Bangalore KARNATAKA 560074 India
Phone
9482030197
Fax
Email
shravyamjain@gmail.com
Source of Monetary or Material Support
Department of Prasooti tantra and stree roga, OPD No. 4,5,6,24,29.SDM Institute of Ayurveda and Hospital, SH17, Anchepalya, Bangalore, Karnataka, 560074, India
Primary Sponsor
Name
Dr Shravya M Jain
Address
Department of Prasooti tantra and stree roga, OPD No. 4,5,6,24,29.SDM Institute of Ayurveda and Hospital, SH17, Anchepalya, Bangalore, Karnataka, 560074, India
Type of Sponsor
Other [self]
Details of Secondary Sponsor
Name
Address
Nil
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Shravya M Jain
SDM Institute of Ayurveda and Hospital, Bangalore
Department of Prasooti tantra and stree roga, OPD No. 4,5,6,24,29.SDM Institute of Ayurveda and Hospital, SH17, Anchepalya, Bangalore, Karnataka, 560074, India Bangalore KARNATAKA
9482030197
shravyamjain@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital
1.Patients fulfilling the diagnostic criteria, having score 5-7 on VAS scale with Painful menstruation for atleast 3 Consecutive cycles.
2.Age group 18-25 years
3.Patient with regular menses.
ExclusionCriteria
Details
1. Patient with Congenital uterine anomalies leading to Dysmenorrhea
2. Patients with any systemic illness like DM ,HTN.
3. Patient with IUCD
4. Patient with pelvic pathology like pelvic inflammatory diseases,Fibroid uterus,Adenomyosis
5. Patients taking oral contraceptive pills
Improvement in quality of life according to WHOQOL-BREF
baseline,30day,60day,90day
Target Sample Size
Total Sample Size="60" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="60"
Phase of Trial
Phase 2/ Phase 3
Date of First Enrollment (India)
05/08/2024
Date of Study Completion (India)
25/06/2024
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global)
Completed
Recruitment Status of Trial (India)
Completed
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
Primary dysmenorrhea, characterized by painful menstrual cramps without underlying pathology, it often leads to discomfort, reduced quality of life. Conventional treatments, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and oral contraceptives,It can have adverse effects.Therefore, there is a pressing need for alternative therapies that are both effective and have a favorable safety profile.
The traditional system of medicine in India, offers various remedies for dysmenorrhea, one of which is Jeeraka Churna (Cumin seed powder). It is known for its potential anti-inflammatory and analgesic properties, which might help alleviate the symptoms of primary dysmenorrhea. Additionally, Integrated Yoga Therapy, which combines physical postures, breathing exercises, and meditation, has been shown to improve overall health and reduce stress, which could potentially mitigate the severity of menstrual pain.This study aims to compare the efficacy of Jeeraka Churna and Integrated Yoga Therapy in the management of Udavartini Yonivyapad (Primary Dysmenorrhea).
By conducting an open label double arm randomised controlled clinical study to compare the efficacy of Jeeraka churna and integrated yoga therapy in udavartini yonivyapad, primary dysmenorrhea, in age group of 18-25 years. During the study period 60 patients will be recruited and divided into 3 groups. Group A (Trail group) with oral administration of Jeeraka churna - 1.5g BD dosage with 50 ml of Ushna jala B/F. Group B (Trail group) with suryanamaskara practice for 15 min, 5min of Pranayama followed by 10min of Yoga nidra during non menstrual days and practice of Yoga nidra alone for 10min in the morning hours. Group C (Control group) with oral administration of Tab. Mefenamic acid 250mg in BD dosage during first 3days of menstruation. Statistical analysis will be done on 1st day, 30th day, 60th day and 90th day of menstrual cycle.The outcomes of this research could offer valuable insights into non-pharmacological and holistic approaches to managing primary dysmenorrhea, potentially providing new treatment options that are safe, effective, and accessible.