| CTRI Number |
CTRI/2024/10/074878 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Siddha |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effects of Yoga Practices and Varma Therapy on selected variables among Middle Aged Men with Low Back Pain |
|
Scientific Title of Study
|
Efficacy of Yoga Sadhana and Varma Therapy on selected variables among Middle Aged Men with Thandaga Vatham |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sivakumar S |
| Designation |
PhD Scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Department: Faculty of Yoga Science and Therapy
Division: 3rd Floor
Room No: 303
No. 12 Vembuliamman Koil Street, West K K Nagar, Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9444749969 |
| Fax |
|
| Email |
sivakumar0018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. D. Uma Maheswari |
| Designation |
Assistant Professor |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Department: Faculty of Yoga Science and Therapy
Division: 3rd Floor
Room No: 303
No. 12, Vembuliamman Koil Street, West K K Nagar, Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
7708022722 |
| Fax |
|
| Email |
shiny.uma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sivakumar S |
| Designation |
PhD Scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Department: Faculty of Yoga Science and Therapy
Division: 3rd Floor
Room No: 303
No. 12, Vembuliamman Koil Street, West K K Nagar, Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9444749969 |
| Fax |
|
| Email |
sivakumar0018@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Academy of Higher Education and Research, (Deemed to be University)
No.12, Vembuliamman Koil Street, West K K Nagar, Chennai, Tamil Nadu, India - 600078 |
|
|
Primary Sponsor
|
| Name |
Sivakumar S |
| Address |
Faculty of Yoga Science and Therapy, Meenakshi Academy of Higher Education and Research, No. 12,Vembuliamman Koil Street, West K K nagar, Chennai - 600078 |
| 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 |
| Dr Uma Maheswari |
Meenakshi Academy of Higher Education and Research |
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 3030
No. 12, Vembuliamman Koil Street, West K K Nagar, Chennai 600078
Chennai
TAMIL NADU |
7708022722
shiny.uma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE MEENAKSHI ACADEMY OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Yoga Sadhana |
Asana, pranayama, meditation,
mudras, chanting would be
used and modified according to the needs.
Frequency : 5 times a Week Total
Duration : 3 Months |
| Intervention |
Group B: Varma Therapy |
Varmam medicine is the Siddha System of Medicine’s, Contributed by the Siddhars for the benefit of mankind. Siddha medicine, one of Indias oldest indigenous systems, contains a
library of traditional formulations for internal use and a variety of additional distinct techniques/therapies for external use.
Frequency : 5 times a Week Total Duration : 3 Months |
| Comparator Agent |
Group C : Yoga Sadhana and Varma Therapy |
Asanas, Pranayama, Mudras will be given in Yoga Sadhana. Varmam medicine is the Siddha System of Medicine’s, Contributed by the Siddhars for the benefit of mankind. Siddha medicine, one of Indias oldest indigenous systems, contains a
library of traditional formulations for internal use and a variety of additional distinct techniques/therapies for external use.
Frequency : 5 times a Week Total Duration : 3 Months |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. The subject will be delimited to men only.
2. The subject will be delimited to middle aged men between age group 35 to 50 years only.
3. The study will be delimited to Chennai district only.
4. The dependent variables will be Physical, Radiological and Psychological only.
5. Total subjects considered for this research delimited to 180 only. |
|
| ExclusionCriteria |
| Details |
1. The study will be limited to changing life style condition
2. The study will be limited to climatic condition.
3. The study will be limited to person taking medication for thandaga vatham.
4. The study will be limited to person already doing yoga.
5. The study is included limited yoga practices and varma therapy without any diet restrictions.
6. The study is limited to men who have given consent form.
7. The study will be limited to socio economic condition.
8. The subject will be limited to those who undergone surgery, bone fracture or any severe complications.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Sit and Reach Test
2. Y-Angle Test
|
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. CT-Scan
2. Pain management Questionnaire
3.Quebec Back Pain Disability Scale
4. Oswestry Disability Index |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
15/10/2024 |
| 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 Yet Recruiting |
| 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
|
This study would be conducted for the partial fulfilment of the Ph.D Study at Meenakshi Academy of Higher Education and Research (Deemed to be University), Chennai.
In Middle age men, the thandaga
vatham (low back pain) condition is raising slowly due various reasons. The men between the ages of 35 to 50 years
were selected for the study. More than 200 subjects were screened and around 90 subjects were tested with thandaga vatham
condition. With the consent of the subjects,
90 were taken for the study which is divided equally in Experimental group - A
(n=30) with the yoga sadhana,
Experimental group - B (n= 30) with the Varma therapy and Experimental group -
C (n=30) with the yoga sadhana and Varma therapy. The
parameters such as Sit and Reach test, Y-Angle Test, CT-Scan, Pain
management Questionnaire, Quebec Back Pain Disability Scale, Oswestry
Disability Index are to be analysed.
The subjects were proposed to give 12 weeks of practice, 5 days a week for 60
minutes a day. The Yoga and Varma
practice will give the significant changes after the post-test from the pre- test. |