| CTRI Number |
CTRI/2025/04/085600 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [Siddhar Yogam] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Siddhar yogam with and without Vilvathy Legiyum in the Management of Lumbar Spondylosis |
|
Scientific Title of Study
|
Evaluation of the Therapeutic Effect of Siddhar Yogam with and without Vilvathi Legiyum in the management of Thandagavadham (Lumbar Spondylosis) in Patients Reporting at Ayothidoss Pandithar Hospital, National Institute of Siddha, - A Randomized, Double Arm, Single Centric Comparative 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 V R Manobala |
| Designation |
Postgraduate Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 13 Department of Siddhar Yoga Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9994967103 |
| Fax |
|
| Email |
vrmanobala25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mahalakshmi |
| Designation |
Professor & Head of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 13 Department of Siddhar Yoga Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444519975 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Mahalakshmi |
| Designation |
Professor & Head of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 13 Department of Siddhar Yoga Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444519975 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram Sanatorium- 600047 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha Tambaram Sanatorium- 600047 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 V R Manobala |
National Institute of Siddha |
Room no 13, Department of Siddhar Yoga Maruthuvam OPD National Institute of Siddha Tambaram Sanatorium Chennai 600047
Kancheepuram
TAMIL NADU |
9994967103
vrmanobala25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M47||Spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A - Siddhar Yogam |
Aasanas
Padahastasanam 2 minutes
Balasanam 2 minutes
Bhoominamaskaaram 2 minutes
Jadara parivarthini 2 minutes
Bhavanamukthasanam 2 minutes
Makrasanam 2 minutes
Shanthiasanam 2 minutes
Pranayamam:
Thirumoolar pranayamam - 5 minutes
Dhiyanam with Mudra:
Vaayu mudra - 2 minutes for 48 days |
| Intervention |
Group B Vilvathy Legiyum and Siddhar Yogam |
Vilvathi Legiyum 10 Gms (Kottaipakalavu) (twice a day after food) and Aasanas Padahastasanam 2 minutes Balasanam 2 minutes Bhoominamaskaaram 2 minutes Jadara parivarthini 2 minutes Bhavanamukthasanam 2 minutes Makrasanam 2 minutes Shanthiasanam 2 minutes Pranayamam: Thirumoolar pranayamam - 5 minutes Dhiyanam with Mudra: Vaayu mudra - 2 minutes for 48 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Oswestry Disability index score 15 - 24 |
|
| ExclusionCriteria |
| Details |
K/C/O Uncontrolled Hypertension
K/C/O Rheumatoid arthritis
K/C/O Uncontrolled diabetes
K/C/O Cardiac disorders
K/C/O Osteoporosis
Pregnancy and lactation
Tuberculosis in spine
Osteomyelitis
Ankylosing spondylitis
Spine deformity
Pyogenic bone infection
Patients with recent surgical and traumatic history |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome of the study will assessed by using Oswestry Disability index and expected
reduction in the score will interpreted as
Moderate disability (15-24) to Mild disability (5-14)-Moderate improvement
Moderate disability (15-24) to No disability (0-4)-Significant improvement |
Baseline, once in 7 days upto 49th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/05/2025 |
| Date of Study Completion (India) |
Date Missing |
| 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)
|
Not Applicable |
| 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
|
Lumbar spondylosis is a common degenerative condition affecting a significant population, causing pain, disability, and reduced quality of life. Yoga is generally believed to improve flexibility, strength, balance, and agility. Most people experience low back pain at some point in their lives. The peak in the number of cases occurs at 50–55 years, and women experience low back pain more frequently than men. The prevalence and disability impact of low back pain are greatest among older people aged 80–85 years. For patients with low back pain yoga appears to address imbalances in the musculoskeletal system affecting spinal alignment and posture. Yoga has been shown to reduce chronic low back pain and disability in patients with lumbar spondylosis. Regular practice improves spinal flexibility and strength, enhancing functional ability. Recent research has also indicated that yoga can reduce pain catastrophizing, increase pain acceptance and improve overall emotional functioning among individuals with chronic pain. The raw drugs used in Vilvathi Legiyum has Anti- Inflammatory , analgesic, antioxidant, hepatoprotective, immunomodulatory activities. This study aims to study the effect of Siddhar Yogam with and without Vilvathi Legiyum for the management of Lumbar spondylosis (Thandagavadham) by using Oswestry Disability Index. As per the inclusion criteria, 40 patients will be included in this trial. The selected patients will be divided into two groups. Group A: Siddhar Yogam for 20 patients Group B: Siddhar Yogam and Vilvathi Legiyum for 20 patients.I nformed consent will be obtained from each patient. Group A Patients will be taught selected Siddhar Yogam and for Group B patients the trial drug Vilvathi Legiyum 140 gms will be given once in 7 days and Siddhar Yogam will be taught and advised to follow for 48 days. |