| CTRI Number |
CTRI/2024/06/068474 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on effectiveness of varma drug and varmam for lumbar spondylosis. |
|
Scientific Title of Study
|
An open clinical trial to evaluate the therapeutic efficacy of Varma Kanji (Internal) and Lagu Vishamutti Thylam (External) with Varmam therapy in the management of Thandagavatham (Lumbar Spondylosis) |
| 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 P Gaayathri |
| Designation |
Postgraduate Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of varmam maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9360975192 |
| Fax |
22381314 |
| Email |
gaayathripruthvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR D Periyasami |
| Designation |
Associate Professor HOD (i/c) |
| Affiliation |
National Institute of Siddha |
| Address |
Department of varmam maruthuvam
National Institute of Siddha,
Tambaram Sanatorium,
Chennai.I
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7358481734 |
| Fax |
22381314 |
| Email |
sami2011nis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR D Periyasami |
| Designation |
Associate Professor HOD (i/c) |
| Affiliation |
National Institute of Siddha |
| Address |
Department of varmam maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7358481734 |
| Fax |
22381314 |
| Email |
sami2011nis@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,
Tambaram Sanatorium,
Chennai.
Pincode : 600047
Tamilnadu,
India. |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha,
Tambaram Sanatorium,
Chennai.
Pincode : 600047
Tamilnadu,
India. |
| 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 P Gaayathri |
Ayothidoss Pandithar Hospital |
OPD No - 15
Department of varmam maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai.
Kancheepuram
TAMIL NADU |
9360975192
22381314
gaayathripruthvi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The 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: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Varma Kanji (Internal)
Lagu vishamutti thylam (External)
Varmam therapy |
Internal - 60ml once a day for 48 DAYS
External - 50ml Applied in low back region
Varmam therapy - Once in a week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age : 18 - 60 years
2.Sex: Male, Female and Transgender
3.Score between 40 - 80 % in ABERDEEN LOW BACK PAIN SCALE
4.Patients willing to give radiological investigation and provide blood sample for lab investigation
5.Patient willing to sign Informed Consent |
|
| ExclusionCriteria |
| Details |
1.Ankylosing spondylitis
2.K/C/o Trauma
3.Spondylolisthesis
4.Vertebral fracture
5.Tumour in Lumbar Vertebra
6.K/C/o TB
7.K/C/o Disc Prolapse |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean reduction in pain, numbness & restriction of movements of Thandagavatham patients with trial medicines |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Aberdeen low back pain scale score reduced to 20% |
Screening - 6 months
Patient enrollment - 6 Months
Preparation of trial drug - 2 Months
Data analysis - 1 month
Follow up - 2 Months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/06/2024 |
| 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 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
|
INTRODUCTION : Lumbar spondylosis is a chronic, noninflammatory disease caused by degeneration of lumbar disc and/or facet joints. It is common and worsens with age. In lumbar spondylosis, there is narrowing of the space between the vertebrae, causing a variety of health problems ranging from back pain to neurological issues. Pain or tingling symptoms that extend outward to the hip or down the leg can result from compression or inflammation of nerves, a condition referred to as lumbar radiculopathy. Nowadays, Low back pain is common among people who have sedentary lifestyle, obese, having job related risk factors that require heavy weight lifting, travelling to distant places or maintaining a poor sitting posture. The pooled point, annual, and lifetime prevalence of LBP in India was 48% (95% CI 40-56%); 51% (95% CI 45-58%), and 66%(95%CI 56-75%), respectively. The pooled prevalence rates were highest among females, therural population, and among elementary workers. The point, annual, and lifetime prevalence rates of LBP in the Indian population is higher compared to global and other ethnic populations. MATERIALS AND METHODS : A total of 30 patients within the age limit of 18 - 60 years willing to participate in the study by signing the consent form will be enrolled in the study. Both male and female patients will be enrolled. RESULTS AND DISCUSSION : Reduction of clinical symptoms of lumbar spondylosis through Aberdeen low back pain scale and the results will be statistically analysed. |