| CTRI Number |
CTRI/2023/09/057892 [Registered on: 20/09/2023] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the effectiveness of PERUNGAYA LEGIAM (Internal) with LAGU VISHAMUTTI THYLAM (External) in the management of THANDAGAVATHAM (LUMBAR SPONDYLOSIS) |
|
Scientific Title of Study
|
Clinical evaluation of siddha herbal formulation of perungaya legiam (internal)
with lagu vishamutti thylam (external) in the management of thandagavatham (lumbar
Spondylosis) in patients reporting at ayothidoss pandithar hospital , national institute of
siddha, chennai- 600 047 |
| 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 S Niraimathi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9787569186 |
| Fax |
|
| Email |
niraimathi431597@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Nalini Sofia |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8
Department of Maruthuvam National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
|
| Email |
drhnalinisofia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr H Nalini Sofia |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8
Department of Maruthuvam National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
|
| Email |
drhnalinisofia@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram Sanatorium |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room no 7/8
Department of Maruthuvam National Institute of Siddha
Tambaram Sanatorium Kancheepuram Chennai 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 S Niraimathi |
Ayothidoss Pandithar Hospital |
Room no 7/8
Department of
Maruthuvam National
Institute of Siddha
Tambaram Sanatorium
Kancheepuram
Chennai 600047
Kancheepuram
TAMIL NADU |
9787569186
niraimathi431597@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Sidddha |
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 |
| Intervention |
Perungaya legiam (internal)
Lagu vishamutti thylam (external) |
5 g bd
DURATION:48 Days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with symptoms like pain and/or stiffness of the back, pain over the front of the thigh.
2. Willing to give the blood samples for the investigation .
3. Willing to take radiological investigations .
4. Willing to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Known case of Ankylosing spondylitis
2. Uncontrolled Diabetes mellitus.
3. Pregnant and lactating women
4.Known history of Severe injury
5.Not willing to give blood samples for the investigation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of Aberdeen low back pain scale scoring before & after treatment. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2023 |
| Date of Study Completion (India) |
04/06/2024 |
| 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)
Modification(s)
|
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
|
INTRODUCTION: This is a clinical trial that evaluates the effectiveness of siddha formulations
perungaya legiam (internal) with Lagu vishamutti thylam (external) in the management of
Thandagavatham (lumbar spondylosis) patients through Aberdeen low back pain scale. Lumbar
spondylosis is a degenerative disc disease and osteoarthritic change in the lumbar spine.Lumbar
spondylosis occurs as a result of new bone formation in areas where the anular ligament is stressed
.Growth of new bone projecting horizontally at these margins identifies osteophytes. Lumbar
osteophytes have long been thought to cause back pain because of their frequency and size.Lumbar
spondylosis occurs in 6-10% of the general population and has been found to be as high as 25 -60% in
athletes, especially in athletes younger than 18 years who participate in sports that involve twisting or
backward bending motions of the spine. In the United States, more than 80% of individuals older than
40 years have lumbar spondylosis. Lumbar osteophytes have been found to be present in about 20%
of men and 22% of women aged 45-64 years and in 30% of men and 28% of women aged 55-64
years.So my aim is to treat thandagavatham with siddha medicines.
OBJECTIVE: • To assess the effectiveness of PERUNGAYA LEGIAM (Internal) with LAGU
VISHAMUTTI THYLAM (External) in the management of
THANDAGAVATHAM (LUMBAR SPONDYLOSIS) by using Aberdeen
low back pain scale before and after treatment . • The standardization of the trial drug will be done as per PLIM guidelines.
MATERIALS AND METHODS: A total of 30 diagnosed patients of thandagavatham within the age limit of 18
to 60 years willing to particupate in the study , by signing the consent form will be enrolled in the
study . Having Ankylosing spondylitis, Tuberculosis ,Hypertension ,Diabetes mellitus ,Cardiac
disease and renal diasease ,Pregnant and lactating women, history of Severe injury will be excluded
from the study. Assesssment will be done by using Aberdeen low back pain scale pre and post
treatment.
RESULTS AND DISCUSSION:
The results will be statistically analysed.
KEYWORDS:
Perungaya legiam ,Lagu vishamutti thylam , Thandagavatham |