| CTRI Number |
CTRI/2025/05/086153 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Siddha Other (Specify) [Varmam therapy] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
KODUVELI NEI AND VARMAM THERAPY IN THE MANAGEMENT OF THANDAGA VAATHAM (LUMBAR SPONDYLOSIS) - PRE-CLINICAL AND CLINICAL STUDY |
|
Scientific Title of Study
|
EVALUATION OF THE THERAPEUTIC EFFECTIVENESS OF KODUVELI NEI AND VARMAM THERAPY IN THE MANAGEMENT OF THANDAGA VAATHAM (LUMBAR SPONDYLOSIS) - PRE-CLINICAL AND CLINICAL STUDY |
| 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 K Vishnu Priya |
| Designation |
Ph.D Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No.: 15, Department of Varma Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kanchipuram, Tamil Nadu.
Kancheepuram TAMIL NADU 600047 India |
| Phone |
7811802844 |
| Fax |
|
| Email |
vishnubsms1995@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M V Mahadevan |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Pura Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kanchipuram, Tamil Nadu.
Kancheepuram TAMIL NADU 600047 India |
| Phone |
9789633690 |
| Fax |
|
| Email |
mvmresearch2008@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr M V Mahadevan |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Pura Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kanchipuram, Tamil Nadu.
Kancheepuram TAMIL NADU 600047 India |
| Phone |
9789633690 |
| Fax |
|
| Email |
mvmresearch2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai - 47. |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai - 47. |
| 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 K Vishnu Priya |
National Institute of Siddha |
Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai - 47. Kancheepuram TAMIL NADU |
7811802844
vishnubsms1995@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: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Arumuga chenduram with Thirikadugu chooranam - internal
Laguvidamusti thylam - external |
The above mentioned internal and external medication will be given for 28 days |
| Intervention |
Koduveli nei and Varmam therapy |
Koduveli Nei will be given internally foe 9 days.
3 days of drug holiday
followed by it 15 days Varmam therapy |
| Comparator Agent |
Varmam therapy |
Varmam therapy for 28 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having two or more clinical symptoms
I.Pain in the lumbar region and pain increased in forward bending
II.Radiating pain to buttocks and lower limbs
III.Stiffness in the lumbar region
IV.Increase in the pain on movements
V.Numbness (Tingling sensation) in the lower limbs
Grade I & II in the radiological findings of lumbar spine
Patient who are willing to involve in the study by signing the consent and fulfilling the condition of performa, who are willing to undergo radiological and blood investigations.
Patient who has Oswestry low back disability questionnaire total score 5-34
|
|
| ExclusionCriteria |
| Details |
•K/C/O Cardiovascular disease.
•K/C/O Autoimmune disease
•K/C/O spinal deformities
•K/C/O of renal diseases
•K/C/O Tuberculosis and other infections in the spine
•H/O Acute trauma/fracture
•Pregnancy and lactating mothers
•Patients with any other serious systemic illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The treatment is considered as effective by the reduction of 9 points in the score measured using Oswestry Lowback Disability Scale. |
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the effectiveness of drug and Varmam therapy in reducing the clinical
symptoms in groups 1 and 2 compared with Standard control (Group 3)
The adverse reactions will be noted in the Adverse Drug reaction form and reported to
the Pharmacovigilance wing in the hospital.
|
|
|
|
Target Sample Size
|
Total Sample Size="138" Sample Size from India="138"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
13/05/2025 |
| 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="0" 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
|
The aim of the study is to evaluate the preclinical safety, efficacy and therapeutic effectiveness of Koduveli
nei and Varmam therapy in the management of Thandaga vaatham (Lumbar spondylosis)
with the Oswestry low back disability questionnaire scoring 5 - 34 through randomized
controlled clinical trial. After completing the acute and sub-acute toxicity studies of the trial drug, 138 selected patients will be allotted in the study group 1, 2 and 3 through computer generated randomization and envelope concealment allocation method.
Before starting the treatment, purgation with Agasthiyar kulumbu – 130 mg at early
morning in empty stomach with inji saaru (Ginger juice) will be given for balancing the
deranged Uyir thathu and advised to take rest on next day.
For Group 1 patients, the patient is treated with Koduveli nei internally for 9 days and
then advised patient advised to take oil bath and pathiyam. Followed by this, the Varmam
therapy will be given for the patients for 15 days. For Group 2 patients, the Varmam therapy
will be given for the patients for 28 days.For Group 3 patients, Arumuga chenduram
(internally) and Laguvidamusti thylam (externally) is given. The patients who fail to come
regularly for more than 3 days will not be allowed to continue the trial and withdrawn from
the study. Weekly once, the clinical assessment and prognosis will be noted in the prescribed
proformas. The assessment and other clinical data capturing will be done in the presence of
guide and in the supervision of Head of the Department. Laboratory Investigations and
Oswestry low back disability Questionnaire will be performed before and after the trial. After
the completion of trial period the patients will be advised to visit the OPD for further follow
up for two months. |