| CTRI Number |
CTRI/2023/05/053319 [Registered on: 31/05/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [Varmam Massage] |
| Study Design |
Other |
|
Public Title of Study
|
TO COMPARE THE EFFICACY OF VARMA MASSAGE WITH TIRI RAATCHATHA CHOORANAM (INTERNAL) AND MUKUTTU ENNAI (EXTERNAL) IN THE MANAGEMENT OF CERVICAL SPONDYLOSIS |
|
Scientific Title of Study
|
AN OPEN LABELLED DOUBLE ARM NON-RANDOMISED PHASE II CLINICAL TRIAL, TO COMPARE THE EFFICACY OF VARMA MASSAGE WITH TIRI RAATCHATHA CHOORANAM (INTERNAL) AND MUKUTTU ENNAI (EXTERNAL) IN THE MANAGEMENT OF PIDARI VATHAM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
THAMIZH PRIYAN |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha medical college and hospital palayamkottai |
| Address |
Department of Varma Maruthuvam
Government Siddha medical college and Hospital
Palayamkottai
Department of Varma Maruthuvam
Government Siddha medical college and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8903119931 |
| Fax |
|
| Email |
thamizh0999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Muneeswaran |
| Designation |
Associate Professor |
| Affiliation |
Government Siddha medical college & Hospital, Palayamkottai. |
| Address |
Department of Varma Maruthuvam
Government Siddha medical college and Hospital
Palayamkottai
Department of Varma Maruthuvam
Government Siddha medical college and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443724897 |
| Fax |
|
| Email |
ameswar1968@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Muneeswaran |
| Designation |
Associate Professor |
| Affiliation |
Government Siddha medical college & Hospital, Palayamkottai. |
| Address |
Department of Varma Maruthuvam
Government Siddha medical college and Hospital
Palayamkottai
Department of Varma Maruthuvam
Government Siddha medical college and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443724897 |
| Fax |
|
| Email |
ameswar1968@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha medical college and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr S THAMIZH PRIYAN |
| Address |
II year PG scholar Department of Varma Maruthuvam
Government Siddha medical college and Hospital
Tirunelveli 627002 |
| 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 |
| Thamizh priyan |
Government Siddha medical college and Hospital |
Department of Varma Maruthuvam
Government Siddha medical college and Hospital
Tirunelveli
TAMIL NADU |
8903119931
thamizh0999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tiri Raatchatha Chooranam(Internal)
Mukuttu Ennai(External application)
|
Tiri Raatchatha Chooranam- 1Gm TDS (41 Days)
Mukuttu Ennai–External application.
|
| Intervention |
Varmam massage |
External Stimulation of varmam
By Traditional Varma Massage for 7 Days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Pain in the nape of the neck
With or without numbness and pain in the upperlimbs
Neck stiffness
Giddiness
Patient who are willing for admission and stay in IPD or willing to attend OPD.
Patient willing to sign Informed consent document
|
|
| ExclusionCriteria |
| Details |
History of Trauma/Neck surgery
Neoplasm tuberculosis in spine
severe osteoporosis of cervical spine
congenital anomalies of spine
Ankylosing spondylosis
Pregnant women and lactating mothers
Patient with any other serious systemic illness
Syringomyelia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease the intensity of pain |
clinical assessment after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare between Group I and II |
Outcome will be assed at 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/06/2023 |
| Date of Study Completion (India) |
01/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an open labelled Double arm Non-Randomised phase-II Clinical trial to compare the Efficacy of VARMA MASSAGE with TIRI RAATCHATHA CHOORANAM (Internal medicine) MUKUTTU ENNAI (External medicine) in the treatment of PIDARIVATHAM TIRI RATCHATHA CHOORANAM Dosage 1GM thrice daily MUKUTTU ENNAI applied over the affected areas of the body. |