| CTRI Number |
CTRI/2018/04/012990 [Registered on: 03/04/2018] Trial Registered Prospectively |
| Last Modified On: |
03/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to study the drug Munnai ilai kudineer on vatham |
|
Scientific Title of Study
|
A prospective open labelled non randomized phase II clinical trial to assess the therapeutic efficacy of the Siddha formulation Munnai ilai kudineer for the treatment of Thandaga Vatham (Lumbar Spondylosis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Prakash |
| Designation |
PG Student |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Department of Pothumaruthuvam Government Siddha Medical college and hospital palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9578563300 |
| Fax |
|
| Email |
drprakashbsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Manoharan MD Siddha |
| Designation |
Head of the Department and Professor |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Department of Pothumaruthuvam Government Siddha Medical college and hospital palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
04622582010 |
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Komalavalli MD Siddha PhD |
| Designation |
Associate professor |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Department of Pothumaruthuvam Government Siddha Medical college and hospital palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
04622582010 |
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material support Library Government Siddha Medical college and hospital Palayamkottai Tirunelveli 627002 Tamilnadu India |
| OPD and IPD Government Siddha Medical college and hospital palayamkottai Tirunelveli 627002 Tamilnadu India |
|
|
Primary Sponsor
|
| Name |
Dr R Neelavathy |
| Address |
Principal
Government Siddha Medical college and hospital Palayamkottai Tirunelveli 627002 Tamilnadu India |
| Type of Sponsor |
Government medical college |
|
|
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 N Prakash |
Government Siddha Medical College |
Opd room 10 PG pothumaruthuvam Government Siddha Medical college and hospital Palayamkottai Tirunelveli 627002 Tamilnadu India
Tirunelveli
TAMIL NADU |
9578563300
drprakashbsms@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 |
Thandaga Vatham, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Munnai ilai Kudineer |
30ml twice time per day |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with low back pain with radiography of lumbosacral spine showing
Loss of natural lumbar lordosis
Reduction in disc space
Osteoporosis
Subluxation of vertebra |
|
| ExclusionCriteria |
| Details |
Diabetes mellitus
Auto immune diseases like sle
Chronic kidney disease
Fracture of Spine
Tuberculosis of spine
Congenital spino vertebral deformities
Cardiac disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The therapeutic efficacy of trial drug munnai ilai kudineer on Thandaga Vatham |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Siddha diagnostic parametes |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
16/04/2018 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Study is A prospective open labelled phase II non randomized clinical trial to evaluate the therapeutic efficacy of munnai ilai kudineer for the treatment of Thandaga Vatham 30ml daily twice time per day for 30 days in 40 patients during the trial period of 18 months that will be conducted in government siddha medical college and hospital palayamkottai tirunelveli tamilnadu the primary out come will be the therpeutic efficacy of trial drug munnai ilai kudineer on Thandaga Vatham The Secondary outcome will be the evaluation of siddha diagnostic parameters |