| CTRI Number |
CTRI/2018/03/012818 [Registered on: 23/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/03/2018 |
| 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 effect of drug VAEPPAM PATTAI KUDINEER for THANDAGA VATHAM(Lumbar Spodylosis) |
|
Scientific Title of Study
|
A prospective open labeled randomized clinical trial on "Thandaga Vatham"(Lumbar Spondylosis) with evaluation of trial drug "Veppam Pattai Kudineer" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JENSIN BRINTHA L |
| Designation |
PG STUDENT |
| Affiliation |
|
| Address |
PG THIRD YEAR
DEPARTMENT OF POTHUMARUTHUVAM
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI
TIRUNELVELI
TAMILNADU
INDIA
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8056685300 |
| Fax |
|
| Email |
ljbrintha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T KOMALAVALLI MD PhD |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI |
| Address |
DEPARTMENT OF POTHUMARUTHUVAM
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI
TIRUNELVELI
TAMILNADU
INDIA
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T KOMALAVALLI MD PhD |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI |
| Address |
DEPARTMENT OF POTHUMARUTHUVAM
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI
TIRUNELVELI
TAMILNADU
INDIA
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Library
Govt Siddha Medical College and Hospital Palayamkottai
|
| Opd and Ipd
Government Siddha Medical College and Hospital Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Dr S NEELAVATHI MD PhD |
| Address |
PRINCIPAL
DEPARTMENT OF POTHUMARUTHUVAM
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI
TIRUNELVELI
TAMILNADU |
| 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 |
| JENSIN BRINTHA L |
Government Siddha Medical College and hospital |
Opd Room number 10
PG Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU |
8056685300
ljbrintha@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 |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
VAEPPAM PATTAI KUDINEER |
50ml BD orally for 30 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms of low back ache radiating to buttocks and lower limbs Pain aggrevated by forward bending Numbness in the lower extremities |
|
| ExclusionCriteria |
| Details |
Patients with Systemic Hypertension Diabetes mellitus Cardiac disease Autoimmune diseases like Rheumatoid arthritis SLE Psoriasis Congenital spinovertebral deformities Liver disease Pregnancy and lactating mother Renal diseases Tuberculosis in spine |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Therapeutic efficacy of trial drug Vaeppam Pattai Kudineer for Thandaga Vatham |
30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Siddha diagnostic parameters Safety of trial drug Pharmacological and Biochemical analysis of trial drug |
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)
|
11/09/2017 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 Randomized clinical study to evaluate the therapeutic efficacy of VAEPPAM PATTAI KUDINEER 50ml BD for 30 days in 40 patients during the trial period of 12 months that will be conducted in Govt Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu The primary outcome will be the therapeutic efficacy of trial drug VAEPPAM PATTAI KUDINEER for THANDAGA VATHAM The secondary outcome will be the evaluation of Siddha diagnostic parameters Safety of trial drug Pharmacological and Biochemical analysis of trial drug |