| CTRI Number |
CTRI/2018/03/012548 [Registered on: 13/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
09/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of trial drug OMA LEGIUM (Internal) THAGARAI LEBAM(External)on Kalanjagapadai(Psoriasis) |
|
Scientific Title of Study
|
An Open Clinical Study to evaluate the clinical efficacy of siddha sasthric formulation "OMA LEGIYAM"(Internal)"THAGARAI LEBAM" for the treatment of Kalanjagapadai. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T Murugavel |
| Designation |
Pg Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Pg Sirappu Maruthuvam
Government Siddha Medical College
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
drtmurugavel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Ahamed mohideen |
| Designation |
Assistant professor |
| Affiliation |
Government Siddha Medical College |
| Address |
Pg Sirappu Maruthuvam
Government Siddha Medical College
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
dr.ahamed63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Murugavel |
| Designation |
Pg Student |
| Affiliation |
Government Siddha Medical College |
| Address |
Pg Sirappu Maruthuvam
Government Siddha Medical College
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
drtmurugavel@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD of government siddha medical college.
Library of government siddha medical college
|
|
|
Primary Sponsor
|
| Name |
Dr S Neelavathi |
| Address |
Principal
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli |
| 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 T Murugavel |
Government siddha medical college and hospital |
Op No 4
Pg Sirappu maruthuvam Department
Tirunelveli
TAMIL NADU |
9629951573
drtmurugavel@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 |
Itching
silvery scaling, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not ApplicABLE |
NOT APPLICABLE |
| Intervention |
Oma legium (Internal)
Thagarai Lebam(External) |
Oma legium 1 Kazhanju(5.1gram)with milk
Thagarai Lebam sufficient amount(External)for 48 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
silvery scaly patches
coin shaped lesion
willing for admission and study in IPD 14 days or willing to OPD |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation
Hypertension
Cardiac problems
Use narcotic drugs
Diabetes mellitus
Tuberculosis
Malignancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced Scalling and itching |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Siddha Diagnostic Parameters |
48 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)
|
05/09/2017 |
| 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="6"
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
|
Phase II
criteria based clinical study to evaluate the clinical efficacy of siddha herbo
mineral formulation of oma legiyam 1 gram Bd wtth milk (Internal)
and Thagarai lepam sufficient amount(External) on Kalanjaga padai(Psoriasis) for 48
days in 40 patients during the trial period of 1 year 6 months that will
be conducted in government siddha medical college palyamkottai tamil nadu the
primary out come is reducing the clinical symptoms of scaling and Itching of trail drug oma legiyam (Internal) and Thagarai lepam
(external) the secondary outcome will be the Evaluation of siddha diagnostic
parameters.
|