CTRI Number |
CTRI/2018/05/013644 [Registered on: 03/05/2018] Trial Registered Prospectively |
Last Modified On: |
02/05/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Siddha |
Study Design |
Single Arm Study |
Public Title of Study
|
a study on siddha trail drug KUTTATHIRKU CHOORANAM (INT) & VEPPAMPATTAI THYLAM (EXT) & PRANAYAAMAM (THERAPY) in patients having psoriasis |
Scientific Title of Study
|
AN OPEN CLINICAL TRAIL ON “THEATHRU KUTTAM (PSORIASIS)†WITH THE EVALUATION ON SIDDHA HERBO-MINERAL FORMULATION KUTTATHIRKU CHOORANAM (INT) & VEPPAMPATTAI THYLAM (EXT) & PRANAYAAMAM (THERAPY). |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr K Thirugnanam |
Designation |
PG scholar |
Affiliation |
government siddha medical college chennai |
Address |
Post graduate department of sirappu maruthuvam,
Siddha medical college
no 6 anna arch road, NSK nagar arumbakkam, chennai
Chennai TAMIL NADU 600106 India |
Phone |
8122462463 |
Fax |
|
Email |
rk.thiru73@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr G Sekar |
Designation |
Grade II Lecturer |
Affiliation |
government siddha medical college chennai |
Address |
Room no 4 Department of sirappu maruthuvam
Govt Siddha medical college
no 6 anna arch road NSK nagar, Arumbakkam, Chennai
Chennai TAMIL NADU 600106 India |
Phone |
9786193863 |
Fax |
|
Email |
guidesekar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr K Thirugnanam |
Designation |
PG scholar |
Affiliation |
government siddha medical college chennai |
Address |
Post graduate department of sirappu maruthuvam
siddha medical college
no 6 anna arch road, NSK nagar, Arumbakkam, Chennai
Chennai TAMIL NADU 600106 India |
Phone |
8122462463 |
Fax |
|
Email |
rk.thiru73@gmail.com |
|
Source of Monetary or Material Support
|
government siddha medical college
no 6 anna arch road nsk nagar arumbakkam chennai |
|
Primary Sponsor
|
Name |
government siddha medical college |
Address |
no 6 anna arch road nsk nagar arumbakkam chennai |
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 K Thirugnanam |
arignar anna hospital of indian medicine |
room no 4 siddha division POst graduate department of sirappu maruthuvam
siddha medical college
no 6 anna arch road nsk nagar arumbakkam chennai tamil nadu Chennai TAMIL NADU |
8122462463
rk.thiru73@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional ethical comitee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
THEATHRU KUTTAM (PSORIASIS), |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
KUTTATHIRKU CHOORANAM(INT) & VEPPAMPATTAI THYLAM (EXT) |
8oo mg of KUTTATHIRKKU CHOORANAM for 48 days as internal medicine and Veppampattai thylam (external) for 48 days as external medicine |
Comparator Agent |
nil |
nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patches with Scaling
Auspitz Sign positive
Koebner’s Phenomenon positive.
|
|
ExclusionCriteria |
Details |
Psoriasis with secondary infection in the lesions
Alcoholism & Narcotic addicts
History of long term intake of Steroids
Cardiac disease
Renal failure
Pregnancy women and Lactating women
Peptic ulcer
Psoriatic Orthopedica
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
outcome is mainly assessed by reduction in clinical symptoms like itching and scaling.PASI Score (Psoriasis area severity index) |
12 Months |
|
Secondary Outcome
|
Outcome |
TimePoints |
nil |
nil |
|
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)
|
06/05/2018 |
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="0" 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
|
This is an open clinical study to evaluate the efficacy of KUTTATHIRKU
CHOORANAM (INT) VEPPAMPATTAI THYLAM (EXT) .8oomg of KUTTATHIRKU CHOORANAM and sufficient quantity of VEPPAMPATTAI THYLAM will be given for 48 days. PRANAYAAMAM (THERAPY) is given for all the patients.sample size is 40.the trail drugs KUTTATHIRKU CHOORANAM (INT) VEPPAMPATTAI THYLAM (EXT) contains some herbs and metals having anti-oxidant,immune modulator properties which will be helpful to manage psoriasis |