| CTRI Number |
CTRI/2014/12/005339 [Registered on: 31/12/2014] Trial Registered Prospectively |
| Last Modified On: |
01/01/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical Research of siddha medicine in the management of kaalaanjagappadai(psoriasis) |
|
Scientific Title of Study
|
SAFETY AND COMPARATIVE OPEN CLINICAL STUDY OF “GANTHI MEZHUGU†(INTERNAL) AND “KUTTA NOIKALUKKU MEL POOTCHU ENNAI†(EXTERNAL) IN THE TREATMENT OF “KAALAANJAGAPPADAI†(PSORIASIS) WITH AND WITHOUT YOGAM 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 R SELVAKUMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI TAMIL NADU
600047
India
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI TAMIL NADU
600047
India
Chennai
TAMIL NADU
600047
India |
| Phone |
7402480757 |
| Fax |
04422381314 |
| Email |
dr.selvakumar7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR N J MUTHUKUMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI TAMIL NADU
600047
India
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI TAMIL NADU
600047
India
Chennai
TAMIL NADU
600047
India |
| Phone |
9444206843 |
| Fax |
04422381314 |
| Email |
njmuthu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR R SELVAKUMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI TAMIL NADU
600047
India
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI TAMIL NADU
600047
India
TAMIL NADU
600047
India |
| Phone |
7402480757 |
| Fax |
04422381314 |
| Email |
dr.selvakumar7@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYOTHIDOSS PANDITHAR HOSPITAL
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM
CHENNAI |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 R SELVAKUMAR |
NATIONAL INSTITUTE OF SIDDHA |
Department of Sirappu maruthuvam National Institute of Siddha chennai
Chennai
TAMIL NADU
Kancheepuram
TAMIL NADU |
7402480757
04422381314
dr.selvakumar7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Kaalaanjagappadai (Psoriasis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ganthi Mezhugu (Internal) and Kutta Noikalukku Mel Pootchu Ennai (External) |
260mg of Ganthi Mezhugu administered orally twice a day for a period of 48 days.Kutta Noikalukku Mel Pootchu Ennai(External)will be issued 50 ml to apply the affected areas of skin. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Erythema
• Thickness
• Scaling
• Ithching :with or without itching
• Auspitz sign +
• Candle crease sign +
• Age : 20-60 years
• Sex : Both male and female
• Willing to give specimen of blood for the investigation whenever required.
• Willing to participate in trial and signing consent by fulfiling the condition of proforma.
|
|
| ExclusionCriteria |
| Details |
• Hypertension
• Diabetes Mellitus
• Narcotic addicts
• Pregnancy and lactation
• Psoriasis with evidence of any other skin disease
• Psoriatic arthropathy
• Cardiac disease
• Leprosy
• Evidences of secondary infection in the lesions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Good outcome –Clearance of lesions and Reduction of PASI Score from 3,4 to 0,1.
Moderate outcome –Partial clearance of lesions and Reduction of PASI Score from 3,4 to 1,2.
Poor/Nil- NO Clearance of lesions or No reduction PASI Score
|
PRE STUDY SCREENING AND AFTER
TREATMENT
|
|
|
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 3 |
|
Date of First Enrollment (India)
|
31/12/2014 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It
is a single, non-randomized, open-label trial to determine the efficacy
and safety of GANTHI MEZHUGU (Prepared from herbo mineral constitutents)
in patients with KAALAANJAGAPPADAI (PSORIASIS). In this trial
40 patients will be recruited and the trial drug will be administered 260mg twice a day for a period of 48 days. During this trial period all the
study related data will be recorded and documented in a page separate
trial master file for each patients.During the trial period if any
AE/SAE/SUSAR will be noticed and referred to pharmacovigilance
dept.in NIS and further management will also
be given in NIS OPD/IPD.The entire trial will be monitored by the
research monitoring committee OF NIS. During this trial all the safety and
efficacy parameters will be recorded in the CRF. After completion of the
trial all the study related data will be analysed statistically .The out
come of this trial will be published in Indian Journal of Medical Research |