| CTRI Number |
CTRI/2017/08/009211 [Registered on: 01/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
31/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An open clinical trial to study the efficacy of Ganthaga rasaayanam in patients having Psoriasis |
|
Scientific Title of Study
|
An open clinical trial to evaluate the therapeutic efficacy of siddha herbo mineral formulation of "Ganthaka Rasaayanam"(Internal medicine) and "Vettiver Thylam"(External medicine) for the management of "Kalanjagapadai"(Psoriasis) |
| 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 Prabakaran |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Dept of Sirappu Maruthuvam, Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9715105196 |
| Fax |
|
| Email |
prabakaranbsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N J Muthukumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Dept of Sirappu Maruthuvam, Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962006843 |
| Fax |
|
| Email |
njmuthu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Prabakaran |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Dept of Sirappu Maruthuvam, Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
|
| Fax |
|
| Email |
prabakaranbsms@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha, Tambaram Sanatorium, Chennai 47 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha, Tambaram Santorium, Chennai 47 |
| 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 PRABAKARAN |
National Institute of Siddha |
Room no 3, Dept of Sirappu Maruthuvam, Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium
Kancheepuram
TAMIL NADU |
9715105196
prabakaranbsms@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 |
KALANJAGAPADAI (PSORIASIS), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ganthaga Rasaayanam (Internal) and Vettiver Thylam (External) |
2 gms of Ganthaga Rasaayanam will be administered orally twice a day with palm jaggery for 40 days. Sufficient quantity of Vettiver Thylam will be given for external application for 40 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Erythema
2.Thickness
3.Silvery scaling
4.Auspitz sign positive
5.Candle crease sign positive
6.Patients willing to give specimen of blood for investigation whenever required
7.Patients willing to take photograph
8.Patients willing to participate in the trial and signing consent by fullfilling the condition of proforma
|
|
| ExclusionCriteria |
| Details |
1.Diabetes mellitus
2.Pregnancy and lactation
3.Psoriasis with evidence of any other skin disease or evidence of secondary infection in the lesion
4.Psoriatic arthropathy
5.Cardiac disease
6.Hansens disease
7.Any other chronic illness
|
|
|
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 2.
Mild- Slight clearancce of lesions and reduction of PASI score from 4 to 3
Nil- NO Clearance of lesions or No reduction PASI Score |
40 Days |
|
|
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)
|
11/02/2016 |
| 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
|
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 of GANTHAKA RASAAYANAM (Prepared from herbo mineral constitutents) in patients with KALANJAGAPADAI (PSORIASIS). In this trial 40 patients will be recruited and the trial drug will be administered 2 gm twice a day for a period of 40 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. 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 |