| CTRI Number |
CTRI/2017/06/008923 [Registered on: 28/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
24/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical research of siddha medicine in the management of Psoriasis (Kalanjagapadai) |
|
Scientific Title of Study
|
An open clinical trial of Siddha drug Karunchoorai chooranam (Internal medicine) and Kodiveli Thylam (External Medicine) in the treatment 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 S P Kopperundevi |
| Designation |
PG scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Sirappu Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8056987496 |
| Fax |
|
| Email |
dr.kopperundevipitchai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mahalakshmi |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Sirappu Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444519975 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S P KOPPERUNDEVI |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPARTMENT OF SIRAPPU MARUTHUVAM
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI 600047 TAMILNADU INDIA
DEPARTMENT OF SIRAPPU MARUTHUVAM
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI 600047 TAMILNADU INDIA
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8056987496 |
| Fax |
|
| Email |
dr.kopperundevipitchai@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram sanatorium
Chennai 600047 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha Tambaram Sanatorium Chennai600047 |
| 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 S P Kopperundevi |
National institute of siddha |
Room No 3, Department of Sirappu maruthuvam, Ayothidoss Pandithar Hospital,
National Institute of Siddha Tambaram sanatorium
Chennai 47
Kancheepuram
TAMIL NADU |
8056987496
dr.kopperundevipitchai@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 |
karunchoorai chooranam (internal) kodiveli thylam ( external) |
2 gram of karunchoorai chooranam will be adminstered orally twice a day, 50 ml of kodiveli thylam (external) will be issued 50 ml to apply the affected areas of skin for a period of 48 days. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Erythema
2.Thickness
3.Scaling
4.Itching; with or without itching
5.Auspitz sign +
6.Candle crease sign + |
|
| ExclusionCriteria |
| Details |
1.Psoriatic arthropaty
2.pregnancy and lactation
3.Psoriasis with evidence of any other skin disease
4.Evidence of secondary infection
5.Leprosy
6.Systemic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
GOOD OUTCOME-Clearence of lesions and reduction of PASI score from 3,4 to 1,2
MODERATE OUTCOME- Partial clearence of lesions and reduction of PASI score from 3,4 to 1,2
POOR/NIL-No clearence of lesions or no reduction of PASI Score |
48 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)
|
01/03/2017 |
| 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
|
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-randomised , open label trial to determine the therapeutic efficacy of KARUNCHOORAI CHOORANAM (prepared from herbal constituents) in patients with PSORIASIS (KALANJAGAPADAI). Karunchoorai chooranam consists of Capparis sepiaria, Plumbago indica, Enicostemma axillare, Toddalia asiatica, Piper nigrum, Gymnema sylvestre, Corallocarpus epigaeus, Acaci anilotica and Stercularia foedita. All the ingredients are purified, powdered and stored in an air tight container.In this trial 40 patients will be recruited and the trial drug will be administered 2 gram twice a day for a period of 48 days. During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmaco vigilance department 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 efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. The outcome of this trial will be published in Indian Journal of Medical Research. |