| CTRI Number |
CTRI/2022/06/043139 [Registered on: 09/06/2022] Trial Registered Prospectively |
| Last Modified On: |
25/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Efficacy of SVK in the treatment of Psoriasis |
|
Scientific Title of Study
|
A randomized controlled trial to determine the safety and
efficacy of Sivanarvembu Kuzhithailam (SVK) in 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 Rathinamala |
| Designation |
Research Officer (S) |
| Affiliation |
Siddha Regional Research Institute |
| Address |
Siddha Regional Research Institute
(Central Council Research in Siddha Ministry of AYUSH Govt of India)
Chellaperumal Street Kuyavarpalayam
Puducherry
India
Chellaperumal Street Kuyavarpalayam
Pondicherry
PONDICHERRY
605013
India |
| Phone |
9445237368 |
| Fax |
|
| Email |
drrmala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rathinamala |
| Designation |
Research Officer (S) |
| Affiliation |
Siddha Regional Research Institute |
| Address |
Siddha Regional Research Institute
(Central Council Research in Siddha Ministry of AYUSH Govt of India)
Chellaperumal Street Kuyavarpalayam
Puducherry
India
Chellaperumal Street Kuyavarpalayam
Pondicherry
PONDICHERRY
605013
India |
| Phone |
9445237368 |
| Fax |
|
| Email |
drrmala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rathinamala |
| Designation |
Research Officer (S) |
| Affiliation |
Siddha Regional Research Institute |
| Address |
Siddha Regional Research Institute
(Central Council Research in Siddha Ministry of AYUSH Govt of India)
Chellaperumal Street Kuyavarpalayam
Puducherry
India
Chellaperumal Street Kuyavarpalayam
Pondicherry
PONDICHERRY
605013
India |
| Phone |
9445237368 |
| Fax |
|
| Email |
drrmala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Siddha, Chennai |
|
|
Primary Sponsor
|
| Name |
The Director General |
| Address |
Central Council for Research in Siddha
Arignar Anna Government Hospital Campus
Arumbakkam
Chennai 106 |
| Type of Sponsor |
Research institution |
|
|
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 Rathinamala |
Siddha Regional Research Institute |
Room no 2, clinical Department
Chellaperumal street,
Kuyavarpalayam,
Puducherry
605013.
Pondicherry
PONDICHERRY |
9445237368
drrmala@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sivanarvembu Kuzhithailam |
First arm will receive Sivanarvembu Kuzhithailam 5 drops BD internally for 90 days |
| Intervention |
Sivanarvembu Kuzhithailam with Vetpalai Thailam |
Third arm will receive Sivanarvembu Kuzhithailam 5 drops BD internally and Vetpalai Thailam externally for 90 days |
| Comparator Agent |
Vetpalai Thailam |
Second arm will receive Vetpalai Thailam externally for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Well defined nonindurated dry erythematous lesions with scaling
A minimum PASI score of 12.0 at screening
Psoriasis covering ≥ 10% of total BSA
Dermatology life quality index (DLQI) score at least 4
Duration of disease at least 6 months
Plaque psoriasis clinically stable for at least 3 months prior to screening
Body weight ≤ 100 kg
|
|
| ExclusionCriteria |
| Details |
Guttate, erythrodermic, or pustular psoriasis
Clinically significant psoriasis flare during screening or at the time of enrolment
History of any secondary skin infection
Pregnancy or lactation
Patients undergoing treatment for chronic illness Diabetes mellitus, Cardiovascular diseases, Tuberculosis, Hypertension etc
Patient with a history of alcohol or drug abuse
Candidate who had been previously treated (e.g., cyclosporine, corticosteroids, methotrexate)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
No significant variation in the haematological, biochemical parameters.
PASI Score: Response status at the end will be determined as follows:
Responder: Any subject whose PASI score decreased ≥ 50% from day 0 to day 46 and day 91.
Partial responder: Any subject whose PASI score decreased ≥ 30% but 50% from day 0 to day 46 and day 91.
Non-responder: Any subject whose PASI score decreased 30% from day 0 to day 46 and 91st day.
|
0th day to 46th and 91st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dermatology Life Quality Index: Any subjects whose DLQI score increase 4 points and above.
Mode of action can be simulated
|
0th day to 46th and 91st day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/06/2022 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A randomized controlled trial to determine the safety and efficacy of Sivanarvembu Kuzhithailam (SVK) in the management of Kalanjagapadai (Psoriasis) This study has been planned to assess the safety and efficacy of the trial drugs in the management of Kalanjagapadai (Psoriasis). It is a triple arm trial with 30 participants in each group. The trial drugs will be administered for a period of 3 months with 6 months follow up period. The first arm will be receiving Sivanarvembu Kuzhithailam with Sivanarvembu chooranam internally, second group will be receiving Vetpalai thailam externally and the third group will be receiving Sivanarvembu Kuzhithailam internally and Vetpalai thailam externally. The study has been approved by the IHEC of SRRI, Puducherry. Study participants are recruited from March 2023. Now recruitment is in progress. |