Efficacy of SVK in the treatment of Psoriasis

Phase 2

Recruiting

• Conditions: Psoriasis vulgaris,

• Registration Number: CTRI/2022/06/043139
• Lead Sponsor: The Director General

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-15
• Last Update Posted: 2024-05-25

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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.

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
No significant variation in the haematological, biochemical parameters.	0th day to 46th and 91st day
PASI Score: Response status at the end will be determined as follows:	0th day to 46th and 91st day
Responder: Any subject whose PASI score decreased ≥ 50% from day 0 to day 46 and day 91.	0th day to 46th and 91st day
Partial responder: Any subject whose PASI score decreased ≥ 30% but 50% from day 0 to day 46 and day 91.	0th day to 46th and 91st day
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 Measures

Name	Time	Method
Dermatology Life Quality Index: Any subjects whose DLQI score increase 4 points and above.	Mode of action can be simulated

Trial Locations

Locations (1)

Siddha Regional Research Institute; 🇮🇳 Pondicherry, PONDICHERRY, India

Siddha Regional Research Institute

🇮🇳Pondicherry, PONDICHERRY, India

Dr R Rathinamala

Principal investigator

9445237368

drrmala@gmail.com