A clinical Research of siddha medicine in the management of kaalaanjagappadai(psoriasis)

Phase 3

Recruiting

• Conditions: Kaalaanjagappadai (Psoriasis)

• Registration Number: CTRI/2014/12/005339
• Lead Sponsor: NATIONAL INSTITUTE OF SIDDHA

Brief Summary

Itis a single, non-randomized, open-label trial to determine the efficacyand safety of GANTHI MEZHUGU (Prepared from herbo mineral constitutents)in patients with KAALAANJAGAPPADAI (PSORIASIS). In this trial40 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 thestudy related data will be recorded and documented in a page separatetrial master file for each patients.During the trial period if anyAE/SAE/SUSAR will be noticed and referred to pharmacovigilancedept.in NIS and further management will alsobe given in NIS OPD/IPD.The entire trial will be monitored by theresearch monitoring committee OF NIS. During this trial all the safety andefficacy parameters will be recorded in the CRF. After completion of thetrial all the study related data will be analysed statistically .The outcome of this trial will be published in Indian Journal of Medical Research

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-31
• Last Update Posted: 2015-01-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• •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.

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Good outcome –Clearance of lesions and Reduction of PASI Score from 3,4 to 0,1.	PRE STUDY SCREENING AND AFTER | TREATMENT
Moderate outcome –Partial clearance of lesions and Reduction of PASI Score from 3,4 to 1,2.	PRE STUDY SCREENING AND AFTER | TREATMENT
Poor/Nil- NO Clearance of lesions or No reduction PASI Score	PRE STUDY SCREENING AND AFTER | TREATMENT

Trial Locations

Locations (1)

NATIONAL INSTITUTE OF SIDDHA; 🇮🇳 Kancheepuram, TAMIL NADU, India

NATIONAL INSTITUTE OF SIDDHA

🇮🇳Kancheepuram, TAMIL NADU, India

DR R SELVAKUMAR

Principal investigator

7402480757

dr.selvakumar7@gmail.com