An open clinical trial to study the efficacy of Ganthaga rasaayanam in patients having Psoriasis

Phase 3

Recruiting

• Conditions: KALANJAGAPADAI (PSORIASIS)

• Registration Number: CTRI/2017/08/009211
• Lead Sponsor: National Institute of Siddha

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-02
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

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

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Good outcome –Clearance of lesions and	40 Days
Reduction of PASI Score from 3,4 to 0,1.	40 Days
Moderate outcome –Partial clearance of lesions	40 Days
and Reduction of PASI Score from 3,4 to 2.	40 Days
Mild- Slight clearancce of lesions and reduction of PASI score from 4 to 3	40 Days
Nil- NO Clearance of lesions or No reduction PASI Score	40 Days

Trial Locations

Locations (1)

National Institute of Siddha; 🇮🇳 Kancheepuram, TAMIL NADU, India

National Institute of Siddha

🇮🇳Kancheepuram, TAMIL NADU, India

Dr R PRABAKARAN

Principal investigator

9715105196

prabakaranbsms@gmail.com