A clinical research of siddha medicine in the management of Psoriasis (Kalanjagapadai)

Phase 3

Recruiting

• Conditions: kalanjagapadai (Psoriasis)

• Registration Number: CTRI/2017/06/008923
• Lead Sponsor: National Institute of Siddha

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-03
• Last Update Posted: 2017-06-24

Recruitment & Eligibility

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

Inclusion Criteria

1.Erythema 2.Thickness 3.Scaling 4.Itching; with or without itching 5.Auspitz sign + 6.Candle crease sign +.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GOOD OUTCOME-Clearence of lesions and reduction of PASI score from 3,4 to 1,2	48 days
MODERATE OUTCOME- Partial clearence of lesions and reduction of PASI score from 3,4 to 1,2	48 days
POOR/NIL-No clearence of lesions or no reduction of PASI Score	48 days

Trial Locations

Locations (1)

National institute of siddha; 🇮🇳 Kancheepuram, TAMIL NADU, India

National institute of siddha

🇮🇳Kancheepuram, TAMIL NADU, India

Dr S P Kopperundevi

Principal investigator

8056987496

dr.kopperundevipitchai@gmail.com