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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/12/005339
• Date of registration: 31-12-2014
• Prospective Registration: Yes
• Primary sponsor: NATIONAL INSTITUTE OF SIDDHA
• Public title: A clinical Research of siddha medicine in the management of kaalaanjagappadai(psoriasis)
• Scientific title: SAFETY AND COMPARATIVE OPEN CLINICAL STUDY OF â??GANTHI MEZHUGUâ?? (INTERNAL) AND â??KUTTA NOIKALUKKU MEL POOTCHU ENNAIâ?? (EXTERNAL) IN THE TREATMENT OF â??KAALAANJAGAPPADAIâ?? (PSORIASIS) WITH AND WITHOUT YOGAM THERAPY
• Date of first enrolment: 31-12-2014
• Target sample size: 40
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9522
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: DR N J MUTHUKUMAR
• Affiliation: NATIONAL INSTITUTE OF SIDDHA

• Name: DR R SELVAKUMAR
• Affiliation: NATIONAL INSTITUTE OF SIDDHA

Key inclusion & exclusion criteria

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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Kaalaanjagappadai (Psoriasis)

Intervention(s)

Intervention1: Ganthi Mezhugu (Internal) and Kutta Noikalukku Mel Pootchu Ennai (External): 260mg of Ganthi Mezhugu administered orally twice a day for a period of 48 days.Kutta Noikalukku Mel Pootchu Ennai(External)will be issued 50 ml to apply the affected areas of skin.
Control Intervention1: nil: nil

Primary Outcome(s)

Good outcome â??Clearance of lesions and Reduction of PASI Score from 3,4 to 0,1.

Moderate outcome â??Partial clearance of lesions and Reduction of PASI Score from 3,4 to 1,2.

Poor/Nil- NO Clearance of lesions or No reduction PASI Score

Timepoint: PRE STUDY SCREENING AND AFTER

TREATMENT

Secondary Outcome(s)

NILTimepoint: NIL

Secondary ID(s)

NIL

Source(s) of Monetary Support

AYOTHIDOSS PANDITHAR HOSPITAL NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI

Ethics review

Status: Approved
Approval date: 24/12/2013
Contact:

INSTITUTIONAL ETHICS COMMITTEE