clinical evaluation of Parangichakkai chooranam (internal) and Karappan ennai(external)in the treatment of Balakarappan(Atopic dermatitis) in children.
- Conditions
- Atopic dermatitis, unspecified,
- Registration Number
- CTRI/2019/05/019123
- Lead Sponsor
- Ayothidoss pandithar hospital
- Brief Summary
IT Is a single non randomized open -label trial to determine the efficacy of PARANGICHAKKAI CHOORANAM (internal medicine) with KARAPPAN ENNAI (external medicine) in patients with BALAKARAPPAN(Atopic dermatitis). In the trial 30 Atopic dermatitis patients will be recruited and the trial drug parangichakkai chooranam , 5 to 6 years -1.3gm and 7 to 12 years -2gm, will be administrated orally after food twice a day and karappan ennai ( required quantity) will be applied for affected skin for a periods of 45 days.During the study period all the study related data will be recorded and documented in separate trial master file for each and every patients.During the trial period if the patient develop any adverse effect he/she will be immediately referred to the chairman, pharmaco- vigilance committee, NIS. If it will be mild event , the patient will be treated in OPD-NIS. If thr event will be reserve , the patient will be reffered to nearby Government Hospital and investigator will be take over the patient,until he/she will get recovery. the treatment will be provided with free of cost. 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 outcome of this trial will be published in Indian journal of Medicial research.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
children of both sexes in the age group of 5 to 12 years with symptoms of: 1.Erythema 2.Edema 3.Oozing 4.Itching 5.Crusting and Scaling 6.Lichenified plaque.
1.Scabies 2.photodermatitis 3.Fungal and parasitic skin infection 4.Psoriasis 5.Any other serious illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to evaluate the efficacy of Parangichakkai chooranam (Internal) and Karappan ennai(external)in the treatment of Balakarappan(Atopic dermatitis) using EASI Score 1 to 45 days
- Secondary Outcome Measures
Name Time Method to standardize the physico chemical properties of the trial drugs. To study the effect of trial drug in reducing the frequency of incidence ofBalakarappan
Trial Locations
- Locations (1)
Ayothidoss pandithar hospital
🇮🇳Kancheepuram, TAMIL NADU, India
Ayothidoss pandithar hospital🇮🇳Kancheepuram, TAMIL NADU, IndiadrskalaivaniPrincipal investigator9790146119drkalaivanibsms@gmail.com