Pre clinical and Clinical evaluation of karappan nei (internal and external medicine) in the treatment of Eczema in children

Phase 3

Not yet recruiting

• Conditions: Bala karappan

• Registration Number: CTRI/2017/05/008722
• Lead Sponsor: Ayothidoss pandithar hospital

Brief Summary

It is the single non-randomized,open label trial to determine the efficacy of Karppan nei (internal and external medicine) prepared from herbal constitutents in the patients with Balakarappan (Eczema). In this trial 30 patients will be recruited and the trial drug will be administered 5-10 ml Twice a day with honey for a period of 48 days. During the trial period if any AE/SAE/SUSAR will be noticed and refered to pharmacovigilance 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 India Journal of Medical research.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-08
• Last Update Posted: 2017-05-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Children with symptoms of pain in lower extremities, Itching, Papules, Vesicles, Pustules, Ulcer, Oozing, Hyper pigmentation, Sleep disturbances 2.Patients willing to Blood investigation when required 3.
• Patient willing to be admitted in the hospital or willing to attend OPD once in 7 days for 48 days.

Exclusion Criteria

• 1.Scabies 2.
• Photo dermatitis 3.
• Jaundice 4.
• patients with any other serious illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is mainly assessed by reduction of Clinical symptoms by using SCORAD scale	48 datys

Secondary Outcome Measures

Name	Time	Method
It is mainly assessed by therapeutic efficacy of the trial drugs	48 days

Trial Locations

Locations (1)

Ayothidoss pandithar hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Ayothidoss pandithar hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr Bakkiyadevi M

Principal investigator

9994627411

bakkiyadevim@gmail.com