Health Condition 1: L309- Dermatitis, unspecified
Conditions
Interventions
Intervention1: Arq-i-Shahtara: Topical Unani Formulation
Intervention2: 1. Arq-i-Shahtara (Oral),
2. Topical Unani Formulation (Local): 1. Arq-i-Shahtara: Dosage Form - Arq(Liquid), Dose - 125ml BD, M
Sponsors
National Research Institute of Unani Medicine for Skin Disorders
Eligibility
Inclusion criteria
Inclusion criteria: The participants will be included in the study on the basis of the following criteria: 1. Participants of any gender between eighteen to sixty-five years of age. 2. Participants having the following any signs and symptoms of disease like Itching, Erythema, Visible flexural eczema, Excoriation, Hyperpigmentation, Burning sensation, Lichenification, Crusting, Dry skin. 3. Participants who are able and willing to comply with the protocol and to sign ICF. 4. Chronicity of more than six months and less than two years.
Exclusion criteria
Exclusion criteria: The following patients will be excluded: 1. Participants aged Less than eighteen years and more than sixty-five years. 2. Known cases of significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction, Malignancy, HIV infection, AIDS, etc. 3. Any other clinical condition that in the opinion of the investigator would compromise the patient safety or successful participation in the trial. 4. Pregnancy and Lactation. 5. Known allergy, sensitivity or intolerance to the study drug or any of its ingredients. 6. Participants with active alcohol intake and/or drug abuse. 7. Participants not willing to sign the ICF and to attend treatment schedule regularly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Efficacy: Clinical assessment will be done at baseline visit and at each follow-up visit 2nd, 4th and 6th weeks and the assessment of response to treatment will be made on the basis of the change in EASI Score from baseline to the end of treatment, i.e., 6 weeks of therapy. For the efficacy of the test drug, 25% change in appearance and symptomatic relief will be considered significant.Timepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Photographic Assessment: Digital photography of all lesions will be done using conditions (fixed room, fixed lighting and fixed camera settings) at baseline and 6th week.Timepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactDR WASI AHMAD
National Research Institute of Unani Medicine for Skin Disorders
Outcome results
None listed