CTRI/2023/03/050218Not yet recruitingPhase 2
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Efficacy and Safety of a topical Unani Formulation in the Management of NÄr FÄrsÄ« (Eczema)
National Research Institute of Unani Medicine For Skin Disorders1 site in 1 country60 target enrollmentStarted: May 3, 2023Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 25% change in appearance and symptomatic relief will be considered significant
Study Overview
Brief Summary
*NÄr FÄrsÄ« (*Eczema) is a chronic skin disease, with high incidence, and recurrence. Moreover, topical steroids used in the management of eczema impair barrier functions and exhibit the adverse effects, such as skin atrophy, pituitary adrenal axis suppression, and masked infections, and steroid withdrawal can lead to sudden and severe rebound aggression, thinning of skin with striae, bruising, delayed wound healing, depigmentation, etc. Thus, there is no promising cure for eczema; hence the present clinical study has been designed to evaluate the Safety and Efficacy of a topical Unani Formulation Habb-e- Akuta in the management of eczema.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Participants having the following signs and symptoms of disease: Itching, History of Asthma / hay fever in 1st degree relatives, Visible flexural eczema, Excoriation, Burning sensation, Lichenification, Crusting, Dry skin.
- •Participants who are able and willing to comply with the protocol and to sign ICF
- •Chronicity of more than 6 months and less than 2 years.
Exclusion Criteria
- •1.Participants aged Less than 18 years and more than 65 years
- •Known cases of significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction, Malignancy, HIV infection, AIDS, etc.
- •Any other clinical condition that in the opinion of the investigator would compromise the patient’s safety or successful participation in the trial.
- •Pregnancy and Lactation
- •Known allergy, sensitivity or intolerance to the study drug or any of its ingredients
- •Participants with active alcohol intake and/or drug abuse
- •Participants not willing to sign the ICF and to attend treatment schedule regularly.
Outcomes
Primary Outcomes
25% change in appearance and symptomatic relief will be considered significant
Time Frame: 42 days
Secondary Outcomes
- Digital photography of all lesions will be done using conditions (fixed room, fixed lighting and fixed camera settings )(42 days)
Investigators
Study Sites (1)
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