To study the effects of a Unani formulation in patients with Acne.
Phase 2
- Conditions
- Health Condition 1: L700- Acne vulgaris
- Registration Number
- CTRI/2023/03/050493
- Lead Sponsor
- Central Council for Research in Unani Medicine New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Patients of age between 12-40 years.
2) Patients with mild to moderate forms of acne.
3) Irrespective of gender.
4) Patients with itching, erythema, comedones,
papules and pustules.
5) Patients who are willing to give consent and
are able to follow up.
Exclusion Criteria
1) Patients below 12 years and above 40 years of
age.
2) Patients with severe forms of acne.
3) Diagnosed patients of PCOS.
4) Pregnant and lactating women.
5) Patients on corticosteroid therapy and on
OCPâ??s.
6) Patients suffering from systemic illnesses like
Cardiovascular disease, chronic kidney disease
and chronic liver disease, thyroid disease or
malignancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Change from baseline to day 41st in the inflammatory (Papules and pustules) lesions and non-inflammatory (open and closed comedones) lesions (GAGS- Global Acne Grading System). <br/ ><br>2) Change from baseline to day 41st in Investigatorâ??s Global Assessment of Acne (IGA). <br/ ><br>3) Change from baseline to day 41st day in the inflammatory (papules and pustules) lesions <br/ ><br> based on photographs of lesions. <br/ ><br>4) Change from baseline to day 41st day in the quality of life of subjects based on the Dermatology Life Quality Index (DLQI). <br/ ><br> <br/ ><br>Timepoint: 40 days.
- Secondary Outcome Measures
Name Time Method <br/ ><br>1)Effect on itching based on Visual Analogue Scale (VAS). <br/ ><br>2) Effect on redness based on Clinical Erythema Assessment (CEA). <br/ ><br>3) Effect on eruptions based on Simple Grading System by Indian Authors.Timepoint: 40 Days.