Efficacy of certain Ayurvedic formulations in the management of Acne
- Conditions
- Health Condition 1: L709- Acne, unspecified
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients of either sex with age between 18 and 45 year
2.Patients with acne inflammatory lesion (Papules and Pustules) count less than twenty, non-inflammatory lesion (open and closed comedones) count less than fifty and nodules less than four
3.Willing to participate in the study
1.Patients with Secondary acne and severe acne viz. acne fulminans, acne conglobate, acne excoriate.
2.Patient with the presence of cysts.
3.Patient taking any topical or systemic treatment for acne for last 2 weeks.
4.Patients with cosmetic induced acne.
5.Patients pregnant or lactating or in menopause or taking oral contraceptives.
6.Patients with polycystic ovarian syndrome or undergoing treatment for infertility.
7.Dermal sensitivity to light, generalized skin lesions, eczema, psoriasis, herpes simplex, herpes zoster, scabies, urticaria, and immunological medicated skin diseases like pempigus vulgaris, dermatitis, lupus erythematous, psoriatic arthropathy etc.
8.Immuno-compromised states and patients with systemic infections orknown cases of AIDS, HIV, STD etc.
9.Patients with severe/history of cardiac, hepatic, cerebrovascular disease, pulmonary dysfunction, malignancy, chronic uncontrolled systemic diseases or renal disorder ( S. creatinine >1.2 mg/dl) etc or poorly controlled hypertension (Blood pressure more than 160/100mm of Hg), uncontrolled Diabetes Mellitus (HbA1c >= 8), or any other serious medical illness.
10.Patients on medication with corticosteroids or any other drugs that may have an influence on the outcome of the study.
11.History of hypersensitivity to the trial drug or any of its ingredients.
12.Patients with facial beard or mustache that could interfere with the study assessments.
13.Patients who have completed participation in any other clinical trial during the past three months.
14.Any other condition which the Investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measure <br/ ><br>Change in Global Acne Grading System score <br/ ><br>Change in Investigators Global Assessment IGA scale score <br/ ><br>Timepoint: at baseline, 15th day, 30th day, 45th day, 60th day, 75th day, 90th day and 105th day
- Secondary Outcome Measures
Name Time Method Change in the Ayurvedic parameters of Yuvan Pidika <br/ ><br>Change in Dermatology Life Quality Index (DLQI) Questionnaire <br/ ><br>Change in The Cardiff Acne Disability Index <br/ ><br>Change in Patient Satisfaction (PS) Scoring <br/ ><br>Timepoint: at baseline, 15th day, 30th day, 45th day, 60th day, 75th day, 90th day and 105th day