Clinical Evaluation of Nimbadi Churna, Khadirarishta and Arjuna lepa in the management of Yuvan Pidika (Acne)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Primary outcome measure
研究概览
简要总结
The present study aims toevaluate the efficacy of Nimbadichurna, Arjuna Lepa, and Khadirarishtain treating mild to moderate acne. It is an open-label single-arm prospective interventional study involving 40 participants in each center with a total of 120 participants. The total study duration is 24 months wherein acne patientsof either sex with age between 18 and 45 years are included in the Study. Intervention is for 12 weeks and the outcome is the improvement in the assessment parameters such as Global Acne Grading System, Investigators’ Global Assessment (IGA) scale, Assessment of Ayurvedic parameters of Yuvan Pidika, Dermatology life Quality Index (DLQI) Questionnaire, The Cardiff Acne Disability Index, and Patient Satisfaction (PS) Scoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Primary outcome measure
时间窗: at baseline, 15th day, 30th day, 45th day, 60th day, 75th day, 90th day and 105th day
Change in Global Acne Grading System score
时间窗: at baseline, 15th day, 30th day, 45th day, 60th day, 75th day, 90th day and 105th day
Change in Investigators Global Assessment IGA scale score
时间窗: at baseline, 15th day, 30th day, 45th day, 60th day, 75th day, 90th day and 105th day
次要结局
- Change in the Ayurvedic parameters of Yuvan Pidika(Change in Dermatology Life Quality Index (DLQI) Questionnaire)