Clinical Study to assess the Efficacy and Safety of Haridradya Taila in Acne and Acne-induced Post-inflammatory Hyperpigmentation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary endpoint – Changes from baseline to the end of trial period in
研究概览
简要总结
Haridradya Taila is a classical preparation mentioned in kshudra
rogadhikar of Chakradatta.iii .
This taila is indicated in conditions of Acne as well as Hyper pigmentation of facial skin.
Present study aims to Evaluate and Document the Efficacy and Safety of local application of Haridradya Taila in treatment of Acne and post inflamatory Hyperpigmentation .
Primary Objective –
- To assess the efficacy of local application of Haridradya taila for its effect on mild to moderate Acne.
Secondary objective –
-
To assess the efficacy of local application of Haridradya Taila for its effect on Acne induced post inflammatory Hyper pigmentation.
-
To assess the safety and tolerability of local application of Haridradya Taila.
Assessment
For Efficacy Investigator’s Global Assessment (IGA) Scale for Acne Severity(Annex 1) Lesion counting (non inflammatory, inflammatory and total ) Acne induced Post inflammatory hyperpigmentation severity scale(Annex 2)For Safety and Tolerance Tolerance (0 – 3 point assessment scale)iv:Erythema, edema, scaling, dryness, burning, stinging & itchingPhotographs at baseline & 8 weeks: Findings will be compared andanalyzed for their significance to draw conclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex having mild to moderate facial Acne and mild to moderate acne induced PIH in clinical features. ï‚· Patients of age between
- •45 years. ï‚· Willing to take part in study and signing consent form.
排除标准
- •With Present History of Skin Disease e.g. Psoriasis, Dermatitis, Vitiligo etc.
- •related to face.
- •Person suffering from any infective or contagious skin disease
- •Under medication with antibiotics, antifungal and steroid during last one month.
- •Women on Oral contraceptives
- •Patients of known uncontrolled hormonal disease.
- •Any kind of diagnosed hereditary skin disorder.
- •Patient who had undergone any type of skin treatment like laser therapy in last 6 months.
结局指标
主要结局
Primary endpoint – Changes from baseline to the end of trial period in
时间窗: baseline, 4 weeks and 8 weeks
ï‚· Individual lesion count and overall lesion count in Acne
时间窗: baseline, 4 weeks and 8 weeks
 Overall grading of Acne in Investigator’s Global Assessment scale for Acne
时间窗: baseline, 4 weeks and 8 weeks
次要结局
- Secondary Endpoint( –Changes from baseline to the end of trial period in Acne induced Post inflammatory hyperpigmentation severity scale)