Application of Poly-herbal Powder for Treating Acne Vulgaris: A Randomized, Double-Blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in Total Lesions Count (TLC)
研究概览
简要总结
Acne is a common problem in adolescence to young adult. But there is no such remedy available for acne treatment which has no side effects. Different types of herbs powder has been using in patients with acne vulgaris in the traditional practice of Indian subcontinent as single form or compound. Scientific evidence have shown many herbs has no known side effects and effective on acne. These herbs have antibacterial, anti-inflammatory and anti-oxidant effects.
So, This study is intended to find out an inexpensive and safe alternative by using some common herbs such as Azadirachta indica, Curcuma longa, Lens culinaris Mentha arvensis and Trigonella foenum-graecum. The aim of the study is to evaluate the clinical efficacy of Poly herbal powder (PHP) for treating patients with acne vulgaris.
Total of 42 adults with acne vulgaris was recruited for this study. Study subjects was included both of male and female with age limit of 18 to 35 years.
Duration of study is 05 months with "day one advertisement" for screening followed by randomization for the treatment. The duration of active participation of each study subject was 3 consecutive weeks or 21days.
Difference of baseline and post intervention mean by Total lesion Count (TLC) compared with placebo and assesses the % of reduction of acne based on The Global Acne Grading System (GAGS) score.
Safety assessment was obtained from the incidence and type of adverse events during study period.
详细描述
Background:
Due to increasing interest from acne patients concerned about the side effects associated with conventional therapies, complementary and alternative medicine (CAM) has been suggested as a new therapeutic modality for acne vulgaris. Herbal medicine is one of these CAM treatments. Different types of herbs powder has been using in patients with acne vulgaris in the traditional practice of Indian subcontinent as single form or compound. As for example, Azadirachta indica, Curcuma longa, Ocimum sanctum, Lens culinaris, Trigonella foenum-graecum and Mentha arvensis etc. These herbs have antibacterial, anti-inflammatory and anti-oxidant effects. Therefore, this study was designed to evaluate the efficacy of poly-herbal powder (PHP) for treating acne vulgaris using some of these plants.
Objective:
To evaluate the clinical efficacy of PHP compared with that of placebo (PBO) in patients with acne vulgaris.
Sample Size:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women both aged between 18-35 years
- •Presenting minimum 5 acne lesions (whiteheads, blackheads, papules, pustules, nodules)
- •Study subject who will be agreed with Online informed consent.
排除标准
- •Have infected acne lesions
- •If study subject suffers from any serious medical conditions such as uncontrolled hypertension, diabetes mellitus, past or current malignancy, liver or kidney dysfunction, active pulmonary tuberculosis other severe dermatitis, or any infectious or systemic diseases.
- •Use of a topical medication containing steroids for the treatment of skin disease more than once per month.
- •Hypersensitive skin.
- •Erythema, or telangiectasia at the test site.
- •Use of the same or similar cosmetics (or pharmaceutical) on the test site within three months of screening.
- •Having undergone a skin peeling or having wrinkles removed within six months.
- •Any other reasons of unsuitability for the clinical trial at the discretion of the study.
结局指标
主要结局
Change in Total Lesions Count (TLC)
时间窗: 03 weeks
Total Lesions Count (TLC) = Comedones + Papules + Pastules, before and after intervention will be presented as percentage as well as mean and standard deviation.
次要结局
- Change in The Global Acne Grading System score(03 weeks)
- Change in non-inflammatory and inflammatory lesions count(03 weeks)
研究者
Dr. Md. Shahab Uddin
Principal Investigator
Hamdard University