A double-blind, randomized, placebo-controlled trial using individualized homoeopathic medicines in acne vulgaris in adolescents and young adults
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Global Acne Grading Scale (GAGS)
研究概览
简要总结
Acne vulgaris ia a chronic disorder of the pilosebaceous apparatus associated with an increase in sebum secretion. It is characterized by open comedones (blackheads), closed comedones (whiteheads), and pustular nodules.Homoeopathy is a frequently used therapy to treat acne vulgaris ;however, the research evidence is limited. This 4 months , double-blind, randomized, placebo-controlled trial is aimed at evaluating the efficacy of homoeopathic medicines in the treatment of acne vulgaris in 107 adolescents and young adults. The primary outcome is GAGS ; the secondary outcomes are Acne-QoL questionnaire ,and MYMOP-2 questionnaires , all measured at baseline , and every month ,up to 4 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 39.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 10-39 years.
- •Patients of either sex and transgender.
- •Patients with acne vulgaris (ICD -11 code ED80.Z) with GAGS score (moderate, 19-30) form from 3 months or more.
- •History of typical variable skin symptoms: presence of comedones , papules ,pustules or nodules.
- •Patient having oily texture of the skin with prominent follicular openings.
- •Typical distribution of acne at face (nose, cheeks, forehead, etc.) trunk ,back and chest.
- •Patients able to understand English/Hindi/Bengali.
排除标准
- •Patient having mild GAGS 1 to 19, severe GAGS 31 to 38, to very severe GAGS more than 39, forms of acne .
- •Patient using oil based cosmetics for long period.
- •Patient who are too sick for consultation.
- •Patient denying consent or assent voluntarily.
- •Vulnerable population including unconscious ,non ambulatory, terminally or critically ill patients, mentally incompetent people.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life threatening illness affecting the quality of life or any organ failure.
- •Tobacco chewing or smoking, alcoholism or any other form of substance abuse or dependence.
- •Pregnant and puerperal women, lactating mothers.
- •Self reported immune compromised state.
- •Already undergoing homoeopathic treatment for chronic diseases other than acne within the last 1 month.
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
Global Acne Grading Scale (GAGS)
时间窗: Baseline, and every month, up to 4 months
次要结局
- Acne-Specific Quality of Life Questionnaire (Acne-QoL)(Baseline , and every month, up to 4 months)
- Measure Yourself Medical Outcome Profile v.2 (MYMOP-2)(Baseline , and every month, up to 4 months)
研究者
Beena Das
D N De Homoeopathic Medical College And Hospital