Efficacy of individualized homoeopathic medicines in the treatment of seborrheic dermatitis in adults: A double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Scalpdex: A quality of life instrument for scalp dermatitis
研究概览
简要总结
Seborrheic dermatitis is a common chronic, non-infectious, recurrent inflammatory disease of the skin that affects about 1-5% of the global population. In Indian adults with scalp dermatoses, 18.7% of cases were attributed to seborrheic dermatitis. It has been associated with overproduction of sebum and Malassezia yeast species and is manifested by greasy, scaly reddish-brown itchy patches in sebaceous, gland-rich regions of the scalp, face, and trunk affecting the quality of life of the patients. Homeopathy may have immense potential to offer in successful treatment of seborrheic dermatitis, however, the research evidence is limited. This 3-months, double-blind, randomized, placebo controlled trial is aimed at evaluating the efficacy of homeopathic medicines in the treatment of seborrheic dermatitis in 54 adults. The primary outcome measure is Scalpdex; the secondary outcomes are SEDASI, MYMOP-2 questionnaires, all measured at baseline, and every month, up to 3 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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from seborrheic dermatitis.
- •The diagnosis will be based upon recognizing folliculocentric lesions or erythematous plaques with yellow, greasy scales, and their typical distribution in seborrheic areas.
- •Age between 18 and 65 years.
- •Participants of either sex or transgender.
- •Patient’s ability to understand English/ Hindi/ Bengali.
- •Diagnosed cases of mild and moderate seborrheic dermatitis (ICD 11- EA81) (For scalp: EA81.1, For face: EA81.0) as per International Classification of Diseases for Mortality and Morbidity Statistics, 11th Revision, v2024-
- •Patients not taking any allopathic treatment or using topical agents for seborrheic dermatitis from past 2 weeks will be included in the study.
排除标准
- •Not providing with written informed consent of participation.
- •Patients suffering from severe form of seborrheic dermatitis or having super-added bacterial or candidal infection.
- •Patients who are too sick for consultation.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled systemic illness or life-threatening condition, affecting quality of life.
- •Pregnancy, puerperal women and lactating mothers
- •Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool).
- •Self-reported immune-compromised state, AIDS, hepatitis etc.
- •Undergoing homoeopathic treatment for any chronic disease within last 3 months.
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
Scalpdex: A quality of life instrument for scalp dermatitis
时间窗: Baseline, and every month, up to 3 months
次要结局
- SEborrheic Dermatitis Area and Severity Index (SEDASI)(Baseline, and every month, up to 3 months)
- Measure Yourself Medical Outcome Profile v.2 (MYMOP-2)(Baseline, and every month, up to 3 months)
研究者
Mukta Jain
D N De Homoeopathic Medical College and Hospital