Efficacy of individualized homoeopathic medicines in the treatment of tinea corporis 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
- 108
- 试验地点
- 1
- 主要终点
- Skindex-29 questionnaire
研究概览
简要总结
Superficial mycotic infections affect approximately 20–25% of the global population, with dermatophytes being the most common causative agents. Tinea is characterized by slow-growing lesions that frequently have some central clearance (ring-like). In certain people, the fungus causes virtually minimal inflammation; in these patients, the infection manifests as a marginated area of rough, scaling skin. Treatment typically involves topical antifungals for mild cases, while more extensive infections often require systemic therapy. In recent years, chronic dermatophyte infections have become increasingly common and challenging to treat. However, the absence of updated national or international guidelines for managing tinea corporis, tinea cruris, and tinea pedis has led to largely empirical systemic antifungal treatments [3]. Homeopathy may have immense potential to offer in the successful treatment of tinea corporis, but concrete data is not available for this claim. Under such circumstances, we intend to undertake this research project to evaluate the Efficacy of individualized homoeopathic medicines in the treatment of tinea corporis in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 108 adults who are suffering from tinea corporis at the outpatient department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by the Skindex-29 questionnaire [Primary outcomes], 5-D pruritus scale, and MYMOP-2 (Measure Yourself Medical Outcome Profile) [Secondary outcomes] every month up to 2 months. Comparative analysis will be carried out to detect group differences.
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
- •1.Patients suffering from tinea corporis (1F21.1 ref.
- •ICD11) for 3 months or more, diagnosis confirmed through KOH mount test.
- •2.Age between 18 and 65 years 3.Patients of either sex or transgender.
- •4.Patients previously treated with topical antifungal agents will be eligible for enrolment following a minimum washout period of seven days.
排除标准
- •1.Patients with complications such as lichenification or eczematization.
- •2.Skin conditions that mimic tinea, such as seborrheic dermatitis, pityriasis rosea, and psoriasis.
- •3.Individuals who are too unwell for consultation, unable to comprehend the patient information sheet, or unwilling to participate.
- •4.Diagnosed cases of other systemic disease i.e., uncontrolled diabetes or life-threatening illness affecting quality of life, or any organ failure.
- •5.Vulnerable groups include unconscious, non-ambulatory, critically or terminally ill patients, differently abled individuals, and those with mental incompetence.
- •6.Pregnant, postpartum, or lactating women.
- •7.Individuals with a history of tobacco use (chewing or smoking), alcohol dependency, or any form of substance abuse (TAPS tool) [36].
- •8.Self-reported immunocompromised individuals, AIDS, hepatitis, etc.
- •9.Patients who have received homeopathic treatment for a chronic illness within the last six months.
- •10.Simultaneous participation in any other clinical activity.
结局指标
主要结局
Skindex-29 questionnaire
时间窗: At baseline, monthly, up to 2 months
次要结局
- 5- D Pruritus Scale(At baseline, monthly, up to 2 months)
- Measure Yourself Medical Outcome Profile version 2.0 (MYMOP-2)(At baseline, monthly, up to 2 months)
研究者
Nafisa Khatun
D N De Homoeopathic Medical College and Hospital
