Evaluating feasibility of a double-blind, randomized, placebo-controlled trial ofindividualized homeopathic medicines in tinea corporis
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of patients in each group showing complete disappearance of the
研究概览
简要总结
The prevalence of superficial mycotic infection worldwide is 20-25% of which dermatophytes are the most common agents. Due to the lack of updated national or international guidelines on the management of tinea corporis, cruris, and pedis, treatment with systemic antifungals is often empirical. Although there is sufficient evidence to demonstrate the efficacy of topical antifungals in limited disease yet, there is scarce data on the frequency of relapse once topical monotherapy is discontinued. Though homeopathy is a popular choice among the patients, but peer-reviewed researches in tinea infection has remained seriously compromised. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 34 patients suffering from tinea corporis will be randomized to receive either individualized homoeopathic medicines (verum; n=17) or identical-looking placebo (control; n=17). We aim to address the feasibility issues of conducting a definitive efficacy trial of individualized homoeopathy and to investigate whether there are any differences in outcomes between these two groups over 2 months of intervention. Number of patients in each group showing complete disappearance of the skin lesion, intensity of pruritus measured by 0-10 numeric rating scales (NRS) and Skindex-29 scores will be used as the primary and secondary outcome measures. Feasibility issues will be checked and comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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 tinea corporis (2020 ICD-10-CM diagnosis code B35.4) since last 3 months
- •Age 18-65 years
- •Patients of either sex
- •Patient using topical agents for tinea lesions will be included after a washout period of two weeks
- •Patients who are literate and capable of filling the questionnaire and providing written informed consent.
排除标准
- •Cases with complication like lichenification and eczematisation
- •Similar looking skin conditions; e.g. seborrhic dermatitis, pityriasis rosea and psoriasis
- •Patients who are too sick for consultation
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
- •Pregnant and puerperial women and lactating mothers
- •Substance abuse and/or dependence
- •Self-reported immune-compromised state, and
- •Already undergoing homeopathic treatment for chronic disease within last 6 months.
结局指标
主要结局
Number of patients in each group showing complete disappearance of the
时间窗: At baseline and after 2 months
skin lesions
时间窗: At baseline and after 2 months
次要结局
- Skindex-29 scores(At baseline and after 2 months)
- Intensity of pruritus measured by 0-10 numeric rating scales(At baseline and after 2 months)
