Repertorial approach of treating tinea corporis using individualised homoeopathic medicines: Double-blind, randomized, placebo-controlled efficacy trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- 5-D pruritus scale
研究概览
简要总结
The prevalence ofsuperficial mycotic infection worldwide is 20-25% of which dermatophytes arethe most common agents. Homeopathypeer-reviewed research in tinea infection has remained seriously compromised. A double-blind, randomized, placebo-controlledtrial on 128 participants is attempted at D. N. De Homoeopathic Medical Collegeand Hospital to identify the differences between individualized homeopathicmedicines and identical-looking placebos in treatment of tinea corporisafter 3 months of intervention. Participants will be randomized into eitherverum (n=64) or placebos (n=64) in the mutual context of concomitant care,e.g., application of olive/coconut oil, maintaining local hygiene, keeping thearea dry, etc. Primary outcome measure is 5-D pruritus scale and secondaryoutcome measures are Skindex-29 questionnaire and dermatological life qualityindex (DLQI) questionnaire; all to be measured at baseline, and every month, upto 3 months. Comparative analysis will be carried out to detect groupdifferences. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 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 (B35.4) for 3 months or more, diagnosis confirmed through KOH mount test
- •Age between 18 and 65 years
- •Patients of either sex
- •Literate patients; ability to read English and/or Bengali
- •Providing written informed consent
- •Patient using topical agents for tinea lesions will be included after a washout period of two weeks.
排除标准
- •Cases with complication like lichenification and eczematisation
- •Similar looking skin conditions; e.g., seborrheic dermatitis, pityriasis rosea and psoriasis
- •Vulnerable population – Unconscious, differently abled, terminally or critically ill patients, mentally incompetent people
- •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 puerperal women, lactating mothers
- •Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence
- •Self-reported immune-compromised state
- •Already undergoing homoeopathic treatment for chronic disease within last 6 months.
结局指标
主要结局
5-D pruritus scale
时间窗: Baseline, every month, up to 3 months
次要结局
- Skindex-29 questionnaire total and subscale scores(Baseline, every month, up to 3 months)
- Dermatological life quality index (DLQI) total and subscale scores(Baseline, every month, up to 3 months)