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临床试验/CTRI/2021/02/031442
CTRI/2021/02/031442招募中2/3 期

Evaluating feasibility of a double-blind, randomized, placebo-controlled trial ofindividualized homeopathic medicines in tinea corporis

D N De Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年2月24日最近更新:

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)

研究者

发起方
D N De Homoeopathic Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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