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临床试验/CTRI/2022/04/042077
CTRI/2022/04/042077招募中2/3 期

Repertorial approach of treating tinea corporis using individualised homoeopathic medicines: Double-blind, randomized, placebo-controlled efficacy trial

D N De Homoeopathic Medical College Hospital1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2022年4月25日最近更新:

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)

研究者

申办方类型
Government medical college

研究点 (1)

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