Efficacy of Individualized Bacillinum 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
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 0 to 10 numeric rating scale (NRS), measuring intensity of itching
研究概览
简要总结
Dermatophyte infections are superficial fungal infections of the skin, hair, and nails. Commonly known as ringworm, these infections are caused by species of the genera Trichophyton, Microsporum, and Epidermophyton. The prevalence of superficial mycotic infection worldwide is 20-25%, of which dermatophytes are the most common agents. T. mentagrophytes surprisingly turned out to be the most common dermatophyte with a prevalence of up to 75.9 to 77.5%, followed
by T. rubrum but sometimes also by another Trichophyton. In India, there has been an increase in the prevalence of chronic and recurrent dermatophytosis over the last 4–5 years. This 3-month, double-blind, randomized (2:1), placebo-controlled, parallel-group, phase II/III efficacy trial will be the first attempt to explore the effects of individualized Bacillinum in centesimal potencies against placebo in itching intensity of tinea corporis using the Pruritus intensity score (numeric rating score—NRS). Intervention is planned as administering Bacillinum 30CH, 200CH, 1000CH, and 10000CH in individualized dosages, as decided appropriate by the physicians. Each dose will consist of 4 cane sugar globules no. 40, moistened with Bacillinum, to be taken orally on a clean tongue with an empty stomach. The medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Group differences will be examined in the end. Reports will be published in scientific journals.
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
- •Patients suffering from tinea corporis for 3 months or more, diagnosis confirmed through KOH mount test
- •Age between 18 and 65 years
- •Patients of either sex
- •Ability to understand English and/or Bengali
- •Providing written informed consent
- •Patients using topical agents for tinea lesions will be included after a washout period of two weeks
- •Matching symptomatology of Bacillinum.
排除标准
- •Cases with complications like lichenification and eczematisation
- •Similar-looking skin conditions, e.g., seborrheic dermatitis, pityriasis rosea, and psoriasis
- •Patients who are too sick for consultation, unable to read patient information sheets, unwilling to take part, or not giving consent to join the study
- •Vulnerable populations: unconscious, ambulatory, too sick for consultation, differently abled, terminally ill 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
- •Patients with the habit of tobacco chewing and/or smoking, alcoholism, and/or any other form(s) of substance abuse and/or dependence
- •Self-reported immunocompromised state
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
0 to 10 numeric rating scale (NRS), measuring intensity of itching
时间窗: day 0, 1st month, 2nd month, 3rd month
次要结局
- Skindex-29 questionnaire(day 0, 1st month, 2nd month, 3rd month)
- Dermatological Life Quality Index (DLQI) questionnaire(day 0, 1st month, 2nd month, 3rd month)
研究者
Shubhamoy Ghosh
D. N. De Homoeopathic Medical College and Hospital