Therapeutic Evaluation of Unani polyherbal formulation in the treatment of Quba (tinea corporis)-A randomized open-labelled standard control clinical trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Change in Investigator’s global assessment(IGA)of clinical responses (see annexure-II for details)
研究概览
简要总结
Quba (dermatophytosis/tinea) is a infection of keratinized tossues (epidermis,hair,nails) caused by dermatophytes, primarily Trichophyton rubrum. It is classified based on the infection site, including tinea capitis,tinea corporis,tinea cruris ,tinea pedis and tinea unguium. The prevalence depend ons on host and environmental factors, affecting 20-25% of the global population, with India reporting a 36.6-78.4% prevalence. Tinea corporis is the most common form , followed by tinea cruris.
Treatment includes topical (azoles like ketoconazole, lulliconazole,clotrimazole) and oral antifungals (turbinafine,fluconazole,itraconazole,griseofulvin), but concerns over drug resistance, recurrence and toxicity (hepatotoxicity, nephrotoxicity ,myelotoxicity) persist.
in Unani medicine, Quba (Daad) is attributed to Mirrasawda (bilious melancholy) or Rutubat-i-Ghaliz and Balgham-i-Shor (saline phlegm) in the blood, redirected peripherally by Quwwat- i- Tabiyya, leading to pruritic skin.Treatments involve Tehlil-e-warm,Taltif -e-madda,Taskin, and Tartib, using systemic and topical agents like roghan-e-gandum, marham-henna, marhan-e-quba, and paste of mazu mixed with cow urine, as well as Joshand-e-aftimoon for systemic therapy.
Classical Unani texts highlight Anjirdashti, Tukhm e panwar, Babchi, and Narkchoor for effective Quba treatment, but scientific validation is lacking. The current study, "Therapeutic Evaluation of Unani Polyherbal Formulation in the Treatment of Quba (Tinea Corporis)", is a randomized, open-label, standard-controlled clinical trial designed to evaluate the efficacy and safety of this formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient diagnosed with tinea corporis clinically, as well as by KOH mount test without nail and scalp involvement.
- •BSA less then or equal to 20 percent.
- •Patient who are willing and able to provide informed consent.
排除标准
- •Presence of complications such as secondary bacterial infection of the lesions.
- •Patients already on topical and/or systemic antifungal treatment (1 week of topical therapy and/or 4 weeks of systemic antifungal therapy before baseline visit)
- •Patients with diabetes mellitus.
- •Immunosuppressant patients like AIDS/HIV infection.
- •Pregnant and lactating women.
- •Noncompliance with the trial protocol.
结局指标
主要结局
1. Change in Investigator’s global assessment(IGA)of clinical responses (see annexure-II for details)
时间窗: 14th, 28th and 42nd day.
2. Mycological cure: Clinically suspected cases of tinea corporis will be confirmed by skin scraping and KOH preparation, by visualizing presence or absence of long, narrow, septate and branching hyphae under microscope at baseline and at the conclusion of trial.
时间窗: 14th, 28th and 42nd day.
次要结局
- 1. Change in TCS (Total clinical score) (see Annexure-III for details)(2. Changes in Dermatology Life Quality Index (see Annexure-IV for details))
研究者
Dr Syeda Nashim Banu
Luqman Unani Medical College