A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study To Evaluate The Safety And Efficacy Of A Unani Formulation (Topical) Compared With Terbinafine (Topical) In The Management Of Quba (Tinea Corporis And Tinea Cruris)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Change in Total Signs & Symptoms Score (TSSS).
研究概览
简要总结
Tinea (ringworm) is a superficial fungal infection caused by dermatophytes (Trichophyton, Microsporum, Epidermophyton), commonly affecting keratinized tissues such as skin, hair, and nails. It is highly prevalent in tropical and subtropical countries like India, with significant social, emotional, and financial impact. Conventional antifungal drugs are effective but associated with side effects (hepatotoxicity, gastrointestinal upset, rashes, itching) often show resistance and limitations in pregnant or vulnerable population.
Unani medicine describes several formulations for Quba (dermatophytosis), including Roghan I Narjil, Marham e Quba Habb e Quba , and others containing drugs with pharmacological actions such as Musaffi Khun (blood purifier), Mu**hallil (resolvent), Jali(detergent), Mujaffif(desiccant), Dafa I kharish (antipruritic), and Daf I Taffun(antiseptic). Many of these formulations are in clinical use but not adequately evaluated scientifically.
Therefore, the present clinical trial is designed as a Randomized, Parallel-group, Open-label, Active-controlled study to evaluate the safety and efficacy of a Unani topical formulation compared with topical terbinafine to provide a potentially safer, cost-effective, and culturally acceptable alternative for managing Quba (tinea corporis and tinea cruris) .
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants of any gender in age group of 18-60 years
- •Participants of Quba (Tinea Corporis and Tinea Cruris) having circumscribed lesions with any of the following signs and symptoms on body, limbs and groin: a.
- •Presence of pruritus and burning b.
- •Presence of scales c.
- •Presence of central clearing d.
- •Erythematous papules
- •Participants with Positive KOH (10%) Smear Microscopy of Skin Scrapping from the active lesion for Dermatophytic Hyphae.
排除标准
- •Age below 18 years and above 60 years
- •Patients with other form of tinea infection like tinea capitis (head), tinea pedis (foot), tinea mannum (hands), tinea unguium (nails), tinea barbae (beard), tinea faciei (face), etc.
- •Patients with other concomitant diseases like psoriasis & eczema
- •Patients who have received any topical antifungal therapy within last 2 weeks or oral antifungal therapy in the previous 4 weeks
- •Participants not willing to give consent and to attend treatment schedule regularly
- •Patients with known active pulmonary/cardiovascular/ liver/ renal or neurological diseases
- •Known cases of Diabetes Mellitus or other immunocompromised disorders (HIV/ AIDS, etc.)/ Malignancies
- •Patients with long-term history of steroid, cytotoxic and immunosuppressive therapy
- •History of hypersensitivity to either Terbinafine or any test drug
- •Pregnant or lactating women, and women desiring pregnancy.
结局指标
主要结局
1. Change in Total Signs & Symptoms Score (TSSS).
时间窗: TSSS at baseline, 2nd, 4th and 6th week | KOH mount at baseline and 42nd day
2. Change in mycology finding (KOH mount).
时间窗: TSSS at baseline, 2nd, 4th and 6th week | KOH mount at baseline and 42nd day
次要结局
- 1.DLQI (Dermatology Life Quality Index)(2.Systemic Safety Assessment)
研究者
Dr Farhana Farheen Aqueel Ahmed
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad