Efficacy of Unani Formulations, Irsale Alaq and Terbinafine, in Quba – A Comparative Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Comparison of achieved complete clearance among groups at the end of treatment
研究概览
简要总结
Patients fulfillingthe inclusion criteria will be enrolled after obtaining written informedconsent. They will be randomly allocated into 03 groups (by block randomizationmethod) viz; Group A, Group B, and Group C (n=37 in each group). Patientsin group A will be given Joshanda Aftimoon (oral) + Tila Ushaq (topical) in the dosageform as mentioned above. Whereas, patients in Group Bwill receive 07 sittings of Leech therapy with the interval of 05 days.Total 02 leeches will be applied per sitting. Moreover, group C patients will be advised to apply 1% Terbinafine cream over theaffected area and 1 inch surrounding that area in a thin layer twice dailyfor 30 days. Baseline clinical parameters suchas erythema, scaling, pruritus, papules will be assessed using 4 point scale bythe investigator. [Score 0=absent, 1=mild, 2=moderate, 3=severe]. Globalassessment score will be calculated on each follow-up visit by summation ofscores on all four parameters in a patient30,31,32,33.Patients will be instructed to come for theKOH mount after taking bath with unscented soap and water and without applyingany cream or ointment. They will also be advised to clean and dry the affected area before applying medication. TabletAtarax (Hydroxyzine) 10 mg single doses will be provided as rescue medicationif required. Follow-up will be done on 15thday for assessment of clinical cure, on 30th day for the clinical and mycologicalcure and after 45th day for potential relapse. Photographs of the lesion will be taken for evidence of improvement. Theinvestigations will be done before and after the completion of the trial. The pre and post-treatment objective findings (effects) will be assessedstatistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ïƒ˜Patients aged 18-60 years of either sex with a clinical diagnosis of Tinea corporis and/or Tinea cruris with ≤ 5% body surface area involvement Patients with Global assessment score of ≥ 5 with positive KOH mount Patients who will give consent and are able to do follow up.
排除标准
- •ïƒ˜Immuno-compromised patients Patients with extensive Dermatophytosis, other forms of tinea infections, superadded bacterial infection Patients with contact dermatitis, atopic dermatitis, psoriasis, other skin diseases Patients with a history of hypersensitivity to allylamine antifungals Patients who received topical antifungal within 1 week and systemic antifungals within 4 weeks prior to enrolment Patients with a known history or clinical evidence of bleeding disorders, severe systemic illness and uncontrolled diabetes mellitus Pregnant and lactating females.
结局指标
主要结局
Comparison of achieved complete clearance among groups at the end of treatment
时间窗: Baseline and after treatment
次要结局
- a.Comparison of achieved clinical cure among groups at the end of treatment(b.Comparison of achieved Mycological cure among groups at the end of treatment)