Comparison of clinical efficacy and safety of Unani therapy in the form of systemic UNIM 004 & topical UNIM 005 with sunlight and conventional allopathic therapy in form of PUVA sol and topical mometasone cream in the treatment of clinically stable vitiligo
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 1.To compare relative efficacy of a combination of oral UNIM 004 and lotion UNIM-005 (Unani formulation) and oral PUVAsol and topical mometasone (standard allopathic therapy) in stable vitiligo.
研究概览
简要总结
Vitiligo is a common disorder that causes patchy depigmentation and is often associated with immense psychosocial impact. Compounding this is the challenge of getting cosmetically acceptable pigmentation since the presently available treatment options are not only suboptimally effective but also do not give a good color match. Conventionally it is believed that the traditional systems of medicine have much to offer in treatment of vitiligo. Though there are a few reports of efficacy of Unani medicines (mostly in the form of CCRUM generated monograms) in the treatment of vitiligo (Baras), there is dearth of systemic evaluation of safety and efficacy of these drugs especially vis a vis allopathic treatment options available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor 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
- •Subjects of either sex, aged 18-65 yrs.
- •Vitiligo involving >2% body surface area.
- •Subject with <5 new lesions in last 1 months.
- •Subject with < 15 lesions in previous 3 months.
- •No systemic treatment in the previous 4 weeks.
- •No topical treatment in previous 2 weeks.
排除标准
- •Age < 18 years or > 65 years.
- •Pregnant or lactating women.
- •Segmental vitiligo, lip-tip, or universal vitiligo.
- •Significant cardiac, pulmonary & hepato- renal dysfunction.
- •History of photosensitivity/ photo exaggerated dermatoses and connective tissue diseases.
- •Patients with immunocompromised states (including HIV/AIDS) or malignancies (cutaneous or internal).
- •Patient unsure about attending treatment schedule regularly.
- •Patients who do not have a suitable facility for sun exposure.
结局指标
主要结局
1.To compare relative efficacy of a combination of oral UNIM 004 and lotion UNIM-005 (Unani formulation) and oral PUVAsol and topical mometasone (standard allopathic therapy) in stable vitiligo.
时间窗: at baseline, 4wk, 12wk, 20wk, 28wk, and 36wk
3.To compare the improvement in quality of life in patients with vitiligo treated with the Unani combination vis-a vis the Allopathic combination.
时间窗: at baseline, 4wk, 12wk, 20wk, 28wk, and 36wk
2.To evaluate the safety of combination of oral UNIM-004 and lotion UNIM-005 (Unani formulation) in treatment of vitiligo.
时间窗: at baseline, 4wk, 12wk, 20wk, 28wk, and 36wk
次要结局
- 1.To compare the rapidity of response in vitiligo using Unani treatment vs Allopathic treatment.(at baseline, 4wk, 12wk, 20wk, 28wk, and 36wk)