A Clinical Study to Evaluate the Efficacy and Safety of Habb-i Hindi (O) and Habb-i Baras (L) in the Management of Baras (Vitiligo)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare relative efficacy of Unani drugs Habbi Hindi(o) and Habbi Baras(l) and Cmparator group PUVAsol and topical mometasone nonsegmental vitiligo by using VASI and VIDA Score To evaluate safety of Unani drugs Habbi Hindi(o) and Habbi Baras and comparator PUVAsol and topical mometasone Non segmental vitiligo
研究概览
简要总结
Baras (Vitiligo) is a social stigma as well as a cosmetic problem characterized by milky, white, hypo pigmented, sharply demarcated macules, which affects about 1% to 2 % of the world population, and is prevalent more than 8% in some regions of India. Females are comparatively more affected than males because of social stigma. It is mostly seen in the 2nd and 3rd decades of life. It has a familial incidence of 25 to 30 %. Vitiligo is a multifactorial, polygenic disorder, with a complex pathogenesis that is not yet well understood. Out of various propounded theories, some accepted suggestions are the autoimmune destruction of melanocytes, melanocytes adhesion, neurogenic damage, autotoxicity, etc. At present, available medical treatments for Baras are psoralens, longwave ultraviolet radiation (PUVA) and corticosteroids. Surgical therapies include mini grafting, melanocytes transplantation, and micropigmentation, but all these treatments have their own limitations with local and general side effects such as giddiness, epigastric discomfort, severe photo toxicity or blister reaction, perilesional hyperpigmentation, pruritus, trichosis, premature aging, and xerosis. In Unani Medicine, Baras is a well recognized disease entity and has been treated successfully since antiquity with various single and compound drugs. In recent years, various clinical trials have also been conducted to validate and confirm the claims of coded Unani drugs. Hence, the present study titled “A Clinical Study to Evaluate the Efficacy and Safety of HabbÂi Hindi (O) and HabbÂi Baras (L) in the management of Baras (Vitiligo)†has been designed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of any sex in the age group between 18 and 40 Years Patients with NonSegmental Vitiligo (NSV), disease chronicity from 6 months to 2 years Vitiligo involving more than 2% Body Surface Area (BSA) Patients with less than 5 New Lesions in the last month Patients with less than 15 lesions in the last 3 months Patients who have not received systemic treatment within 4 weeks prior to study entry Patients who have not received topical treatment within 2 weeks prior to study entry.
排除标准
- •Patients aged less than 18 years or more than 40 years Pregnant or Lactating Women Segmental Vitiligo (SV), liptip, or universal Vitiligo, or Vitiligo with leucotrichia History of Photosensitivity/Photoexaggerated Dermatoses and Connective Tissue Diseases Significant Pulmonary/Cardiovascular/Hepatorenal Dysfunction
- •Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies (Cutaneous or Internal) Patient not willing to attend treatment schedule regularly Patients not having a suitable facility for sun exposure.
结局指标
主要结局
To compare relative efficacy of Unani drugs Habbi Hindi(o) and Habbi Baras(l) and Cmparator group PUVAsol and topical mometasone nonsegmental vitiligo by using VASI and VIDA Score To evaluate safety of Unani drugs Habbi Hindi(o) and Habbi Baras and comparator PUVAsol and topical mometasone Non segmental vitiligo
时间窗: At baseline 4wk 8wk 12wk and 16wk
次要结局
- To compare the improvement in quality of life in patients with vitiligo assessed by PGA on VAS and IGA(At baseline 4wk 8wk 12wk and 16wk)