A Randomized, Open-Label, Active Controlled, Parallel-Group Clinical Study to Compare the Safety and Efficacy of Itrifal Shahtra and Marham Hina with PUVAsol and Petroleum Jelly in the Management of Taqashshur al-Jild (Psoriasis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The response to treatment will be assessed using the following parameters:
研究概览
简要总结
Taqashshur al-Jild (Psoriasis) is a chronic inflammatory, hyperproliferativeskin disease, characterized by well defined, erythematous scaly plaque,particularly affecting extensor surfaces, scalps and nails usually follows arelapsing and remitting course.It is twice morecommon in male compared to female population.
In Unani classicalliterature, Taqashshur al-Jild isdefined as a type of skin disease characterized by roughening and hardening ofaffected part of the skin accompanied by sloughing of fish-like scales anditching.
The conventionaltherapies used for treatment of Taqashshur al-Jild(Psoriasis) have a good effect but they have their own limitations and some reported sideeffects like nausea, hyperpigmentation, pruritus, phototoxicity with seriouscomplications such as skin carcinoma, hepatotoxicity and also worsening of disease.
In theUnani System of Medicine, the main therapy of psoriasis includes drugs thatpurify the blood and normalize skin metabolism by strengthening its faculties.The primary goal of treatment in psoriasis is to relieve the discomfort bycontrolling the signs and symptoms. Since psoriasis is usually dry and itchy,most treatments involve the application of lotions, creams or ointment, oils tokeep the skin as moist as possible.
Unani formulations, ItrÄ«fal ShÄhtra possess Muá¹£affÄ«-iDam (blood purifier) and Munzij wa Mush’il-i Sawda’ (concoctive andpurgative of melancholic humor) and Murattib-i ‘UmÅ«mi (emollient) actions andMarham Hina possess emollient, DÄfi‘-i ‘UfÅ«nat (disinfectant), Musakkin-i MuqÄmi (local Analgesic), DÄfi‘-iSozish (Anti pruritic), DÄfi‘-I Waram (Anti-inflammatory)action respectively, but their efficacyand safety has yet to be proved on scientific parameters10,11.
Keepingthe above facts in view, it has been planned to conduct “A Randomized, Open-Label, Active Controlled, Parallel-GroupClinical Study to Compare the Safety and Efficacy of Itrifal Shahtra andMarham Hina with PUVAsol and Petroleum Jelly in the Management of Taqashshur al-Jild (Psoriasis)â€.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1-Patients of any sex in the age group between 18 and 65 years 2-Patients with clinically diagnosed Taqashshur al-Jild (Psoriasis) of plaque-type 3-Psoriasis area severity index (PASI) of ≥10%.
排除标准
- •1-Patients aged < 18 years or > 65 years 2-Pregnant and lactating mothers 3-Significant pulmonary/cardiovascular/hepato-renal dysfunction 4-Known cases of Immunocompromised states (HIV/ AIDS, etc.) 5-Patient not willing to attend treatment schedule regularly.
结局指标
主要结局
The response to treatment will be assessed using the following parameters:
时间窗: at base line,4wk,8wk,12wk
1. Reduction in Psoriasis Area Severity Index (PASI)
时间窗: at base line,4wk,8wk,12wk
2-Improvement in Investigators Global Assessment (IGA)
时间窗: at base line,4wk,8wk,12wk
3-Patient’s Global Assessment (PGA) on VAS
时间窗: at base line,4wk,8wk,12wk
次要结局
- To compare the improvement in quality of life in patients with Psoriasis by PGA ON VAS and IGA(at base line,4wk,8wk and 12wk)