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临床试验/CTRI/2024/06/068896
CTRI/2024/06/068896尚未招募2/3 期

A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of Safūf-i-Chobchīnī and Ravghan-i-Rāl in the Management of Taqashshur al-Jild (Psoriasis)

National Research Institute of Unani Medicine for Skin Disorders1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月14日最近更新:

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
Change in mean PASI Score from baseline to 2nd,4th and 8th week post treatment

研究概览

简要总结

The reported prevalence of psoriasis in countries ranges between 0.09%-11.4% making psoriasis a serious global problem. In India the prevalence of psoriasis varies from 0.44-2.8%.The conventional therapy has a good effect but has its own side effects like nausea, hyperpigmentation, pruritis, photo toxicity with serious complications such as skin carcinoma, hepatotoxicity and also worsening of disease. There are several single as well as compound Unani drugs which are in use for centuries for effectively treating taqashshur al-jild but many of them have not been evaluated clinically on scientific parameters. keeping this in view, this Randomized, Parallel Group, Open Label, Active Controlled Clinical Study is designed to evaluate the safety and efficacy of SafÅ«f-i-ChobchÄ«nÄ« and Ravghan-i-Rāl in management of Taqashshur al-Jild(Psoriasis). participants fulfilling inclusion criteria and exclusion criteria will receive either test or control drug as per randomization, in test drug participants will start with SafÅ«f-i-ChobchÄ«nÄ« (orally) and Ravghan-i-Rāl (Topically), in control participants will start with Psoralen(orally) and petroleum jelly(Topically). At baseline,2nd week and last follow up laboratory investigations will be done. Duration of study is 08 weeks.

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

  • Patients of any sex aged between 18-60 years of age, Patients clinically diagnosed with Taqashshur al-Jild (Psoriasis), Psoriasis area severity index (PASI) ≥10%.

排除标准

  • Pregnant or Lactating Women, Significant Pulmonary/Cardiovascular/ Hepato-renal Dysfunction, Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies, Patients with Psoriatic arthritis, Erythrodermic psoriasis.

结局指标

主要结局

Change in mean PASI Score from baseline to 2nd,4th and 8th week post treatment

时间窗: 56 DAYS

次要结局

  • Change in DLQI assessment will be done at 2nd,4th & 8th week post treatment(56 DAYS)

研究者

发起方
National Research Institute of Unani Medicine for Skin Disorders
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sadiya Siddiqua

National Research Institute Of Unani Medicine For Skin Disorders

研究点 (1)

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