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临床试验/CTRI/2025/12/098406
CTRI/2025/12/098406尚未招募2/3 期

A Randomized,Parallel Group,Open Label,Active Controlled Clinical Study To Evaluate The Safety And Efficacy Of A Topical Unani Formulation Compared With Clobetasol Propionate In The Management Of Nar Farsi(Eczema)

National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月28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 EASI Score from baseline to 8 weeks of treatment

研究概览

简要总结

Eczema (Nar Farsi) is a prevalent and distressing skin condition affecting individuals of all ages, with rising global incidence. It significantly impacts quality of life through physical discomfort, psychological stress, and financial burden. Conventional treatments, especially topical corticosteroids, though effective in the short term, pose risks with long-term use and may lead to treatment failure or adverse effects. Dimad, a traditional Unani formulation, is historically used for managing inflammatory skin conditions like eczema. Given the growing need for safer, effective alternatives, this study aims to evaluate the safety and efficacy of Dimad compared to Clobetasol Propionate in managing Nar Farsi (Eczema).

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

  • The following participants will be included in the study: 1)Participants of any sex aged between 18 to 60 years 2)Participants having the following symptoms: Erythema Scaling Excoriation Hyperpigmentation Burning sensation Itching.

排除标准

  • The following participants will be excluded: 1)Participants aged less than 18 years or more than 60 years 2)Participants on concomitant therapy.
  • Known case of Diabetes mellitus.
  • Pregnant or Lactating Women.
  • Significant Pulmonary,Cardiovascular,Hepato-renal Dysfunction.
  • Known cases of Immunocompromised states (HIV,AIDS, etc.),malignancies.

结局指标

主要结局

Change in EASI Score from baseline to 8 weeks of treatment

时间窗: at baseline,2,4,6,8 week

次要结局

  • 1)Change in CDSQ score from baseline to 8 week.(2)systemic safety assessment.)

研究者

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

DR ANSARI HINA KAUSAR MOHAMMAD JALIL

National Research Institute Of Unani Medicine For Skin Disorders(NRIUMSD)

研究点 (1)

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