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临床试验/CTRI/2025/03/082632
CTRI/2025/03/082632尚未招募2 期

Therapeutic efficacy of a topical unani formulation containing Sirka and Samgh-i-Arabi in the management of Quba Khabith (Tinea Corporis): An open labeled, randomised clinical trial with standard control

Central Council for Research in Unani Medicine CCRUM New Delhi India1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年10月4日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
1. Typical Lesion with itching, Scaling, Erythema, Papules, Vesicles

研究概览

简要总结

Tinea corporis is variously named ringworm, dermatophytosis, favus, or daad.It is a clinical condition caused by a fungal infection of the skin, hair, and nails. The fungus is keratophyllic affecting the outer layer of the skin to produce ring-shaped lesions with a papulo-vesicular margin and central clear area.  According to WHO estimates, tinea corporis infects between 20 to 25% of the world population. It occurs most frequently in post-pubertal children and young adults with no sex differentiation. Climate conditions all around the world have influenced the incidence variability. Many effective synthetic antifungal drugs have been discovered for the treatment of tinea corporis, but their use has remained limited due to various side effects. Unani herbal medicine, whether a single herb, compound formulations, or regimental therapy, has also been used for this purpose since ancient times. However, only a few of them have been evaluated on scientific grounds for their efficacy. The need of the hour is to validate the herbal preparations mentioned in our classical texts, which are otherwise safe, fairly available, and easily affordable by the general public, on scientific parameters. In this context, we selected a trial to evaluate the therapeutic efficacy of a topical unani formulation containing Sirka andSamgh -i-Arabi in the management of Quba Khabith (Tinea corporis), which is a randomized study with standard control.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

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 diagnosed with Quba Khabith (tinea corporis)
  • Patients in the age group of 18 to 60 irrespective of gender
  • KOH (potassium hydroxide) positive
  • Patients willing to sign written informed consent.

排除标准

  • Patients below the age of 18 years and above 60 years
  • History of drug-induced allergy
  • Pregnant or breastfeeding mothers
  • Active case of malignancy
  • Patients having diabetes mellitus or cardiovascular or renal diseases.
  • Unwillingness or inability to fulfill the protocol or patients who fail to consent.

结局指标

主要结局

1. Typical Lesion with itching, Scaling, Erythema, Papules, Vesicles

时间窗: 7th, 14th, 21st, and 28th day of the study. KOH will be assessed on 0th and 29th (before and after)

2. KOH (potassium hydroxide) Negative

时间窗: 7th, 14th, 21st, and 28th day of the study. KOH will be assessed on 0th and 29th (before and after)

3. TSSS (Total sign and symptoms score)

时间窗: 7th, 14th, 21st, and 28th day of the study. KOH will be assessed on 0th and 29th (before and after)

次要结局

  • 1. DLQI (Dermatology life quality index)(2. Pre and Post photograph of the lesion site)

研究者

发起方
Central Council for Research in Unani Medicine CCRUM New Delhi India
申办方类型
Research institution and hospital

研究点 (1)

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