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Ushba丸剂口服及Raal软膏局部外用治疗体癣的疗效与安全性——一项随机开放标签活性对照临床试验

Efficacy and safety of Majoon Ushba oral and Marham Raal topical in tinea corporis - A randomized open-labeled active-controlled clinical trial.

作者信息

Ahmad Musab, Mobeen Abdul

机构信息

Dept. of Moalajat, Hakeem Rais Unani Medical College and Hospital, Sambhal, Uttar Pardesh, India.

Dept. of Moalajat, National Institute of Unani Medicine, Bangalore 560091, India.

出版信息

Explore (NY). 2023 Sep-Oct;19(5):681-688. doi: 10.1016/j.explore.2023.01.005. Epub 2023 Jan 25.

Abstract

OBJECTIVE

Tinea Corporis is the most frequent form of dermatophytosis reported as the commonest presentation. Majoon Ushba (MU) a polyherbal preparation in a semisolid oral dosage form and Marham Raal (MR) an ointment made up of herbal and animal drugs are used for skin disorders in Unai medicine. Considering the biologically active substances with antioxidant, antimicrobial, antifungal, anti-inflammatory, and wound-healing properties of their ingredients, this study aimed to evaluate the clinical and mycological efficacy and safety of MU and MR in tinea corporis.

METHODS

This randomized open-labeled active-controlled clinical trial was conducted on 42 patients of tinea corporis. Patients were randomly assigned via a computer-generated list to the test group (n=21) receiving oral MU (6 gm) with topical MR and the control group (n=21) topical terbinafine hydrochloride (1%) for 40 days. The severity scores of clinical symptoms; erythema, scaling, itching, margins, and size were the primary outcome and the mycological cure (negative KOH microscopy), total score, and dermatology life quality index (DLQI) were the secondary outcomes were analyzed at baseline and at 40 days.

RESULTS

A significant reduction was observed in clinical severity scores of erythema, scaling, and itching (P ≤ 0.05) in both groups except for margins, and size of the lesion (P ≥ 0.05). The mycological cure (P = .001) and the total score (P = 0.0002) and DLQI (P = 0.002) were statistically significant in both groups when analyzed from baseline to the end of the treatment within groups, however, the differences in these outcomes were statistically insignificant (P ≥ 0.05) on the inter-group comparison. All the safety parameters (clinical and laboratory) were in the normal range in both groups.

CONCLUSION

The results demonstrated that traditional and conventional treatments were equally effective and MU and MR can be prescribed as alternative or complementary treatments for tinea corporis.

摘要

目的

体癣是最常见的皮肤癣菌病类型。Majoon Ushba(MU)是一种半固体口服剂型的多草药制剂,Marham Raal(MR)是一种由草药和动物药物制成的软膏,在尤纳伊医学中用于治疗皮肤疾病。考虑到其成分具有抗氧化、抗菌、抗真菌、抗炎和伤口愈合特性的生物活性物质,本研究旨在评估MU和MR治疗体癣的临床和真菌学疗效及安全性。

方法

本随机开放标签活性对照临床试验对42例体癣患者进行。通过计算机生成的列表将患者随机分配至试验组(n = 21),接受口服MU(6克)加外用MR,以及对照组(n = 21),外用1%盐酸特比萘芬,治疗40天。临床症状的严重程度评分,即红斑、脱屑、瘙痒、边缘和大小,为主要结局指标;真菌学治愈(氢氧化钾显微镜检查阴性)、总分和皮肤病生活质量指数(DLQI)为次要结局指标,在基线和40天时进行分析。

结果

两组除皮损边缘和大小外(P≥0.05),红斑、脱屑和瘙痒的临床严重程度评分均显著降低(P≤0.05)。从基线到治疗结束在组内分析时,两组的真菌学治愈(P = 0.001)、总分(P = 0.0002)和DLQI(P = 0.002)均具有统计学意义,然而,在组间比较时,这些结局的差异无统计学意义(P≥0.05)。两组所有安全性参数(临床和实验室)均在正常范围内。

结论

结果表明,传统治疗和常规治疗同样有效,MU和MR可作为体癣的替代或补充治疗药物。

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