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草药乌纳尼配方治疗慢性斑块型银屑病的疗效和安全性:一项单臂临床试验。

The Efficacy and Safety of Herbal Unani Formulations in Chronic Plaque Psoriasis: A Single-arm Clinical Trial.

出版信息

Altern Ther Health Med. 2023 Oct;29(7):210-215.

PMID:35951063
Abstract

BACKGROUND

Despite there being advanced treatment options, psoriasis remains an incurable and recurring disease. Noteworthy scholars of Unani (Greco-Arab) medicine have proposed many drugs and formulations for psoriasis but the scientific evidence on the same is scarce. Hence, trial formulations were selected for the study.

PRIMARY STUDY OBJECTIVES

This study was designed to evaluate the efficacy and safety of two herbal Unani formulations, Ma΄jūn Mundī and Qairūtī Karnab, in the management of chronic plaque psoriasis (CPP).

METHODS/DESIGN: This open-label, single-arm clinical trial was conducted on 33 participants, of whom 30 completed the 12-week treatment course.

SETTING

This study was conducted at the Central Research Institute of Unani Medicine (CRIUM), Hyderabad, Telangana, India, from 01 August 2018 to 25 May 2019.

PARTICIPANTS

Participants of any gender aged 18 to 65 years with clinically diagnosed CPP and psoriasis area severity index (PASI) ≥ 10% were included in the trial.

INTERVENTIONS

The participants received 5 g of Ma΄jūn Mundī (a semisolid preparation) orally, twice daily with water, followed by the topical application of Qairūtī Karnab (a homogenous paste) to cover the lesions over 12 weeks.

OUTCOME MEASURES

The primary outcome measure was the change in PASI determined pre- and post-trial in terms of mean and percentage reduction. Secondary outcome measures were changes in patient global assessment (PGA) on a 100 mm visual analog scale, investigator global assessment (IGA) on a 6-point scale, and subjective parameters including erythema, induration, scaling, and itchiness.

RESULTS

The analysis revealed a significant reduction in the PASI score, with 12 subjects (40%) achieving PASI 75 and 3 subjects (10%) achieving PASI 90. Significant improvements were also observed in secondary outcome measures with no adverse events.

CONCLUSION

The findings of the study indicate that the trial formulations exhibit a notable anti-psoriatic effect without any adverse effects. The formulations are worthy of further evaluation as an alternative treatment for CPP.

摘要

背景

尽管有先进的治疗选择,银屑病仍然是一种无法治愈且会反复发作的疾病。著名的阿拉伯-希腊医学学者针对银屑病提出了许多药物和配方,但相关科学证据却很少。因此,选择了试验性配方进行研究。

主要研究目标

本研究旨在评估两种草药阿拉伯-希腊医学配方 Ma'jūn Mundī 和 Qairūtī Karnab 在治疗慢性斑块状银屑病(CPP)方面的疗效和安全性。

方法/设计:这是一项开放标签、单臂临床试验,共纳入 33 名参与者,其中 30 名完成了 12 周的治疗疗程。

地点

该研究于 2018 年 8 月 1 日至 2019 年 5 月 25 日在印度泰伦加纳邦海德拉巴的中央阿拉伯-希腊医学研究所(CRIUM)进行。

参与者

任何性别、年龄在 18 至 65 岁之间、经临床诊断患有 CPP 和银屑病面积严重程度指数(PASI)≥10%的参与者均被纳入研究。

干预措施

参与者口服 5 克 Ma'jūn Mundī(半固体制剂),每日两次,用温水送服,随后在 12 周内使用 Qairūtī Karnab(均匀糊剂)涂抹于病变部位。

结果

主要结局指标是通过试验前后的平均和百分比变化来衡量 PASI 的变化。次要结局指标包括患者整体评估(PGA)在 100 毫米视觉模拟量表上的变化、研究者整体评估(IGA)在 6 分制上的变化以及主观参数(包括红斑、硬结、脱屑和瘙痒)的变化。

分析结果显示,PASI 评分显著降低,12 名受试者(40%)达到 PASI 75,3 名受试者(10%)达到 PASI 90。次要结局指标也有显著改善,无不良反应发生。

结论

研究结果表明,试验配方具有显著的抗银屑病作用,且无不良反应。这些配方值得进一步评估,作为 CPP 的替代治疗方法。

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