Shilajit与安慰剂治疗2019年中度冠状病毒病患者：一项三盲随机对照试验方案

IF 1.7 Q2 Medicine

Advances in integrative medicine Pub Date : 2025-04-26 DOI:10.1016/j.aimed.2025.100496

Narjes Bahri , Sareh Dashti , Fatemeh Mohammadzadeh , Milad Iranshahy , Roya Rahimi , Farnoosh Sharifi Mood , Tahereh Fathi Najafi

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引用次数: 0

摘要

2019冠状病毒病（COVID-19）已成为全球紧急情况。尽管疫苗开发取得了进展，但尚未发现针对COVID-19的有效药物。本研究旨在评估Shilajit对COVID-19严重程度、住院时间和死亡率的影响。方法本3期平行组三盲随机对照试验将在伊朗戈纳巴德Bohlool Gonabadi医院COVID病房对110例确诊为COVID-19的患者进行研究。随机化将使用可变大小（2和4）的排列块随机化方法来完成。干预组的参与者将每天服用100 毫克Shilajit（两粒500 毫克胶囊），而对照组将服用安慰剂胶囊，为期两周。研究结果包括干预第14天的临床改善。因此，两组患者的咳嗽、头痛、喉咙痛、寒战、嗅觉障碍、肌痛、腋窝温度和SPO2: FiO2比值将在基线和干预第14天记录。本研究的发现可能有助于医生使用传统药物作为COVID-19症状管理的辅助治疗。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Shilajit versus placebo in the management of patients with moderate coronavirus disease 2019: A triple-blind randomized controlled trial protocol

Background

Coronavirus disease 2019 (COVID-19) has become a global emergency. Regardless of the progress in vaccine development, no effective medication has yet been identified for COVID-19. This study aims to evaluate the effects of Shilajit on COVID-19 severity, admission duration, and mortality.

Methods

This phase 3 parallel-group triple-blind randomized controlled trial will be conducted on 110 patients with a documented diagnosis of COVID-19 in the COVID ward of the Bohlool Gonabadi Hospital, Gonabad, Iran. Randomization will be done using the permuted block randomization approach with variable sizes (2 and 4). Participants in the intervention group will receive 100 mg Shilajit (two 500 mg capsules) per day, while the control group will receive placebo capsules for two weeks. Study outcomes include clinical improvement at day 14 of the intervention. Therefore, the presence of cough, headache, sore throat, chills, smell disorder, myalgia, axillary temperature, and SPO2: FiO2 ratio will be recorded at baseline and day 14 of the intervention for patients in both groups.

Discussion

This study's findings may help physicians use a traditional medicine agent as an adjuvant treatment for symptomatic management of COVID-19.

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来源期刊

Advances in integrative medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

3.20

自引率

11.80%

发文量

审稿时长

15 weeks

期刊介绍： Advances in Integrative Medicine (AIMED) is an international peer-reviewed, evidence-based research and review journal that is multi-disciplinary within the fields of Integrative and Complementary Medicine. The journal focuses on rigorous quantitative and qualitative research including systematic reviews, clinical trials and surveys, whilst also welcoming medical hypotheses and clinically-relevant articles and case studies disclosing practical learning tools for the consulting practitioner. By promoting research and practice excellence in the field, and cross collaboration between relevant practitioner groups and associations, the journal aims to advance the practice of IM, identify areas for future research, and improve patient health outcomes. International networking is encouraged through clinical innovation, the establishment of best practice and by providing opportunities for cooperation between organisations and communities.