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Effects of Ziziphus jujuba on the Prevention of Drug Induced Liver Enzyme Disorders in Pulmonary Tuberculosis Patients: Protocol for Randomized controlled trial
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Seyedeh Zahra Maddahi  , Assie Jokar , Nasser Behnampur , Mohammad Kamalinejad , Moloud Fakhri |
| Department of Biostatistics, Health Management and Social Development Research Center, Golestan University of Medical Sciences, Gorgan, Iran |
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Abstract: (421 Views) |
Liver damage is the most common complication of anti-tuberculosis drugs, but there is currently no standard prevention for it. The main purpose of this study is to determine the effectiveness of Ziziphus jujuba (Z. jujuba) syrup on the prevention of liver enzyme disorder in TB patients.
This study is a protocol for randomized controlled trial. 48 patients will be included in the study who will be randomly assigned to one of the two groups of Z. jujuba syrup or placebo syrup based on the block randomization. Liver enzyme tests are measured at the beginning of the study, as well as days 14 and 28 of the study, which will be the primary outcome. The standard Visual Analog Scales questionnaire will be completed on days 0, 14, and 28 to assess cough, anorexia, and nausea in patients. The standard SF-36 quality of life questionnaire will be completed on days 0 and 28 of the study, which will be evaluated as the secondary outcome of the study.
The hypothesis of the study is that the incidence rate of liver enzyme disorder will be lower in patients treated with Z. jujuba, compared to those who received the placebo.
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| Keywords: Tuberculosis, Ziziphus jujuba, Liver enzyme disorder, Protocol study, Clinical trial |
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Full-Text [PDF 327 kb]
(204 Downloads)
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Type of Study: Review Article |
Subject:
Pharmacology
Received: 2021/12/8 | Accepted: 2022/08/20 | Published: 2023/02/16
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