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A multicentric study to measure the safety and efficacy of NuvastaticÂ(Interventional drug) in reducing fatigue caused by chemotherapy in patients with metastatic colorectal cancer receiving 5-fluorouracil.

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下载链接:
https://www.omicsdi.org/dataset/ecrin-mdr-crc/2600516
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资源简介:
Intervention1: Nuvastatic 1000 mg sachet containing effervescent powder manufactured by Natureceuticals Sdn Bhd, Malaysia: 1. Nuvastatic is to be consumed after meal, 1 sachet � 5 times a day. 2. Dissolve 1 sachet of Nuvastatic in 350 ml of lukewarm water and drink immediately after preparation. 3. Each sachet containing 1000 mg of standardized extract of O. stamineus Control Intervention1: Placebo sachet 1000 mg (containing all excipients except active ingredient): 1. Placebo is to be consumed after meal, 1 sachet � 5 times a day. 2. Dissolve 1 sachet of Placebo in 350 ml of lukewarm water and drink immediately after preparation. Primary outcome(s): Improvement in Chemotherapy-induced fatigue as assessed by FSS (Fatigue severity scale)Timepoint: Baseline (Cycle 2), and at each cycle till 6 Cycles, EOT and Follow-up Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Double Blind Double Dummy
创建时间:
2020-12-15
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