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Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: study protocol for a randomized controlled trial


Citation

Cheng, Shi Hui and Ismail, Amin and Anthony, Joseph and Ooi, Chuan Ng and Abdul Hamid, Azizah and Mohd Yusof, Barakatun Nisak (2016) Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: study protocol for a randomized controlled trial. BMC Complementary and Alternative Medicine, 16 (84). pp. 1-8. ISSN 1472-6882

Abstract

BACKGROUND: Type 2 diabetes mellitus is a major health threat worldwide. Cosmos caudatus is one of the medicinal plants used to treat type 2 diabetes. Therefore, this study aims to determine the effectiveness and safety of C. caudatus in patients with type 2 diabetes. Metabolomic approach will be carried out to compare the metabolite profiles between C. Caudatus treated diabetic patients and diabetic controls. METHODS AND DESIGN: This is a single-center, randomized, controlled, two-arm parallel design clinical trial that will be carried out in a tertiary hospital in Malaysia. In this study, 100 patients diagnosed with type 2 diabetes will be enrolled. Diabetic patients who meet the eligibility criteria will be randomly allocated to two groups, which are diabetic C. caudatus treated(U) group and diabetic control (C) group. Primary and secondary outcomes will be measured at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy. DISCUSSION: The study will be the first randomized controlled trial to assess whether C. caudatus can confer beneficial effect in patients with type 2 diabetes. The results of this trial will provide clinical evidence on the effectiveness and safety of C. caudatus in patients with type 2 diabetes.


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Additional Metadata

Item Type: Article
Divisions: Faculty of Medicine and Health Science
DOI Number: https://doi.org/10.1186/s12906-016-1047-7
Publisher: BioMed Central
Keywords: Cosmos caudatus; Type 2 diabetes mellitus; Glycemic status; Metabolomic; Herbal medicine; Functional food; Dietary; Supplementation; Randomized controlled trial
Depositing User: Mohd Hafiz Che Mahasan
Date Deposited: 14 Aug 2017 03:31
Last Modified: 14 Aug 2017 03:31
Altmetrics: http://www.altmetric.com/details.php?domain=psasir.upm.edu.my&doi= 10.1186/s12906-016-1047-7
URI: http://psasir.upm.edu.my/id/eprint/55599
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