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

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 c...

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Main Authors: Cheng, Shi Hui, Ismail, Amin, Anthony, Joseph, Ooi, Chuan Ng, Abdul Hamid, Azizah, Mohd Yusof, Barakatun Nisak
Format: Article
Language:English
Published: BioMed Central 2016
Online Access:http://psasir.upm.edu.my/id/eprint/55599/1/Effect%20of%20Cosmos%20caudatus%20%28Ulam%20raja%29.pdf
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author Cheng, Shi Hui
Ismail, Amin
Anthony, Joseph
Ooi, Chuan Ng
Abdul Hamid, Azizah
Mohd Yusof, Barakatun Nisak
author_facet Cheng, Shi Hui
Ismail, Amin
Anthony, Joseph
Ooi, Chuan Ng
Abdul Hamid, Azizah
Mohd Yusof, Barakatun Nisak
author_sort Cheng, Shi Hui
collection UPM
description 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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spelling upm.eprints-555992017-08-14T03:31:51Z http://psasir.upm.edu.my/id/eprint/55599/ Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: study protocol for a randomized controlled trial Cheng, Shi Hui Ismail, Amin Anthony, Joseph Ooi, Chuan Ng Abdul Hamid, Azizah Mohd Yusof, Barakatun Nisak 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. BioMed Central 2016 Article PeerReviewed application/pdf en http://psasir.upm.edu.my/id/eprint/55599/1/Effect%20of%20Cosmos%20caudatus%20%28Ulam%20raja%29.pdf 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 10.1186/s12906-016-1047-7
spellingShingle Cheng, Shi Hui
Ismail, Amin
Anthony, Joseph
Ooi, Chuan Ng
Abdul Hamid, Azizah
Mohd Yusof, Barakatun Nisak
Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: study protocol for a randomized controlled trial
title Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: study protocol for a randomized controlled trial
title_full Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: study protocol for a randomized controlled trial
title_fullStr Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: study protocol for a randomized controlled trial
title_full_unstemmed Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: study protocol for a randomized controlled trial
title_short Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: study protocol for a randomized controlled trial
title_sort effect of cosmos caudatus ulam raja supplementation in patients with type 2 diabetes study protocol for a randomized controlled trial
url http://psasir.upm.edu.my/id/eprint/55599/1/Effect%20of%20Cosmos%20caudatus%20%28Ulam%20raja%29.pdf
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