RCT Evaluating Effects of Cosmos Caudatus (Ulam Raja) in T2DM Patients

Not Applicable

Completed

• Conditions: Obesity; Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: Cosmos Caudatus

• Registration Number: NCT02322268
• Lead Sponsor: Universiti Putra Malaysia

Brief Summary

The purpose of this study is to determine whether Cosmos caudatus is effective as an adjuvant therapy for type 2 Diabetes Mellitus.

Detailed Description

Background: Cosmos caudatus (C. caudatus) ethanol extract has been reported to have extraordinary high antioxidant capacity compared to other plants. Furthermore it has been shown to reduce the plasma blood glucose and lipid profile significantly in an animal model. However, no study has been reported on its effectiveness in human. Therefore, we plan to conduct a randomized controlled trial to evaluate the effectiveness and safety of C. caudatus on glycemic status, oxidative stress markers, inflammatory markers, lipid profile in patients with type 2 diabetes. Besides, metabolomics approach will be carried out to compare the metabolite changes between diabetic C. caudatus treated and control patients.

Methods: A single-center randomized, controlled, two-arm parallel design clinical trial will be carried out in Malaysia. This study enrol 92 patients diagnosed with type 2 diabetes. Diabetic patients who meet eligibility criteria will be randomly allocated to two groups, which are C. caudatus treatment group and control group. Both groups will be compared on the primary and secondary outcomes 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 provide insights into the potential beneficial effect of C. caudatus in type 2 diabetic patients. In addition, the therapeutic effect of C. caudatus towards type 2 diabetes will reflect as a change of metabolite profile in urine and serum.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-12-20
• Study First Submitted QC: 2014-12-20
• Study First Posted: 2014-12-23
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

1. Confirmed type 2 diabetes with at least 6 months diagnosis
2. BMI between 18.5-40 kg/ m2
3. Able to comply to the study protocol
4. They are treated with stabilized dose of oral diabetic agents

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Exclusion Criteria

1. Pregnant and lactating
2. Have any gastrointestinal disorder that interferes the bowel function, severe hepatic or renal disease (dialysis), an infection that requires antibiotics within three weeks
3. They are currently on insulin regimen.
4. Individuals on the following drugs which will possibly have herb-drug interaction: anticoagulant such as warfarin and aspirin, corticosteroids (Prednisolone), fluoroquinolones (ciprofloxacin, levofloxacin), doxorubicin, cisplatin, cyclosporine, and digoxin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetic Cosmos caudatus treated group	Cosmos Caudatus	Subjects in this arm will receive Cosmos caudatus for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Glycemic control	1 month

Secondary Outcome Measures

Name	Time	Method
Inflammatory marker	1 month
Blood pressure	1 month
Metabolite profile	1 month
Lipid profile	1 month
Liver profile	1 month
Renal profile	1 month

Trial Locations

Locations (1)

Hospital Serdang; 🇲🇾 Serdang, Selangor, Malaysia