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

University of Putra Malaysia (UPM)

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Obesity

Treatments: Dietary Supplement: Cosmos Caudatus

Study type: Interventional

Funder types: Other

Identifiers

NCT02322268

6370700

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Diabetic Cosmos caudatus treated group

Experimental group

Description:

Subjects in this arm will receive Cosmos caudatus for 8 weeks.

Treatment:

Dietary Supplement: Cosmos Caudatus

Diabetic control group

No Intervention group

Description:

Subject in this group will not receive Cosmos caudatus. However, they will be educated for the same calorie intake and lifestyle intervention as in Cosmos caudatus treated group.