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

November 30, 2015 updated by: Cheng Shi Hui, Universiti Putra Malaysia

Metabolomic Profiling on The Effect of Cosmos Caudatus (Ulam Raja) Supplementation in Patients With Type 2 Diabetes: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Serdang, Selangor, Malaysia, 43400
        • Hospital Serdang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetic Cosmos caudatus treated group
Subjects in this arm will receive Cosmos caudatus for 8 weeks.
Dietary supplement: Cosmos Caudatus
15g of Cosmos caudatus consumed with lunch or dinner
Other Names:
  • Ulam Raja
No Intervention: Diabetic control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycemic control
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 1 month
1 month
Liver profile
Time Frame: 1 month
1 month
Renal profile
Time Frame: 1 month
1 month
Metabolite profile
Time Frame: 1 month
1 month
Inflammatory marker
Time Frame: 1 month
1 month
Lipid profile
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Investigators

  • Principal Investigator: Shi Hui Cheng, Universiti Putra Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

December 20, 2014

First Submitted That Met QC Criteria

December 20, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6370700

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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