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

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ClinicalTrials.gov Identifier: NCT02322268
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Cheng Shi Hui, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Obesity Dietary Supplement: Cosmos Caudatus Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolomic Profiling on The Effect of Cosmos Caudatus (Ulam Raja) Supplementation in Patients With Type 2 Diabetes: A Randomized Controlled Trial
Study Start Date : August 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. Glycemic control [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Liver profile [ Time Frame: 1 month ]
  2. Renal profile [ Time Frame: 1 month ]
  3. Blood pressure [ Time Frame: 1 month ]
  4. Metabolite profile [ Time Frame: 1 month ]
  5. Inflammatory marker [ Time Frame: 1 month ]
  6. Lipid profile [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02322268


Locations
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Malaysia
Hospital Serdang
Serdang, Selangor, Malaysia, 43400
Sponsors and Collaborators
Universiti Putra Malaysia
Investigators
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Principal Investigator: Shi Hui Cheng Universiti Putra Malaysia

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cheng Shi Hui, Universiti Putra Malaysia
ClinicalTrials.gov Identifier: NCT02322268     History of Changes
Other Study ID Numbers: 6370700
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Cheng Shi Hui, Universiti Putra Malaysia:
Type 2 Diabetes Mellitus
Cosmos Caudatus
Ulam Raja
Metabolomic profiling
antioxidant
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases