RCT Evaluating Effects of Cosmos Caudatus (Ulam Raja) in T2DM Patients
NCT ID: NCT02322268
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2014-08-31
2015-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Diabetic Cosmos caudatus treated group
Subjects in this arm will receive Cosmos caudatus for 8 weeks.
Cosmos Caudatus
15g of Cosmos caudatus consumed with lunch or dinner
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.
No interventions assigned to this group
Interventions
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Cosmos Caudatus
15g of Cosmos caudatus consumed with lunch or dinner
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
30 Years
65 Years
ALL
No
Sponsors
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Universiti Putra Malaysia
OTHER
Responsible Party
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Cheng Shi Hui
Cheng Shi Hui
Principal Investigators
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Shi Hui Cheng
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Locations
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Hospital Serdang
Serdang, Selangor, Malaysia
Countries
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References
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Cheng SH, Ismail A, Anthony J, Ng OC, Hamid AA, Yusof BN. Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: Study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016 Feb 27;16:84. doi: 10.1186/s12906-016-1047-7.
Related Links
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Type 2 Diabetes
Medlineplus
Other Identifiers
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6370700
Identifier Type: -
Identifier Source: org_study_id