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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 December 2015 |
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Main ID: |
NCT02322268 |
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Date of registration:
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20/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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RCT Evaluating Effects of Cosmos Caudatus (Ulam Raja) in T2DM Patients
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Scientific title:
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Metabolomic Profiling on The Effect of Cosmos Caudatus (Ulam Raja) Supplementation in Patients With Type 2 Diabetes: A Randomized Controlled Trial |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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101 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02322268 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Shi Hui Cheng |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universiti Putra Malaysia |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Type 2 Diabetes Mellitus
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Intervention(s)
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Dietary Supplement: Cosmos Caudatus
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Primary Outcome(s)
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Glycemic control
[Time Frame: 1 month]
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Secondary Outcome(s)
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Metabolite profile
[Time Frame: 1 month]
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Liver profile
[Time Frame: 1 month]
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Inflammatory marker
[Time Frame: 1 month]
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Renal profile
[Time Frame: 1 month]
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Blood pressure
[Time Frame: 1 month]
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Lipid profile
[Time Frame: 1 month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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