RCT Evaluating Effects of Cosmos Caudatus (Ulam Raja) in T2DM Patients
Metabolomic Profiling on The Effect of Cosmos Caudatus (Ulam Raja) Supplementation in Patients With Type 2 Diabetes: A Randomized Controlled Trial
1 other identifier
interventional
101
1 country
1
Brief Summary
The purpose of this study is to determine whether Cosmos caudatus is effective as an adjuvant therapy for type 2 Diabetes Mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes-mellitus
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 20, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedDecember 2, 2015
November 1, 2015
1.3 years
December 20, 2014
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycemic control
1 month
Secondary Outcomes (6)
Liver profile
1 month
Renal profile
1 month
Blood pressure
1 month
Metabolite profile
1 month
Inflammatory marker
1 month
- +1 more secondary outcomes
Study Arms (2)
Diabetic Cosmos caudatus treated group
EXPERIMENTALSubjects in this arm will receive Cosmos caudatus for 8 weeks.
Diabetic control group
NO INTERVENTIONSubject 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.
Interventions
15g of Cosmos caudatus consumed with lunch or dinner
Eligibility Criteria
You may qualify if:
- Confirmed type 2 diabetes with at least 6 months diagnosis
- BMI between 18.5-40 kg/ m2
- Able to comply to the study protocol
- They are treated with stabilized dose of oral diabetic agents
You may not qualify if:
- Pregnant and lactating
- Have any gastrointestinal disorder that interferes the bowel function, severe hepatic or renal disease (dialysis), an infection that requires antibiotics within three weeks
- They are currently on insulin regimen.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Serdang
Serdang, Selangor, 43400, Malaysia
Related Publications (1)
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.
PMID: 26920910DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shi Hui Cheng
Universiti Putra Malaysia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cheng Shi Hui
Study Record Dates
First Submitted
December 20, 2014
First Posted
December 23, 2014
Study Start
August 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
December 2, 2015
Record last verified: 2015-11