Type 2 Diabetes MellitusNCT02322268
RCT Evaluating Effects of Cosmos Caudatus (Ulam Raja) in T2DM Patients
A study testing Cosmos Caudatus in people with Type 2 Diabetes Mellitus and Obesity, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
The purpose of this study is to determine whether Cosmos caudatus is effective as an adjuvant therapy for type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity
- What is being tested?
- Cosmos Caudatus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteMalaysia
- Study dates
- Aug 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Being tested
- Cosmos Caudatus
- Keywords
- Type 2 Diabetes Mellitus, Cosmos Caudatus, Ulam Raja, Metabolomic profiling, antioxidant
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmos CaudatusDietary supplement
Also called Ulam Raja
15g of Cosmos caudatus consumed with lunch or dinner
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Cosmos caudatus treated group | Experimental | Subjects in this arm will receive Cosmos caudatus for 8 weeks. Receives: Dietary Supplement: Cosmos Caudatus |
| Diabetic control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Measured: 1 month
Secondary outcomes (6)
Liver profile
Measured: 1 month
Renal profile
Measured: 1 month
Blood pressure
Measured: 1 month
Metabolite profile
Measured: 1 month
Inflammatory marker
Measured: 1 month
Lipid profile
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Shi Hui, Universiti Putra Malaysia
- Investigators
- Shi Hui Cheng, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322268
- Sponsor's protocol ID
- 6370700
- Status last verified
- Nov 2015
- First submitted
- 20 Dec 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26920910
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Profiling on The Effect of Cosmos Caudatus (Ulam Raja) Supplementation in Patients With Type 2 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02322268
- Acronym / sponsor ID
- 6370700
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Keywords
- Type 2 Diabetes Mellitus, Cosmos Caudatus, Ulam Raja, Metabolomic profiling, antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Cosmos caudatus is effective as an adjuvant therapy for type 2 Diabetes Mellitus.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Cosmos caudatus treated group | Experimental | Dietary Supplement: Cosmos CaudatusSubjects in this arm will receive Cosmos caudatus for 8 weeks. |
| Diabetic control group | No intervention | –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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmos CaudatusAlso: Ulam Raja15g of Cosmos caudatus consumed with lunch or dinner | Dietary supplement | Diabetic Cosmos caudatus treated group |
Primary outcome
Glycemic control
Time frame: 1 month
6 secondary outcomes
Liver profile
Time frame: 1 month
Renal profile
Time frame: 1 month
Blood pressure
Time frame: 1 month
Metabolite profile
Time frame: 1 month
Inflammatory marker
Time frame: 1 month
Lipid profile
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Derived from this study: PubMed 26920910Cheng 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.
- Type 2 DiabetesLink provided by the sponsor.
- MedlineplusLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shi Hui Cheng principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosmos Caudatus in people with Type 2 Diabetes Mellitus and Obesity, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02322268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.