Diabetes Mellitus, Type 2Phase 1/2NCT05407467
KurCoSmart Effects on People With Type 2 DM
A Phase 1/2 study testing Curcumin and virgin coconut oil extract (KurCo Smart) in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial summary
The investigators aim to evaluate the effect of curcumin and virgin coconut oil extract supplementation on people with type 2 DM, including blood glucose, HbA1c levels, inflammation, body weight and insulin resistance evaluation Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Resistance, Inflammation
- What is being tested?
- Curcumin and virgin coconut oil extract (KurCo Smart)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- Jun 2022to Sep 2022
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed Type 2 DM
- Signing consent form
Who cannot join
- Pregnant or breastfeeding
- Multiple organ failure
- History of hypersensitivity reaction to curcumin and virgin coconut oil
- Cancer, renal insufficiency, hematological disease, acute heart failure, chronic liver disease
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
UNS Hospital
Sukoharjo, Central Java, 57161
Desy Puspa Putri, Master, +6281283284827, desypuspa@staff.uns.ac.id
Nurhasan Agung Prabowo, Master
About this study
Official title: KurCoSmart Effects on People With Type 2 DM: a Randomized, Open Trial
The investigators aim to evaluate the effect of curcumin and virgin coconut oil extract supplementation on people with type 2 DM, including blood glucose, HbA1c levels, inflammation, body weight and insulin resistance evaluation
Read the detailed description
The investigators give Kurcosmart supplementation aside from diabetes standard treatment to evaluate its benefits on people with type 2 DM, considering its effect on controlling fasting and prandial blood glucose, reducing HbA1c level, controlling inflammation degree; and repairing insulin resistance
- Being tested
- Curcumin and virgin coconut oil extract (KurCo Smart)
- Keywords
- curcumin, coconut oil, diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Inflammation, Body Weight, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin and virgin coconut oil extract (KurCo Smart)Dietary supplement
we give 2 tablets of curcumin and virgin coconut oil extract thrice a day for 30 days and evaluate the result
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | There is no additional intervention other than subject's standard diabetes treatment |
| Interventional Group | Experimental | This group will received additional supplementation of curcumin and virgin coconut oil aside from their standard treatment Receives: Dietary Supplement: Curcumin and virgin coconut oil extract (KurCo Smart) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Subject's fasting and prandial blood glucose
Measured: Change of Blood glucose at 1 months
Inflammation degree
Subject's high sensitivity C-reactive protein level
Measured: Change of hs-CRP at 1 Months
insulin resistance
Subject's HOMA IR
Measured: Change of HOMA IR at 1 Months
HbA1c
Subject's glycated haemoglobin level
Measured: Change of HbA1C at 1 Months
Secondary outcomes (2)
Body Mass Index
Subject's height and body weight
Measured: Change of BMI at 1 Months
Blood Pressure
Subject's blood pressure
Measured: Change fof blood prssure at 1 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhasan Agung Prabowo, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407467
- Sponsor's protocol ID
- KurCoSmart
- Status last verified
- Jun 2022
- First submitted
- 18 May 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be restricted for this study purpose only
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KurCoSmart Effects on People With Type 2 DM: a Randomized, Open Trial
- ClinicalTrials.gov ID
- NCT05407467
- Acronym / sponsor ID
- KurCoSmart
- Keywords
- curcumin, coconut oil, diabetes mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 7 Jun 2022 (actual)
- 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 investigators aim to evaluate the effect of curcumin and virgin coconut oil extract supplementation on people with type 2 DM, including blood glucose, HbA1c levels, inflammation, body weight and insulin resistance evaluation
Detailed description
The investigators give Kurcosmart supplementation aside from diabetes standard treatment to evaluate its benefits on people with type 2 DM, considering its effect on controlling fasting and prandial blood glucose, reducing HbA1c level, controlling inflammation degree; and repairing insulin resistance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –There is no additional intervention other than subject's standard diabetes treatment |
| Interventional Group | Experimental | Dietary Supplement: Curcumin and virgin coconut oil extract (KurCo Smart)This group will received additional supplementation of curcumin and virgin coconut oil aside from their standard treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed Type 2 DM
- Signing consent form
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- Multiple organ failure
- History of hypersensitivity reaction to curcumin and virgin coconut oil
- Cancer, renal insufficiency, hematological disease, acute heart failure, chronic liver disease
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 |
|---|---|---|
| Curcumin and virgin coconut oil extract (KurCo Smart)we give 2 tablets of curcumin and virgin coconut oil extract thrice a day for 30 days and evaluate the result | Dietary supplement | Interventional Group |
Primary outcome
Blood glucose
Time frame: Change of Blood glucose at 1 months
Subject's fasting and prandial blood glucose
Inflammation degree
Time frame: Change of hs-CRP at 1 Months
Subject's high sensitivity C-reactive protein level
insulin resistance
Time frame: Change of HOMA IR at 1 Months
Subject's HOMA IR
HbA1c
Time frame: Change of HbA1C at 1 Months
Subject's glycated haemoglobin level
2 secondary outcomes
Body Mass Index
Time frame: Change of BMI at 1 Months
Blood Pressure
Time frame: Change fof blood prssure at 1 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: No. Individual participant data will be restricted for this study purpose only
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Curcumin and virgin coconut oil extract (KurCo Smart) in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by Universitas Sebelas Maret at 1 site in Indonesia.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Jun 2022. 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 Indonesia. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nurhasan Agung Prabowo, MD (6282328010430, dr.Nurhasan21@staff.uns.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (time frame: Change of Blood glucose at 1 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2022; AzTrials last refreshed its copy on 1 Nov 2026.