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NCT05407467 Clinical Trial

KurCoSmart Effects on People With Type 2 DM

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
KurCoSmart Effects on People With Type 2 DM: a Randomized, Open Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05407467
Other study ID # KurCoSmart
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date June 2022
Est. completion date September 2022

Study information
Verified date June 2022
Source Universitas Sebelas Maret
Contact Nurhasan Agung Prabowo, MD
Phone 6282328010430
Email dr.Nurhasan21@staff.uns.ac.id
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date September 2022
Est. primary completion date August 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Confirmed Type 2 DM - Signing consent form Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• 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

Locations
Country Name City State
Indonesia UNS Hospital Sukoharjo Central Java

Sponsors (1)
Lead Sponsor Collaborator
Universitas Sebelas Maret

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood glucose Subject's fasting and prandial blood glucose Change of Blood glucose at 1 months
Primary Inflammation degree Subject's high sensitivity C-reactive protein level Change of hs-CRP at 1 Months
Primary insulin resistance Subject's HOMA IR Change of HOMA IR at 1 Months
Primary HbA1c Subject's glycated haemoglobin level Change of HbA1C at 1 Months
Secondary Body Mass Index Subject's height and body weight Change of BMI at 1 Months
Secondary Blood Pressure Subject's blood pressure Change fof blood prssure at 1 Months
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