NCT06903546 The Effect of Propolis Administration on Cholesterol Level in Diabetic Type 2 Patients
| NCT ID | NCT06903546 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Universitas Indonesia |
| Condition | Diabetes Mellitus Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 64 participants in total. It began in 2025-03-18 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if propolis administration works to change the level of Low Density Lipoprotein (LDL) and High Density Lipoprotein cholesterol (HDL) in diabetic type 2 patients. The main questions it aims to answer are: \- Is giving 1 drops/ 10kg/ times, twice daily for 8 weeks will change the level of LDL and HDL level in diabetic type 2 patients compared to placebo? Researchers will compare propolis to a placebo (a look-alike substance that contains no drug) to see if propolis works to change LDL and HDL cholesterol level. Participants will: * Take propolis or a placebo, 2 times daily with given dose (1 drops/10 kg/times) every day for 2 months * Visit the sub-district health centre once every 2 weeks for checkups * Get their blood checked before and after intervention
Eligibility Criteria
Inclusion Criteria: * Controlled Diabetes Mellitus type 2 with HbA1c \<7.5% * BMI 23-35 kg/m2 * On anti-cholesterol therapy Exclusion Criteria: * Using injection therapy (insulin or GLP-1 RA) * History of bees product allergy * Active smoker * Consuming alcohol * Altered liver (ALT\>35 IU/L) and kidney (eGFR\<90 mL/min) function * Pregnant and breastfeeding women * History of cardiovascular disease (heart attack, stroke)
Contact & Investigator
Dwirini R Gunarti, Biomed Science
PRINCIPAL INVESTIGATOR
Universitas Indonesia
Frequently Asked Questions
Who can join the NCT06903546 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 59 Years, studying Diabetes Mellitus Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06903546 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06903546 currently recruiting?
Yes, NCT06903546 is actively recruiting participants. Contact the research team at rinairet@gmail.com for enrollment information.
Where is the NCT06903546 trial being conducted?
This trial is being conducted at Jakarta, Indonesia.
Who is sponsoring the NCT06903546 clinical trial?
NCT06903546 is sponsored by Universitas Indonesia. The principal investigator is Dwirini R Gunarti, Biomed Science at Universitas Indonesia. The trial plans to enroll 64 participants.
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