The Effect of Propolis Administration on Cholesterol Level in Diabetic Type 2 Patients

Phase 4

Recruiting

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Propolis drops; Other: Placebo

• Registration Number: NCT06903546
• Lead Sponsor: Indonesia University

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

Detailed Description

Subject allocation into groups will be made by third party to ensure masking/ blinding protocol.

Data that will be taken from participants :

* Private information

* Medication history (for type 2 Diabetes Mellitus)

* Food intake (calories, fats, carbohydrate, protein, and flavonoid intake)

* Physical activity status

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-18
• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Last Update Submitted: 2025-03-29
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Propolis drops	This group will receive the intervention, which in this study is propolis with dose given 1 drop/kg/time given, 2 times daily, for 8 weeks (2 months)
Control group	Placebo	This group will receive placebo (a look-alike substance that contains no drug) with dose given 1 drop/kg/time given, 2 times daily, for 8 weeks (2 months)

Primary Outcome Measures

Name	Time	Method
Low Density Lipoprotein	8 weeks	LDL level will be measured twice, before and after intervention
High Density Lipoprotein	8 weeks	HDL will be measured twice, before and after intervention

Trial Locations

Locations (1)

University of Indonesia Faculty of Biomedical Science; 🇮🇩 Jakarta, Indonesia