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

University of Indonesia (UI)

Status and phase: Enrolling; Phase 4

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Propolis drops; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06903546

24-10-1677

Details and patient eligibility

About

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

Full 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

Enrollment: 64 estimated patients

Sex: All

Ages: 35 to 59 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

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)

Treatment:

Drug: Propolis drops

Control group

Placebo Comparator group

Description:

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)

Treatment:

Other: Placebo