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

Last updated: March 29, 2025
Sponsor: Indonesia University
Overall Status: Active - Recruiting

Phase

4

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Diabetes And Hypertension

Treatment

Placebo

Propolis drops

Clinical Study ID

NCT06903546
24-10-1677
  • Ages 35-59
  • All Genders

Study 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

Inclusion Criteria:

  • Controlled Diabetes Mellitus type 2 with HbA1c <7.5%

  • BMI 23-35 kg/m2

  • On anti-cholesterol therapy

Exclusion

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

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
March 18, 2025
Estimated Completion Date:
July 31, 2025

Study 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

Connect with a study center

  • University of Indonesia Faculty of Biomedical Science

    Jakarta, 10430
    Indonesia

    Active - Recruiting

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