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NCT Number: NCT06903546

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

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

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Indonesia Faculty of Biomedical Science

Jakarta, 10430, Indonesia

Location status: Recruiting

Location contact

Dwirini R Gunarti

CONTACT

[email protected]

+62 8118382301

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Propolis drops

Drug

The intervention given is propolis drops that are approved by Indonesian Food and Drug Authority

Placebo

Other

The given placebo are look-alike substance with no effect

Primary outcomes

  1. Low Density Lipoprotein

    Time frame: 8 weeks

    LDL level will be measured twice, before and after intervention

  2. High Density Lipoprotein

    Time frame: 8 weeks

    HDL will be measured twice, before and after intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Dwirini R Gunarti, Biomed Science

CONTACT

[email protected]

+62 8118382301

Wiryani Sentosa, MD

CONTACT

[email protected]

+62 81210977847

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

The Effect of Propolis Administration on Low Density Lipoprotein and High Density Lipoprotein in Diabetic Type 2 Patients in Central Jakarta

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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