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

NCT06903546 | Recruiting Phase 4

• 1 other identifier: 24-10-1677
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus Type 2

Keywords

Propolis; Diabetes Mellitus Type 2; Low Density Lipoprotein; High Density Lipoprotein

Outcome Measures

Primary Outcomes (2)

• Low Density Lipoprotein

  LDL level will be measured twice, before and after intervention

  8 weeks

• High Density Lipoprotein

  HDL will be measured twice, before and after intervention

  8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Drug: Propolis drops

Control group

PLACEBO COMPARATOR

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)

Other: Placebo

Interventions

Propolis drops DRUG

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

Intervention group

Placebo OTHER

The given placebo are look-alike substance with no effect

Control group

Eligibility Criteria

• Age: 35 Years - 59 Years
• Gender Eligibility Details: Male and female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Controlled Diabetes Mellitus type 2 with HbA1c \<7.5%
• BMI 23-35 kg/m2
• On anti-cholesterol therapy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

University of Indonesia Faculty of Biomedical Science

Jakarta, 10430, Indonesia

RECRUITING

Related Publications (2)

• Zakerkish M, Jenabi M, Zaeemzadeh N, Hemmati AA, Neisi N. The Effect of Iranian Propolis on Glucose Metabolism, Lipid Profile, Insulin Resistance, Renal Function and Inflammatory Biomarkers in Patients with Type 2 Diabetes Mellitus: A Randomized Double-Blind Clinical Trial. Sci Rep. 2019 May 13;9(1):7289. doi: 10.1038/s41598-019-43838-8.

  PMID: 31086222 BACKGROUND

• Samadi N, Mozaffari-Khosravi H, Rahmanian M, Askarishahi M. Effects of bee propolis supplementation on glycemic control, lipid profile and insulin resistance indices in patients with type 2 diabetes: a randomized, double-blind clinical trial. J Integr Med. 2017 Mar;15(2):124-134. doi: 10.1016/S2095-4964(17)60315-7.

  PMID: 28285617 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dwirini R Gunarti, Biomed Science

  Indonesia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dwirini R Gunarti, Biomed Science

CONTACT

+62 8118382301; rinairet@gmail.com

Wiryani Sentosa, MD

CONTACT

+62 81210977847; wiryani@ymail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The participants will be randomly allocated into two groups that will recieve either propolis or plasebo. The study model is double-blinded trial. The participants are patients undergoing treatment for type 2 diabetes in multiple sub-dictrict health centre in Central Jakarta and will be screened based on inclusion and exclusion criteria.

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: March 30, 2025
• Study Start: March 18, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)