The Effect of Propolis Administration on Cholesterol Level in Diabetic Type 2 Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Propolis drops, Placebo.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus Type 2. Basic parameters: 35 years — 59 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Propolis Administration on Low Density Lipoprotein and High Density Lipoprotein in Diabetic Type 2 Patients in Central Jakarta
Overview
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
Interventions
- Drug Propolis drops
The intervention given is propolis drops that are approved by Indonesian Food and Drug Authority - Other Placebo
The given placebo are look-alike substance with no effect
Primary outcome measures
- Low Density Lipoprotein [Time frame: 8 weeks]
- High Density Lipoprotein [Time frame: 8 weeks]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Indonesia · 1 center
- University of Indonesia Faculty of Biomedical Science — Jakarta
Publications
- 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
- 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
Identifiers
NCT: NCT06903546 · 24-10-1677