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

ConditionDiabetes Mellitus Type 2

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age35-59

SponsorIndonesia University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Controlled Diabetes Mellitus type 2 with HbA1c <7.5%

BMI 23-35 kg/m2

On anti-cholesterol therapy

Disqualifiers

Using injection therapy (insulin or GLP-1 RA)

History of bees product allergy

Active smoker

Consuming alcohol

Trial design

Design model

Parallel

Treatments tested in this trial

Propolis drops
Drug
The intervention given is propolis drops that are approved by Indonesian Food and Drug Authority
Placebo
Other intervention
The given placebo are look-alike substance with no effect

Treatment groups

64 Participants

are divided into 2 treatment groups

Group A: Intervention groupExperimental treatment 1 intervention

Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Low Density Lipoprotein

LDL level will be measured twice, before and after intervention

Time frame

8 weeks

High Density Lipoprotein

HDL will be measured twice, before and after intervention

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indonesia University

Lead sponsor

Source ClinicalTrials.gov

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