Diabetes Mellitus Type 2Phase 4NCT06903546
The Effect of Propolis Administration on Cholesterol Level in Diabetic Type 2 Patients
A Phase 4 study testing Propolis drops in people with Diabetes Mellitus Type 2, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 59 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Propolis drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteIndonesia
- Study dates
- 18 Mar 2025to 31 Jul 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Controlled Diabetes Mellitus type 2 with HbA1c <7.5%
- BMI 23-35 kg/m2
- On anti-cholesterol therapy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
University of Indonesia Faculty of Biomedical Science
Jakarta, 10430
Dwirini R Gunarti, +62 8118382301, rinairet@gmail.com
About this study
Official title: The Effect of Propolis Administration on Low Density Lipoprotein and High Density Lipoprotein in Diabetic Type 2 Patients in Central Jakarta
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:
Read more
- 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
Read the 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
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Propolis drops, Placebo
- Keywords
- Propolis, Diabetes Mellitus Type 2, Low Density Lipoprotein, High Density Lipoprotein
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propolis dropsDrug
The intervention given is propolis drops that are approved by Indonesian Food and Drug Authority
PlaceboOther
The given placebo are look-alike substance with no effect
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Density Lipoprotein
LDL level will be measured twice, before and after intervention
Measured: 8 weeks
High Density Lipoprotein
HDL will be measured twice, before and after intervention
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start18 Mar 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. drg. Dwirini Retno Gunarti, M.S., Universitas Indonesia
- Investigators
- Dwirini R Gunarti, Biomed Science, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903546
- Sponsor's protocol ID
- 24-10-1677
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality issue
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.
PubMed 31086222Samadi 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.
PubMed 28285617
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Propolis Administration on Low Density Lipoprotein and High Density Lipoprotein in Diabetic Type 2 Patients in Central Jakarta
- ClinicalTrials.gov ID
- NCT06903546
- Acronym / sponsor ID
- 24-10-1677
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Propolis, Diabetes Mellitus Type 2, Low Density Lipoprotein, High Density Lipoprotein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Propolis dropsThis 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) |
| Control group | Placebo comparator | Other: PlaceboThis 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) |
Who may qualify
- Ages
- 35 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Controlled Diabetes Mellitus type 2 with HbA1c <7.5%
- BMI 23-35 kg/m2
- On anti-cholesterol therapy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propolis dropsThe intervention given is propolis drops that are approved by Indonesian Food and Drug Authority | Drug | Intervention group |
| PlaceboThe given placebo are look-alike substance with no effect | Other | Control group |
Primary outcome
Low Density Lipoprotein
Time frame: 8 weeks
LDL level will be measured twice, before and after intervention
High Density Lipoprotein
Time frame: 8 weeks
HDL will be measured twice, before and after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 31086222Zakerkish 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.
- Background: PubMed 28285617Samadi 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.
- Individual participant dataSharing planned: No. Confidentiality issue
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dwirini R Gunarti, Biomed Science principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propolis drops in people with Diabetes Mellitus Type 2, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dwirini R Gunarti, Biomed Science (+62 8118382301, rinairet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Density Lipoprotein (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06903546, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.