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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:
Subject allocation into groups will be made by third party to ensure masking/ blinding protocol.
Data that will be taken from participants :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propolis drops | Drug | The intervention given is propolis drops that are approved by Indonesian Food and Drug Authority |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Male and female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dwirini R Gunarti, Biomed Science | Contact | +62 8118382301 | rinairet@gmail.com | |
| Wiryani Sentosa, MD | Contact | +62 81210977847 | wiryani@ymail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dwirini R Gunarti, Biomed Science | Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Indonesia Faculty of Biomedical Science | Recruiting | Jakarta | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31086222 | Background | 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. | |
| 28285617 |
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Confidentiality issue
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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| Placebo | Other | The given placebo are look-alike substance with no effect |
|
| 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. |
| D004700 | Endocrine System Diseases |