- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05770297
Effect of Propolis Administration for Dysmenorrhea in Endometriosis Patient With Levonorgestrel Implant Therapy
Effect of Propolis Administration as Levonorgestrel (LNG) Implant Adjuvant for Dysmenorrhea in Endometriosis: Focus on Clinical Improvement, Oxidative Stress Biomarkers and Inflammation
The goal of this clinical trial is to investigate the effect of propolis administration on dysmenorrhea in endometriosis patient. the main questions it aims to answer are:
- Does the propolis administration reduce symptoms of dysmenorrhea in endometriosis?
- Does the propolis administration reduce the amount of oxidative stress biomarkers in endometriosis?
- Does the propolis administration reduce the amount of Inflammatory biomarkers in endometriosis?
Participants will be given an intervention in the form of propolis at a dose of 1 drop per 10 kilogram of body weight per administration, twice a day. there will be a control group that will be given an intervention in the form of a placebo containing 70% caramel alcohol dye solution.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jakarta Pusat
-
Jakarta, Jakarta Pusat, Indonesia, 10430
- Recruiting
- Cipto Mangunkusumo Hospital
-
Contact:
- Dwirini Retno Gunarti, Dr drg Master of Science
- Phone Number: 08118382301
- Email: drg.yellow@gmail.com
-
Principal Investigator:
- Eka Rusdianto Gunardi, Dr dr SpOG(K)-FER
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 20-49 years and already menstruating with complaints of menstrual pain referred to the obstetrics and gynecology polyclinic for LNG implant placement
- Willing to have LNG implant installed after receiving explanation about implants
- Not receiving hormonal treatment for endometriosis within the last 3 months
- Can receive drops (propolis) during the study
Exclusion Criteria:
- Impaired liver function, degenerative diseases (DM, hypertension and cardiovascular disease), benign tumors, cancer
- Pregnancy and breastfeeding
- Hypersensitivity to levonogestrel
- Thromboembolic disease
- Experiencing bleeding for unknown reasons
- History of allergies to honey and its processed products
- Currently taking supplements/drugs that are not included in the standard management of endometriosis patients at RSCM
- Have consumed propolis before
- Received hormonal treatment within the last 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Propolis
the subjects were asked to consume propolis 1 drop/10 kgbw/time given 2 times a day for 12 weeks.
the dose will be calculated based on body weight by the certified nutritionist during the interview after the subject signs the informed consent form
|
intervention will use propolis extract (liquid-based) with 1 drop/10kgBW/times, 2 times in a day for 12 weeks.
propolis will be given to intervention group
|
Placebo Comparator: Placebo
the subjects were asked to consume placebo (glucose-only contained) 1 drop/10 kgbw/time given 2 times a day for 12 weeks.
the dose will be calculated based on body weight by the certified nutritionist during the interview after the subject signs the informed consent form
|
intervention will use placebo with 1 drop/10kgBW/times, 2 times in a day for 12 weeks.
propolis will be given control group
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Malondialdehyde (MDA)
Time Frame: week 0
|
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
|
week 0
|
Malondialdehyde (MDA)
Time Frame: week 4
|
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
|
week 4
|
Malondialdehyde (MDA)
Time Frame: week 12
|
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
|
week 12
|
Superoxide dismutase (SOD)
Time Frame: week 0
|
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
|
week 0
|
Superoxide dismutase (SOD)
Time Frame: week 4
|
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
|
week 4
|
Superoxide dismutase (SOD)
Time Frame: week 12
|
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
|
week 12
|
interleukin 6
Time Frame: week 0
|
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
|
week 0
|
interleukin 6
Time Frame: week 4
|
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
|
week 4
|
interleukin 6
Time Frame: week 12
|
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
|
week 12
|
tumor necrosis factor alpha (TNF alfa)
Time Frame: week 0
|
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
|
week 0
|
tumor necrosis factor alpha (TNF alfa)
Time Frame: week 4
|
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
|
week 4
|
tumor necrosis factor alpha (TNF alfa)
Time Frame: week 12
|
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
|
week 12
|
Glutathione
Time Frame: week 0
|
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
|
week 0
|
Glutathione
Time Frame: week 4
|
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
|
week 4
|
Glutathione
Time Frame: week 12
|
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
|
week 12
|
8-hydroxy-2-deoxyiguanosine (8-OHdG)
Time Frame: week 0
|
measure the outcome with ELISA from blood sample in ng/mL numeric scale
|
week 0
|
8-hydroxy-2-deoxyiguanosine (8-OHdG)
Time Frame: week 4
|
measure the outcome with ELISA from blood sample in ng/mL numeric scale
|
week 4
|
8-hydroxy-2-deoxyiguanosine (8-OHdG)
Time Frame: week 12
|
measure the outcome with ELISA from blood sample in ng/mL numeric scale
|
week 12
|
pain scale
Time Frame: week 0
|
to measure the outcome, the investigators use Visual Analogue Scale for measure the pain from the subject, from 0 to 10.
The scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
the subject will be asked to rate their current level of pain by placing a mark on the line.
|
week 0
|
pain scale
Time Frame: week 4
|
to measure the outcome, the investigators use Visual Analogue Scale for measure the pain from the subject, from 0 to 10.
The scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
the subject will be asked to rate their current level of pain by placing a mark on the line.
|
week 4
|
pain scale
Time Frame: week 12
|
to measure the outcome, the investigators use Visual Analogue Scale for measure the pain from the subject, from 0 to 10.
The scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
the subject will be asked to rate their current level of pain by placing a mark on the line.
|
week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dwirini Retno Gunarti, Dr drg Master of Science
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KET-683/UN2.F1/ETIK/PPM.00.02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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