Effect of Propolis Administration for Dysmenorrhea in Endometriosis Patient With Levonorgestrel Implant Therapy
- Conditions
- DysmenorrheaEndometriosis
- Interventions
- Other: placeboDietary Supplement: Propolis
- Registration Number
- NCT05770297
- Lead Sponsor
- Indonesia University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 24
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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 Propolis 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
- Primary Outcome Measures
Name Time Method Malondialdehyde (MDA) week 12 blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
tumor necrosis factor alpha (TNF alfa) week 12 will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
Glutathione week 12 measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
8-hydroxy-2-deoxyiguanosine (8-OHdG) week 12 measure the outcome with ELISA from blood sample in ng/mL numeric scale
interleukin 6 week 12 will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
Superoxide dismutase (SOD) week 12 blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
pain scale 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cipto Mangunkusumo Hospital
🇮🇩Jakarta, Jakarta Pusat, Indonesia