Effect of Propolis Administration for Dysmenorrhea in Endometriosis Patient With Levonorgestrel Implant Therapy

Not Applicable

Recruiting

• Conditions: Dysmenorrhea; Endometriosis

• 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

Study Timeline

• Study Start: 2022-07-12
• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-06
• Primary Completion: 2023-06-22
• Study Completion: 2023-07-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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.
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

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta, Jakarta Pusat, Indonesia