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

University of Indonesia (UI)

Status: Enrolling

Conditions: Dysmenorrhea; Endometriosis

Treatments: Dietary Supplement: Propolis; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05770297

KET-683/UN2.F1/ETIK/PPM.00.02

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 20 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Propolis

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Propolis

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo