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

Last updated: June 5, 2023
Sponsor: Indonesia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Severe Premenstrual Symptom

Female Hormonal Deficiencies/abnormalities

Endometriosis

Treatment

Propolis

placebo

Clinical Study ID

NCT05770297
KET-683/UN2.F1/ETIK/PPM.00.02
  • Ages 20-49
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged 20-49 years and already menstruating with complaints of menstrual painreferred 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

Exclusion Criteria:

  • Impaired liver function, degenerative diseases (DM, hypertension and cardiovasculardisease), 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 ofendometriosis patients at RSCM
  • Have consumed propolis before
  • Received hormonal treatment within the last 3 months

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Propolis
Phase:
Study Start date:
July 12, 2022
Estimated Completion Date:
July 11, 2023

Connect with a study center

  • Cipto Mangunkusumo Hospital

    Jakarta, Jakarta Pusat 10430
    Indonesia

    Active - Recruiting

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