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: Recruiting
• Conditions: Endometriosis; Dysmenorrhea
• Intervention / Treatment: Dietary supplement: Propolis; Other: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta Pusat
    • Jakarta, Jakarta Pusat, Indonesia, 10430
      • Recruiting
      • Cipto Mangunkusumo Hospital
      • Contact: Dwirini Retno Gunarti, Dr drg Master of Science; Phone Number: 08118382301; Email: [email protected]
      • Principal Investigator: Eka Rusdianto Gunardi, Dr dr SpOG(K)-FER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

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

Number of Arms

2

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	Dietary supplement: Propolis; 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	Other: placebo; 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: 70% caramel alcohol dye solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malondialdehyde (MDA)	blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale	week 0
Malondialdehyde (MDA)	blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale	week 4
Malondialdehyde (MDA)	blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale	week 12
Superoxide dismutase (SOD)	blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale	week 0
Superoxide dismutase (SOD)	blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale	week 4
Superoxide dismutase (SOD)	blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale	week 12
interleukin 6	will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale	week 0
interleukin 6	will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale	week 4
interleukin 6	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)	will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale	week 0
tumor necrosis factor alpha (TNF alfa)	will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale	week 4
tumor necrosis factor alpha (TNF alfa)	will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale	week 12
pain scale	to measure the outcome, we 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	to measure the outcome, we 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	to measure the outcome, we 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
Glutathione	measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale	week 0
Glutathione	measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale	week 4
Glutathione	measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale	week 12
8-hydroxy-2-deoxyiguanosine (8-OHdG)	measure the outcome with ELISA from blood sample in ng/mL numeric scale	week 0
8-hydroxy-2-deoxyiguanosine (8-OHdG)	measure the outcome with ELISA from blood sample in ng/mL numeric scale	week 4
8-hydroxy-2-deoxyiguanosine (8-OHdG)	measure the outcome with ELISA from blood sample in ng/mL numeric scale	week 12

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Dwirini Retno Gunarti, Dr drg Master of Science

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Anticipated): April 22, 2023
• Study Completion (Anticipated): July 11, 2023

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Oxidative stress; Propolis; Levonorgestrel implant
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Endometriosis; Dysmenorrhea; Anti-Infective Agents; Propolis
• 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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No