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

Endometriosis Clinical Trial

Official title:

Effect of Propolis Administration as Levonorgestrel (LNG) Implant Adjuvant for Dysmenorrhea in Endometriosis: Focus on Clinical Improvement, Oxidative Stress Biomarkers and Inflammation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05770297
• Other study ID #: KET-683/UN2.F1/ETIK/PPM.00.02
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: July 11, 2023

Study information

• Verified date: June 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 11, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Endometriosis

Intervention

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

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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta	Jakarta Pusat

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

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