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

NCT05770297 | Unknown DMC

• 1 other identifier: KET-683/UN2.F1/ETIK/PPM.00.02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Dysmenorrhea

Keywords

Levonorgestrel implant; Propolis; Oxidative stress

Outcome Measures

Primary Outcomes (21)

• 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, 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

• 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

• 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

• 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

Study Arms (2)

Propolis

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Propolis DIETARY_SUPPLEMENT

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

Propolis

placebo OTHER

intervention will use placebo with 1 drop/10kgBW/times, 2 times in a day for 12 weeks. propolis will be given control group

Also known as: 70% caramel alcohol dye solution

Placebo

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, Jakarta Pusat, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Endometriosis; Dysmenorrhea

Interventions

Propolis; caramel coloring; Ethanol

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures; Alcohols; Organic Chemicals

Study Officials

• Dwirini Retno Gunarti, Dr drg Master of Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: there will be a comparison group that will receive intervention in the same amount, preparation, and form, but only contain a placebo in the form of a 70% caramel alcohol dye solution. Investigator and participant will not know the contain of intervention that has given. Randomization of participants was carried out based on the arrival of participants to the obstetrics and gynecology clinic at the Cipto Mangunkusumo Hospital by labeling A for the intervention group and B for the treatment group. then data collection is carried out according to research procedures
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Biochemistry Laboratory

Model Details: Endometriosis patients with menstrual pain who received LNG implant therapy were divided into two groups, each group consisted of 12 samples. The control group only received LNG, the treatment group received LNG with the addition of propolis. Propolis is given 2 times a day, namely in the morning before breakfast and at night before going to bed, with a dose of 1 drop /10 kg body weight (kgBW). Both groups were followed and reassessed after 1 month, 3 months both clinical and laboratory. Prior to receiving therapy, all subjects received education and signed informed consent for their willingness to participate in the study

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: March 15, 2023
• Study Start: July 12, 2022
• Primary Completion: June 22, 2023
• Study Completion: July 11, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)