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

Sponsor

Indonesia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05770297

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis Dysmenorrhea	Dietary Supplement: Propolis Other: placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 studyEndometriosis 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

Masking:

Double (Participant, Investigator)

Masking Description:

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

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 12, 2022

Anticipated Primary Completion Date :

Apr 22, 2023

Anticipated Study Completion Date :

Jul 11, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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