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

Primary Purpose

Endometriosis, Dysmenorrhea

Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Propolis
placebo
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Endometriosis focused on measuring Levonorgestrel implant, Propolis, Oxidative stress

Eligibility Criteria

20 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cipto Mangunkusumo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Propolis

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 24, 2023
Last Updated
June 5, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05770297
Brief Title
Effect of Propolis Administration for Dysmenorrhea in Endometriosis Patient With Levonorgestrel Implant Therapy
Official Title
Effect of Propolis Administration as Levonorgestrel (LNG) Implant Adjuvant for Dysmenorrhea in Endometriosis: Focus on Clinical Improvement, Oxidative Stress Biomarkers and Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
June 22, 2023 (Anticipated)
Study Completion Date
July 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Dysmenorrhea
Keywords
Levonorgestrel implant, Propolis, Oxidative stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 study
Masking
ParticipantInvestigator
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
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propolis
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Propolis
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
70% caramel alcohol dye solution
Intervention Description
intervention will use placebo with 1 drop/10kgBW/times, 2 times in a day for 12 weeks. propolis will be given control group
Primary Outcome Measure Information:
Title
Malondialdehyde (MDA)
Description
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
Time Frame
week 0
Title
Malondialdehyde (MDA)
Description
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
Time Frame
week 4
Title
Malondialdehyde (MDA)
Description
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
Time Frame
week 12
Title
Superoxide dismutase (SOD)
Description
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
Time Frame
week 0
Title
Superoxide dismutase (SOD)
Description
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
Time Frame
week 4
Title
Superoxide dismutase (SOD)
Description
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
Time Frame
week 12
Title
interleukin 6
Description
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
Time Frame
week 0
Title
interleukin 6
Description
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
Time Frame
week 4
Title
interleukin 6
Description
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
Time Frame
week 12
Title
tumor necrosis factor alpha (TNF alfa)
Description
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
Time Frame
week 0
Title
tumor necrosis factor alpha (TNF alfa)
Description
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
Time Frame
week 4
Title
tumor necrosis factor alpha (TNF alfa)
Description
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
Time Frame
week 12
Title
pain scale
Description
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.
Time Frame
week 0
Title
pain scale
Description
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.
Time Frame
week 4
Title
pain scale
Description
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.
Time Frame
week 12
Title
Glutathione
Description
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
Time Frame
week 0
Title
Glutathione
Description
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
Time Frame
week 4
Title
Glutathione
Description
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
Time Frame
week 12
Title
8-hydroxy-2-deoxyiguanosine (8-OHdG)
Description
measure the outcome with ELISA from blood sample in ng/mL numeric scale
Time Frame
week 0
Title
8-hydroxy-2-deoxyiguanosine (8-OHdG)
Description
measure the outcome with ELISA from blood sample in ng/mL numeric scale
Time Frame
week 4
Title
8-hydroxy-2-deoxyiguanosine (8-OHdG)
Description
measure the outcome with ELISA from blood sample in ng/mL numeric scale
Time Frame
week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dwirini Retno Gunarti, Dr drg Master of Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta
State/Province
Jakarta Pusat
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dwirini Retno Gunarti, Dr drg Master of Science
Phone
08118382301
Email
drg.yellow@gmail.com
First Name & Middle Initial & Last Name & Degree
Eka Rusdianto Gunardi, Dr dr SpOG(K)-FER

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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