EndometriosisNCT05770297
Effect of Propolis Administration for Dysmenorrhea in Endometriosis Patient With Levonorgestrel Implant Therapy
A study testing Propolis in people with Endometriosis and Dysmenorrhea, run by Universitas Indonesia at 1 site in Indonesia.
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… Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Dysmenorrhea
- What is being tested?
- Propolis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Jul 2022to 11 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo Hospital
Jakarta, Jakarta Pusat, 10430
Dwirini Retno Gunarti, Dr drg Master of Science, 08118382301, drg.yellow@gmail.com
Eka Rusdianto Gunardi, Dr dr SpOG(K)-FER
About this study
Official title: 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.
- Conditions
- Endometriosis, Dysmenorrhea
- Being tested
- Propolis, placebo
- Keywords
- Levonorgestrel implant, Propolis, Oxidative stress
- Medical subject headings
- Endometriosis, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropolisDietary 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
placeboOther
Also called 70% caramel alcohol dye solution
intervention will use placebo with 1 drop/10kgBW/times, 2 times in a day for 12 weeks. propolis will be given control group
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malondialdehyde (MDA)
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
Measured: week 0
Malondialdehyde (MDA)
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
Measured: week 4
Malondialdehyde (MDA)
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
Measured: week 12
Superoxide dismutase (SOD)
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
Measured: week 0
Superoxide dismutase (SOD)
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
Measured: week 4
Superoxide dismutase (SOD)
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
Measured: week 12
interleukin 6
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
Measured: week 0
interleukin 6
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
Measured: week 4
interleukin 6
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
Measured: week 12
tumor necrosis factor alpha (TNF alfa)
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
Measured: week 0
tumor necrosis factor alpha (TNF alfa)
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
Measured: week 4
tumor necrosis factor alpha (TNF alfa)
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 12
Glutathione
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
Measured: week 0
Glutathione
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
Measured: week 4
Glutathione
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
Measured: week 12
8-hydroxy-2-deoxyiguanosine (8-OHdG)
measure the outcome with ELISA from blood sample in ng/mL numeric scale
Measured: week 0
8-hydroxy-2-deoxyiguanosine (8-OHdG)
measure the outcome with ELISA from blood sample in ng/mL numeric scale
Measured: week 4
8-hydroxy-2-deoxyiguanosine (8-OHdG)
measure the outcome with ELISA from blood sample in ng/mL numeric scale
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start12 Jul 2022
- Primary completion22 Jun 2023 (estimated)
- Study completion11 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. drg. Dwirini Retno Gunarti, M.S., Universitas Indonesia
- Investigators
- Dwirini Retno Gunarti, Dr drg Master of Science, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770297
- Sponsor's protocol ID
- KET-683/UN2.F1/ETIK/PPM.00.02
- Status last verified
- Jun 2023
- First submitted
- 24 Jan 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propolis Administration as Levonorgestrel (LNG) Implant Adjuvant for Dysmenorrhea in Endometriosis: Focus on Clinical Improvement, Oxidative Stress Biomarkers and Inflammation
- ClinicalTrials.gov ID
- NCT05770297
- Acronym / sponsor ID
- KET-683/UN2.F1/ETIK/PPM.00.02
- Conditions
- Endometriosis, Dysmenorrhea
- Keywords
- Levonorgestrel implant, Propolis, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 22 Jun 2023 (estimated)
- Study completion
- 11 Jul 2023 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Propolis | Active comparator | Dietary Supplement: Propolisthe 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 |
| Placebo | Placebo comparator | Other: placebothe 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 |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propolisintervention 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 | Dietary supplement | Propolis |
| placeboAlso: 70% caramel alcohol dye solutionintervention will use placebo with 1 drop/10kgBW/times, 2 times in a day for 12 weeks. propolis will be given control group | Other | Placebo |
Primary outcome
Malondialdehyde (MDA)
Time frame: week 0
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
Malondialdehyde (MDA)
Time frame: week 4
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
Malondialdehyde (MDA)
Time frame: week 12
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
Superoxide dismutase (SOD)
Time frame: week 0
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
Superoxide dismutase (SOD)
Time frame: week 4
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
Superoxide dismutase (SOD)
Time frame: week 12
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
interleukin 6
Time frame: week 0
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
interleukin 6
Time frame: week 4
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
interleukin 6
Time frame: 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)
Time frame: week 0
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
tumor necrosis factor alpha (TNF alfa)
Time frame: week 4
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
tumor necrosis factor alpha (TNF alfa)
Time frame: week 12
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
pain scale
Time frame: week 0
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
Time frame: week 4
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
Time frame: week 12
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
Time frame: week 0
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
Glutathione
Time frame: week 4
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
Glutathione
Time frame: week 12
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
8-hydroxy-2-deoxyiguanosine (8-OHdG)
Time frame: week 0
measure the outcome with ELISA from blood sample in ng/mL numeric scale
8-hydroxy-2-deoxyiguanosine (8-OHdG)
Time frame: week 4
measure the outcome with ELISA from blood sample in ng/mL numeric scale
8-hydroxy-2-deoxyiguanosine (8-OHdG)
Time frame: week 12
measure the outcome with ELISA from blood sample in ng/mL numeric scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dwirini Retno Gunarti, Dr drg Master of Science principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propolis in people with Endometriosis and Dysmenorrhea, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malondialdehyde (MDA) (time frame: week 0). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.