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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dwirini Retno Gunarti, Dr drg Master of Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Hospital | Recruiting | Jakarta | Jakarta Pusat | 10430 | Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Feb 17, 2022 | Mar 24, 2023 | Prot_ICF_001.pdf |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011429 | Propolis |
| C569050 | caramel coloring |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D012116 | Resins, Plant |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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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
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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
| 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 |
|
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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 |
| D000091662 | Genital Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D053147 |
| Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |