An interventional study of Propolis and placebo in Endometriosis and Dysmenorrhea, sponsored by Indonesia University. Recruiting at 1 site in Indonesia. Open to female participants aged 20 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-06.
Sponsored by Indonesia University · Not applicable, Interventional, and Supportive care
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.
902 studies on the registry are indexed under Endometriosis; 260 are open to participants now.
This study's planned enrollment of 24 is below the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 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 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
Malondialdehyde (MDA)
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
Time frame: week 0
Malondialdehyde (MDA)
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
Time frame: week 4
Malondialdehyde (MDA)
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
Time frame: week 12
Superoxide dismutase (SOD)
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
Time frame: week 0
Superoxide dismutase (SOD)
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
Time frame: week 4
Superoxide dismutase (SOD)
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
Time frame: week 12
interleukin 6
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
Time frame: week 0
interleukin 6
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
Time frame: week 4
interleukin 6
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
Time frame: week 12
tumor necrosis factor alpha (TNF alfa)
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
Time frame: week 0
tumor necrosis factor alpha (TNF alfa)
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
Time frame: week 4
tumor necrosis factor alpha (TNF alfa)
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 12
Glutathione
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
Time frame: week 0
Glutathione
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
Time frame: week 4
Glutathione
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
Time frame: week 12
8-hydroxy-2-deoxyiguanosine (8-OHdG)
measure the outcome with ELISA from blood sample in ng/mL numeric scale
Time frame: week 0
8-hydroxy-2-deoxyiguanosine (8-OHdG)
measure the outcome with ELISA from blood sample in ng/mL numeric scale
Time frame: week 4
8-hydroxy-2-deoxyiguanosine (8-OHdG)
measure the outcome with ELISA from blood sample in ng/mL numeric scale
Time frame: week 12
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Indonesia University