Dysmenorrhea, Endometriosis
Conditions
Keywords
Levonorgestrel implant, Propolis, Oxidative stress
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.
Interventions
DIETARY_SUPPLEMENTPropolis
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
OTHERplacebo
intervention will use placebo with 1 drop/10kgBW/times, 2 times in a day for 12 weeks. propolis will be given control group
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, 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
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 study
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 49 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malondialdehyde (MDA) | week 0 | 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 |
| interleukin 6 | week 0 | 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 |
| pain scale | 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. |
| Glutathione | week 0 | 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 |
Countries
Indonesia
Outcome results
None listed