Effect of Propolis Administration as Levonorgestrel (LNG) Implant Adjuvant for Dysmenorrhea in Endometriosis: Focus on Clinical Improvement, Oxidative Stress Biomarkers and Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Malondialdehyde (MDA)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
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
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Malondialdehyde (MDA)
时间窗: week 12
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using ng/mL numeric scale
tumor necrosis factor alpha (TNF alfa)
时间窗: week 12
will test the outcome with ELISA test for inflammatory biomarker, using ng/mL numeric scale
Glutathione
时间窗: week 12
measure the outcome with blood biochemical test using spectrofotometri in µg/mL numeric scale
8-hydroxy-2-deoxyiguanosine (8-OHdG)
时间窗: week 12
measure the outcome with ELISA from blood sample in ng/mL numeric scale
interleukin 6
时间窗: week 12
will test the outcome with ELISA test from blood sample for inflammatory biomarker, using ng/mL numeric scale
Superoxide dismutase (SOD)
时间窗: week 12
blood biochemical test for oxidative stress biomarker from lipid peroxidation product, using nmol/mLnumeric scale
pain scale
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. drg. Dwirini Retno Gunarti, M.S.
Head of Biochemistry Laboratory
Indonesia University