Clinical trial NCT05770297: Effect of Propolis Administration for Dysmenorrhea in Endometriosis Patient With Levonorgestrel Implant Therapy
Official title: Effect of Propolis Administration as Levonorgestrel (LNG) Implant Adjuvant for Dysmenorrhea in Endometriosis: Focus on Clinical Improvement, Oxidative Stress Biomarkers and Inflammation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Dysmenorrhea
Keywords: Levonorgestrel implant
Propolis
Oxidative stress
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 24
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Malondialdehyde (MDA)
timeFrame: week 0
measure: Malondialdehyde (MDA)
timeFrame: week 4
measure: Malondialdehyde (MDA)
timeFrame: week 12
measure: Superoxide dismutase (SOD)
timeFrame: week 0
measure: Superoxide dismutase (SOD)
timeFrame: week 4
measure: Superoxide dismutase (SOD)
timeFrame: week 12
measure: interleukin 6
timeFrame: week 0
measure: interleukin 6
timeFrame: week 4
measure: interleukin 6
timeFrame: week 12
measure: tumor necrosis factor alpha (TNF alfa)
timeFrame: week 0
measure: tumor necrosis factor alpha (TNF alfa)
timeFrame: week 4
measure: tumor necrosis factor alpha (TNF alfa)
timeFrame: week 12
measure: pain scale
timeFrame: week 0
measure: pain scale
timeFrame: week 4
measure: pain scale
timeFrame: week 12
measure: Glutathione
timeFrame: week 0
measure: Glutathione
timeFrame: week 4
measure: Glutathione
timeFrame: week 12
measure: 8-hydroxy-2-deoxyiguanosine (8-OHdG)
timeFrame: week 0
measure: 8-hydroxy-2-deoxyiguanosine (8-OHdG)
timeFrame: week 4
measure: 8-hydroxy-2-deoxyiguanosine (8-OHdG)
timeFrame: week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: Jakarta Pusat
Study officials:
name: Dwirini Retno Gunarti, Dr drg Master of Science
role: PRINCIPAL_INVESTIGATOR
References: