Clinical trial NCT04374006: Effects of Sulawesi Propolis Extract on Lesion Growth, Apoptotic and Inflammatory Activity of the Rat Endometriosis Tissue
Official title: Effects of Tetragonula Aff. Biroi Propolis Extract on Lesion Growth, Apoptotic and Inflammatory Activity of the Rat Endometriosis Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Endometriosis; Peritoneum
Endometriosis
Keywords: endometriosis
propolis
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluating inflammatory and apoptotic activity in rat's endometriosis lesion treated by Propolis compared to Dienogest

Detailed description: Propolis has known of having various efficacy. The main benefits are as antimicrobial, antioxidant, anti-inflammatory, immunomodulatory and antiapoptotic.Propolis has even been shown to have an antibacterial effect in vitro, without requiring human immunological reactions.

The immunological effect of propolis is generated through immune suppression directly and decreasing cytokine production which stimulates immune process. Although proven to have a various efficacy, propolis can't be used as a therapeutic drug due to the difficulty of obtaining standard chemical composition as a requirement to be the drug's substances. Therefore, it is necessary to have biological composition in each propolis prepartions written down before comparing the efficacy.

Anti tumor activity by propolis, which has been tested in animal previously, showed that propolis can inhibit DNA synthesis in tumor cells, induce cell apoptosis and activate macrophage to produce factors which regulate the function of B, T, as well as NK cell.

Dienogest, is the next choice of progestin drug class. It has high selectivity binding in progesterone receptors, inhibits cytokine secretion in endometriosis stroma cell and induces apoptosis in endometriosis cell. Dienogest also has slight inhibitory effect against estradiol, so it can deminisce the symptoms due to hypoestrogenic such as decresing in bone mass density.

Eligibility criteria: Inclusion Criteria:

* female ratus rat type
* having normal estrus cycle

Exclusion Criteria:

* nothing

Primary outcomes:
measure: mRNA expressions of Bax, Bcl, Cleaved Caspase 3, IL-1B, and PGE 2
timeFrame: through study completion, an average of 6 months
measure: Mollecular docking
timeFrame: during the procedure
measure: Lession size
timeFrame: during the procedure
measure: The normality of estrus cycle after the treatment
timeFrame: during the procedure
Secondary outcomes:
measure: Organs morpholgy after the treatment
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Animal Laboratory of Indonesia University
state: Capital Special Region
Study officials:
affiliation: Lecturer at Obgyn Department, Indonesia University
name: Wachyu Hadisaputra, Prof, dr, SpOG
role: PRINCIPAL_INVESTIGATOR
References: