Effects of Sulawesi Propolis Extract on Lesion Growth, Apoptotic and Inflammatory Activity of the Rat Endometriosis Tissue

University of Indonesia (UI)

Status and phase: Completed; Early Phase 1

Conditions: Endometriosis; Endometriosis; Peritoneum

Treatments: Other: placebo; Drug: Propolis; Drug: Dienogest

Study type: Interventional

Funder types: Other

Identifiers

NCT04374006

19-10-1269'

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• female ratus rat type
• having normal estrus cycle

Exclusion criteria

• nothing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 5 patient groups, including a placebo group

propolis 50

Experimental group

Description:

we do sonde everyday to the rat that given treatment of 50mg/kg propolis for 2, 4, and 6 weeks

Treatment:

Drug: Propolis

propolis 100

Experimental group

Description:

we do sonde everyday to the rat that given treatment of 100mg/kg propolis for 2, 4, and 6 weeks

Treatment:

Drug: Propolis

dienogest

Active Comparator group

Description:

we do sonde everyday to the rat that given treatment of 25mg/kg dienogest for 2, 4, and 6 weeks

Treatment:

Drug: Dienogest

water

Placebo Comparator group

Description:

we do sonde everyday to the rat that given 0,2 ml water placebo for 2, 4, and 6 weeks

Treatment:

Other: placebo

sham group

Sham Comparator group

Description:

after the 2nd laparotomy, we do nothing about sonde, just giving food and drink everyday

Treatment:

Other: placebo