Effects of Sulawesi Propolis Extract on Lesion Growth, Apoptotic and Inflammatory Activity of the Rat Endometriosis Tissue
NCT ID: NCT04374006
Last Updated: 2021-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
120 participants
INTERVENTIONAL
2019-11-01
2020-05-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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propolis 50
we do sonde everyday to the rat that given treatment of 50mg/kg propolis for 2, 4, and 6 weeks
Propolis
The propolis contains 20 mg in each ml. So, each rat we given 0,2 ml for 50mg/kg propolis treatment and 0,4 ml for 100mg/kg propolis treatment
propolis 100
we do sonde everyday to the rat that given treatment of 100mg/kg propolis for 2, 4, and 6 weeks
Propolis
The propolis contains 20 mg in each ml. So, each rat we given 0,2 ml for 50mg/kg propolis treatment and 0,4 ml for 100mg/kg propolis treatment
dienogest
we do sonde everyday to the rat that given treatment of 25mg/kg dienogest for 2, 4, and 6 weeks
Dienogest
1mg/kg BW/day based on the study by Katayama et al. A DNG in 0,5% carboxymethylcellulose suspension was given orally with metal sound daily 0,2-0,4 mL per day
water
we do sonde everyday to the rat that given 0,2 ml water placebo for 2, 4, and 6 weeks
placebo
we gave 0,2 ml to each rat everyday to negative control groups, and we gave no treatment to sham groups
sham group
after the 2nd laparotomy, we do nothing about sonde, just giving food and drink everyday
placebo
we gave 0,2 ml to each rat everyday to negative control groups, and we gave no treatment to sham groups
Interventions
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Dienogest
1mg/kg BW/day based on the study by Katayama et al. A DNG in 0,5% carboxymethylcellulose suspension was given orally with metal sound daily 0,2-0,4 mL per day
Propolis
The propolis contains 20 mg in each ml. So, each rat we given 0,2 ml for 50mg/kg propolis treatment and 0,4 ml for 100mg/kg propolis treatment
placebo
we gave 0,2 ml to each rat everyday to negative control groups, and we gave no treatment to sham groups
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* having normal estrus cycle
Exclusion Criteria
FEMALE
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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dr Herbert Situmorang,SpOG(K)
Principal Investigator
Principal Investigators
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Wachyu Hadisaputra, Prof, dr, SpOG
Role: PRINCIPAL_INVESTIGATOR
Lecturer at Obgyn Department, Indonesia University
Locations
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Animal Laboratory of Indonesia University
Jakarta, Capital Special Region, Indonesia
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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19-10-1269'
Identifier Type: -
Identifier Source: org_study_id
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