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Completed

NCT Number: NCT04374006

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

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

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Key information

Conditions

Endometriosis; Peritoneum Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Animal Laboratory of Indonesia University

Jakarta, Capital Special Region, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female ratus rat type
  • having normal estrus cycle

Exclusion criteria

  • nothing

Treatment and study plan

Dienogest

Drug

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

Other names: visanne

Propolis

Drug

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

Other names: sulawesian propolis

Placebo

Other

we gave 0,2 ml to each rat everyday to negative control groups, and we gave no treatment to sham groups

Primary outcomes

  1. mRNA expressions of Bax, Bcl, Cleaved Caspase 3, IL-1B, and PGE 2

    Time frame: through study completion, an average of 6 months

    The expression of Bax, Bcl-2, ad Caspase 3, IL-1B, PGE2 mRNA was carried out by isolating the RNA samples of endometriosis tissue based on the modified QIAamp RNA Blod Mini Handbook protocol. RNA spectrophotometric measurments and cDNA synthesis were carried out based on the Instruction Manual ReverTra Ace qPCR RT Master Mix with gDNA Remover protocol (Toyobo 2017: 2). In real-time PCR examination, the melting temperature (Tm) was determined to perform Quantitative Real-time PCR (Q-PCR) based on the QuantiTech SYBR Green PCR Handbook protocol (Qiagen 2011: 11) using a 3-step cycling cycle. The results were then compared with the standard curve and analyzed

  2. Mollecular docking

    Time frame: during the procedure

    Twenty-three compounds contained in Propolis were tested by screening using rule of 5 (Lipinski's rule), screening results determine which compounds can enter the body and can work in endometriosis tissue. Furthermore, the three-dimensional shape is made of compounds which have passed the first stage. This process was created using the Marvin Sketch program. Furthermore, the compound that has been formed is stored as a ligand with extension pdb (protein data bank). Look for NFĸB receptor proteins, estrogen A, estrogen B, progesterone A and progesterone B in the protein data bank, which will be stored as protein. Ligands and proteins are tested using standard Lamarckian algorithms in the Autodock program. The results obtained are in the form of bond energy (ΔG), where smaller results indicate a higher likelihood of interaction

  3. Lession size

    Time frame: during the procedure

    In the second laparotomy (before the treatment are given) the investigators take a picture of the lession (as the beginning lession). Then the investigators give the treatment. After the treatment are done, the investigators do the necropsy to take a picture after the treatment was given to compare it with the beginning

  4. The normality of estrus cycle after the treatment

    Time frame: during the procedure

    Vaginal discharge of the rat obtained through vaginal lavage was fixed using 90% alcohol solution and stained using Giemsa. The specimen was examined microscopically to determined its estrous cycle

Secondary outcomes

  1. Organs morpholgy after the treatment

    Time frame: through study completion, an average of 6 months

    In the necropsy, the investigators take ovarium, uterus, and peritonium to see if there's any change in morphology after the treatment was given

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Effects of Tetragonula Aff. Biroi Propolis Extract on Lesion Growth, Apoptotic and Inflammatory Activity of the Rat Endometriosis Tissue

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 5, 2020
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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