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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04374006
Recruitment Status : Active, not recruiting
First Posted : May 5, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
dr Herbert Situmorang,SpOG(K), Indonesia University

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

Condition or disease Intervention/treatment Phase
Endometriosis; Peritoneum Endometriosis Drug: Dienogest Drug: Propolis Other: placebo Early Phase 1

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.

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Study Type : Interventional
Estimated Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Tetragonula Aff. Biroi Propolis Extract on Lesion Growth, Apoptotic and Inflammatory Activity of the Rat Endometriosis Tissue
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: propolis 50
we do sonde everyday to the rat that given treatment of 50mg/kg propolis for 2, 4, and 6 weeks
Drug: Propolis
The propolis contains xx mg in each ml. So, each rat we give 0,2 ml for 50mg/kg propolis treatment and 0,4 ml for 100mg/kg propolis treatment
Other Name: sulawesian propolis

Experimental: propolis 100
we do sonde everyday to the rat that given treatment of 100mg/kg propolis for 2, 4, and 6 weeks
Drug: Propolis
The propolis contains xx mg in each ml. So, each rat we give 0,2 ml for 50mg/kg propolis treatment and 0,4 ml for 100mg/kg propolis treatment
Other Name: sulawesian propolis

Active Comparator: dienogest
we do sonde everyday to the rat that given treatment of 25mg/kg dienogest for 2, 4, and 6 weeks
Drug: Dienogest
We divide the pil into 1,75 mg then it is destructed into powder and adding 1 ml water. The dosage is for 5 rats
Other Name: visanne

Placebo Comparator: water
we do sonde everyday to the rat that given 0,2 ml water placebo for 2, 4, and 6 weeks
Other: placebo
there's nothing we do for sham group. On the other hand, we give 0,2 ml everyday to the water treatment group

Sham Comparator: sham group
after the 2nd laparotomy, we do nothing about sonde, just giving food and drink everyday
Other: placebo
there's nothing we do for sham group. On the other hand, we give 0,2 ml everyday to the water treatment group




Primary Outcome Measures :
  1. Protein Levels of Bax, Bcl, Cleaved Caspase 3, IL-1B, and PGE 2 [ Time Frame: through study completion, an average of 6 months ]
    Protein samples were obtained from endometriosis tissue taken by the treatment group. The lysis network uses a lysis buffer solution at 4 ° C for 30 minutes. The total protein is then broken down based on its molecular weight by the SDS-PAGE (Sodium Docecyl Sulphate-Polycramide Gel Electrophoresis) method and transferred to the PVDF (Polyvinylidene Difluoride) membrane. The membrane is then incubated with primary antibodies (Anti-Bax antibody [Abcam], Anti-Bcl-2 antibody [Abcam], Anti-Cleaved Caspase-3 antibody [Abcam], Anti-IL-1B antibody [Abcam]), followed by incubation with secondary antibodies (Horse-Radish Peroxidase [Santa Cruz Biotechnology]). Proteins that have been bound to antibodies are then viewed using enhanced chemiluminescent reagent kits [Boster Bio]

  2. Mollecular docking [ Time Frame: during the procedure ]
    Twenty-three compounds contained in Propolis were tested by screening using rule 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 ]
    A week before the necropsy, the investigators do the vaginal swab to see if the rat still have the normal cycle after the treatment was given


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   we used female rats to make a model of endometriosis
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female ratus rat type
  • having normal estrus cycle

Exclusion Criteria:

  • nothing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374006


Locations
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Indonesia
Animal Laboratory of Indonesia University
Jakarta, Capital Special Region, Indonesia
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Wachyu Hadisaputra, Prof, dr, SpOG Lecturer at Obgyn Department, Indonesia University
  Study Documents (Full-Text)

Documents provided by dr Herbert Situmorang,SpOG(K), Indonesia University:
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Responsible Party: dr Herbert Situmorang,SpOG(K), Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT04374006    
Other Study ID Numbers: 19-10-1269'
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by dr Herbert Situmorang,SpOG(K), Indonesia University:
endometriosis
propolis
Additional relevant MeSH terms:
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Endometriosis
Propolis
Dienogest
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Infective Agents