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

NCT04374006 | Completed Early Phase 1

• 1 other identifier: 19-10-1269'
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometriosis; Peritoneum; Endometriosis

Keywords

endometriosis; propolis

Outcome Measures

Primary Outcomes (4)

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

  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

  through study completion, an average of 6 months

• Mollecular docking

  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

  during the procedure

• Lession size

  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

  during the procedure

• The normality of estrus cycle after the treatment

  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

  during the procedure

Secondary Outcomes (1)

• Organs morpholgy after the treatment

  through study completion, an average of 6 months

Study Arms (5)

propolis 50

EXPERIMENTAL

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

Drug: Propolis

propolis 100

EXPERIMENTAL

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

Drug: Propolis

dienogest

ACTIVE COMPARATOR

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

Drug: Dienogest

water

PLACEBO COMPARATOR

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

Other: placebo

sham group

SHAM COMPARATOR

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

Other: placebo

Interventions

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

Also known as: visanne

dienogest

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

Also known as: sulawesian propolis

propolis 100; propolis 50

placebo OTHER

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

sham group; water

Eligibility Criteria

• Gender Eligibility Details: we used female rats to make a model of endometriosis
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• female ratus rat type
• having normal estrus cycle

You may not qualify if:

• nothing

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Animal Laboratory of Indonesia University

Jakarta, Capital Special Region, Indonesia

Location

MeSH Terms

Conditions

Endometriosis

Interventions

dienogest; Propolis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Wachyu Hadisaputra, Prof, dr, SpOG

  Lecturer at Obgyn Department, Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 5, 2020
• Study Start: November 1, 2019
• Primary Completion: May 18, 2020
• Study Completion: May 18, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

ID (1)