NCT05643599

Brief Summary

For our working group, eighteen healthy Sprague-Dawley female rats were recruited and separated into three groups in an experimental animal laboratory. Group 1 was given mad honey (n:6) (80 mg/kg); Group 2 was given normal honey (n:6) (80 mg/kg), and Group 3 was the control group (n:6). The groups were given normal and mad honey by oral gavage for 30 days in this study. Rats were anesthetized intramuscularly with 50 mg/kg ketamine and 5 mg/kg xylazine on the 30th day of the study. At the conclusion of the study, female rats in the proestrus phase of the estrous cycle (as indicated by vaginal smear) were sacrificed and their ovarian tissues were placed in neutral formalin solution.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

14 days

First QC Date

November 30, 2022

Last Update Submit

January 24, 2025

Conditions

Keywords

Grayonotoxin; Mad Honey; Normal honey; ovary

Outcome Measures

Primary Outcomes (1)

  • Comparison of the Mad Honey and Normal Honey findings of the ovary tissue specimens

    Analyses of the relationship between oxidative stress and apoptosis of histopathological changes made by mad honey containing grayanotoxin in the ovary

    Baseline

Study Arms (3)

Group 1:

Mad honey

Dietary Supplement: Mad Honey

Group 2:

Normal honey

Dietary Supplement: Normal Honey

Group 3:

without intervention

Dietary Supplement: Control

Interventions

Mad HoneyDIETARY_SUPPLEMENT

mad honey (80 mg/kg); (n:6)

Group 1:
Normal HoneyDIETARY_SUPPLEMENT

normal honey (80 mg/kg),(n:6)

Group 2:
ControlDIETARY_SUPPLEMENT

Control

Group 3:

Eligibility Criteria

Age8 Weeks - 10 Weeks
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

experimental animals ( Sprague Dawley rats)

You may qualify if:

  • healthy rats

You may not qualify if:

  • patient rats
  • not eating rats

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hayrunnisa

Yunusemre, Mani̇sa, 45030, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

ovary tissue

MeSH Terms

Conditions

Ovarian Diseases

Condition Hierarchy (Ancestors)

Adnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Gulsen Gurgen

    Manisa Celal Bayar University

    STUDY CHAIR
  • Suha Turkmen

    Karadeniz Teknik University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Prof.

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 8, 2022

Study Start

December 1, 2022

Primary Completion

December 15, 2022

Study Completion

December 31, 2022

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations