Ovary DiseaseNCT05643599
The Relationship With Mad Honey Containing Grayanotoxin and Ovary Tissue
An observational study of Ovary Disease, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 10 weeks, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovary Disease
- What is being tested?
- Mad Honey and Normal Honey
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 weeks
- Women only
- Healthy volunteers accepted
- Child
Study population: experimental animals ( Sprague Dawley rats)
Who may be able to join
- healthy rats
Who cannot join
- patient rats
- not eating rats
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Oxidative Stress and Apoptosis of Histopathological Changes Made by Mad Honey Containing Grayanotoxin in the Ovary
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.
Read the detailed description
Honey poisoning is caused by consuming honey produced by bees that feed on Rhododendron family plants. Rhododendron poisoning goes by names such as mad honey poisoning or grayanotoxin poisoning. The purpose of this study is to determine the effects of grayanotoxin in mad honey on ovarian tissue folliculogenesis in terms of cell death and nitric oxide expression. Three groups of 18 female Sprague-Dawley rats were formed. The first group received mad honey (80 mg/kg), the second group received normal honey (80 mg/kg), and the third group is control. The first and second groups received normal and mad honey by oral gavage for 30 days before being sacrificed under anesthesia The caspase 3 immunostaining group observed a moderate to a strong response, particularly in the granulosa cells of the Graaf follicles in the mad honey group, while the normal honey and control groups observed a weak to moderate reaction. In the mad honey group, immunostaining for caspase8 and caspase 9 revealed a moderate immunoreaction in the granulosa cells of the Graaf follicles, while expression was weak in the normal honey and control groups. The TUNEL approach revealed that the majority of Graaf follicles that exhibited TUNEL positive in the mad honey group and progressed to atresia were Graaf follicles. The iNOS immunoreaction revealed a high level of expression in the mad honey group, particularly in several Graaf follicles. In all three groups, a weak reactivity to eNOS immunostaining was seen in both Graaf follicles and theca external layers. According to the findings of apoptotic and nitric oxide marker expression, it was determined that mad honey may result in an increase in follicular atresia in ovarian follicles when compared to normal honey and control groups.
- Conditions
- Ovary Disease
- Being tested
- Mad Honey, Normal Honey, Control
- Keywords
- Grayonotoxin; Mad Honey; Normal honey; ovary
- Medical subject headings
- Ovarian Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mad HoneyDietary supplement
mad honey (80 mg/kg); (n:6)
Normal HoneyDietary supplement
normal honey (80 mg/kg),(n:6)
ControlDietary supplement
Control
| Study group | Role | What they receive |
|---|---|---|
| Group 1: | Mad honey Receives: Dietary Supplement: Mad Honey | |
| Group 2: | Normal honey Receives: Dietary Supplement: Normal Honey | |
| Group 3: | without intervention Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Dec 2022
- Primary completion15 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayrunnisa Yesil Sarsmaz, Manisa Celal Bayar University
- Investigators
- Gulsen Gurgen, Study chair, Manisa Celal Bayar UniversitySuha Turkmen, Study chair, Karadeniz Teknik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643599
- Sponsor's protocol ID
- MCBU_Madhoney
- Status last verified
- Jan 2025
- First submitted
- 30 Nov 2022
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Oxidative Stress and Apoptosis of Histopathological Changes Made by Mad Honey Containing Grayanotoxin in the Ovary
- ClinicalTrials.gov ID
- NCT05643599
- Acronym / sponsor ID
- MCBU_Madhoney
- Conditions
- Ovary Disease
- Keywords
- Grayonotoxin; Mad Honey; Normal honey; ovary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Honey poisoning is caused by consuming honey produced by bees that feed on Rhododendron family plants. Rhododendron poisoning goes by names such as mad honey poisoning or grayanotoxin poisoning. The purpose of this study is to determine the effects of grayanotoxin in mad honey on ovarian tissue folliculogenesis in terms of cell death and nitric oxide expression. Three groups of 18 female Sprague-Dawley rats were formed. The first group received mad honey (80 mg/kg), the second group received normal honey (80 mg/kg), and the third group is control. The first and second groups received normal and mad honey by oral gavage for 30 days before being sacrificed under anesthesia The caspase 3 immunostaining group observed a moderate to a strong response, particularly in the granulosa cells of the Graaf follicles in the mad honey group, while the normal honey and control groups observed a weak to moderate reaction. In the mad honey group, immunostaining for caspase8 and caspase 9 revealed a moderate immunoreaction in the granulosa cells of the Graaf follicles, while expression was weak in the normal honey and control groups. The TUNEL approach revealed that the majority of Graaf follicles that exhibited TUNEL positive in the mad honey group and progressed to atresia were Graaf follicles. The iNOS immunoreaction revealed a high level of expression in the mad honey group, particularly in several Graaf follicles. In all three groups, a weak reactivity to eNOS immunostaining was seen in both Graaf follicles and theca external layers. According to the findings of apoptotic and nitric oxide marker expression, it was determined that mad honey may result in an increase in follicular atresia in ovarian follicles when compared to normal honey and control groups.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: | – | Dietary Supplement: Mad HoneyMad honey |
| Group 2: | – | Dietary Supplement: Normal HoneyNormal honey |
| Group 3: | – | Dietary Supplement: Controlwithout intervention |
Who may qualify
- Ages
- 8 to 10 weeks
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- experimental animals ( Sprague Dawley rats)
Key inclusion criteria (1 listed)
- healthy rats
Key exclusion criteria (2 listed)
- patient rats
- not eating rats
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mad Honeymad honey (80 mg/kg); (n:6) | Dietary supplement | Group 1: |
| Normal Honeynormal honey (80 mg/kg),(n:6) | Dietary supplement | Group 2: |
| ControlControl | Dietary supplement | Group 3: |
Primary outcome
Comparison of the Mad Honey and Normal Honey findings of the ovary tissue specimens
Time frame: Baseline
Analyses of the relationship between oxidative stress and apoptosis of histopathological changes made by mad honey containing grayanotoxin in the ovary
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulsen Gurgen study chair
Manisa Celal Bayar University
Suha Turkmen study chair
Karadeniz Teknik University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovary Disease, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Mad Honey and Normal Honey findings of the ovary tissue specimens (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.