Chronic Thrombocytopenic PurpuraNCT01462916
Honey in Chronic Immune Thrombocytopenia
An observational study of Chronic Thrombocytopenic Purpura, run by mamdouh abdulmaksoud abdulrhman at 1 site in Egypt.
Trial summary
Based on the assumption that honey may have an immunomodulatory effect, the aim of our present study will be to verify whether the intake of honey, as a natural substance, in patients with chronic Immune Thrombocytopenia (ITP) could affect the platelet number and hence could affect the bleeding severity. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Chronic Thrombocytopenic Purpura
- What is being tested?
- honey
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2014to Dec 2017
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Thirty patients suffering from chronic immune thrombocytopenic purpura (ITP) will be recruited from the Hematology Clinic of the Pediatric Hospital of Ain Shams University,Egypt. The age of the patients will range from 5 to 15 years, and they will be of both sexes.
Who may be able to join
- Patients with chronic ITP who did not receive any treatment specific for ITP within the past 3 months
- Who did not receive bee honey or any medication that may affect platelet number or function within the past 3 months and
- In whom the bleeding severity will range from 1 to 3 (mild to moderate bleeding) according to Buchanan and Adix (2002).
Who cannot join
- Grade 4 bleeding severity, according Buchanan and Adix (2002) and
- Presence of diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric Department, Faculty of Medicine, Ain Shams University
Cairo
About this study
Official title: Effect of Honey Bee Honey Intake on Children With Chronic Immune Thrombocytopenia
Based on the assumption that honey may have an immunomodulatory effect, the aim of our present study will be to verify whether the intake of honey, as a natural substance, in patients with chronic Immune Thrombocytopenia (ITP) could affect the platelet number and hence could affect the bleeding severity. Thirty patients suffering from chronic ITP will be recruited from the Hematology Clinic of the Pediatric Hospital of Ain Shams University, Cairo, Egypt. The diagnosis of ITP will be based on the presence of isolated thrombocytopenia with a peripheral blood platelet count less than 100 x 109/L, and absence of any obvious initiating and/or underlying cause of the thrombocytopenia. Chronic ITP is defined as ITP for at least 12 months. The age of the patients will range from 5 to 15 years, and they will be of both sexes. This study was approved by the local Ethics Committee of the Pediatric Department of Ain Shams University, and an informed consent to participate in this study will be obtained from at least one parent of each patient. Furthermore, an ascent form will be obtained from each patient above 7 years of age.
Read the detailed description
Study design:
A crossover design (two 12-weeks intervention periods) will be used to measure treatment effects. The subjects will be randomized into two groups (intervention to control [I/C] and control to intervention [C/I] groups). Each study group will have 15 subjects. The subjects in the I/C group will consume 2 ml honey/kg/dose (maximum 50 ml/dose), twice weekly in the first 12-week period (period 1) while the subjects in the C/I group will not receive honey as a Control in period 1. After period 1 the subjects of each group will exchange their protocol for the following 12-week period (period 2). This design will allow the treatment effects to be measured between the study groups (namely between the different subjects) in the same study period, or period 1, as well as in the same subjects in a crossover comparison of periods 1 and 2.
- Conditions
- Chronic Thrombocytopenic Purpura
- Being tested
- honey
- Keywords
- honey, mucositis, bee products
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
honeyDietary supplement
A crossover design (two 12-weeks intervention periods) will be used to measure treatment effects. The subjects will be randomized into two groups (intervention to control [I/C] and control to intervention [C/I] groups). Each study group will have 15 subjects. The subjects in the I/C group will consume 2 ml honey/kg/dose (maximum 50 ml/dose), twice weekly in the first 12-week period (period 1) while the subjects in the C/I group will not receive honey as a Control in period 1. After period 1 the subjects of each group will exchange their protocol for the following 12-week period (period 2).
| Study group | Role | What they receive |
|---|---|---|
| honey, no honey | Not described Receives: Dietary Supplement: honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding severity
Bleeding severity will be assessed clinically at least twice weekly and whenever indicated through telephone contact with parents or guardian At least twice weekly for 24 weeks
Measured: up to 24 weeks
Secondary outcomes (1)
Platelet count
Both bleeding severity and platelet count will be assessed at least twice weekly and whenever indicated through telephone contact with parents or guardian At least twice weekly for 24 weeks
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startOct 2014
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: problem with the candidate (investigator)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thrombocytopenic PurpuraStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- mamdouh abdulmaksoud abdulrhman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, mamdouh abdulmaksoud abdulrhman, Ain Shams University
- Investigators
- Mamdouh Abdulrhman, Prof, Principal investigator, professorMohsen El Alfy, prof, Principal investigator, professorAbeer Abdulmaksoud, MD, Principal investigator, Assistant ProfessorAbeer Saad, MD, Principal investigator, Assistant professorMay Said, Principal investigator, Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462916
- Sponsor's protocol ID
- ITP 123
- Status last verified
- Jan 2018
- First submitted
- 21 Oct 2011
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Honey Bee Honey Intake on Children With Chronic Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT01462916
- Acronym / sponsor ID
- ITP 123
- Conditions
- Chronic Thrombocytopenic Purpura
- Keywords
- honey, mucositis, bee products
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: problem with the candidate (investigator)
- Enrolment
- 30 participants (actual)
- Lead sponsor
- mamdouh abdulmaksoud abdulrhmanUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 Nov 2011 (estimated)
- 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.
Based on the assumption that honey may have an immunomodulatory effect, the aim of our present study will be to verify whether the intake of honey, as a natural substance, in patients with chronic Immune Thrombocytopenia (ITP) could affect the platelet number and hence could affect the bleeding severity. Thirty patients suffering from chronic ITP will be recruited from the Hematology Clinic of the Pediatric Hospital of Ain Shams University, Cairo, Egypt. The diagnosis of ITP will be based on the presence of isolated thrombocytopenia with a peripheral blood platelet count less than 100 x 109/L, and absence of any obvious initiating and/or underlying cause of the thrombocytopenia. Chronic ITP is defined as ITP for at least 12 months. The age of the patients will range from 5 to 15 years, and they will be of both sexes. This study was approved by the local Ethics Committee of the Pediatric Department of Ain Shams University, and an informed consent to participate in this study will be obtained from at least one parent of each patient. Furthermore, an ascent form will be obtained from each patient above 7 years of age.
Detailed description
Study design:
A crossover design (two 12-weeks intervention periods) will be used to measure treatment effects. The subjects will be randomized into two groups (intervention to control [I/C] and control to intervention [C/I] groups). Each study group will have 15 subjects. The subjects in the I/C group will consume 2 ml honey/kg/dose (maximum 50 ml/dose), twice weekly in the first 12-week period (period 1) while the subjects in the C/I group will not receive honey as a Control in period 1. After period 1 the subjects of each group will exchange their protocol for the following 12-week period (period 2). This design will allow the treatment effects to be measured between the study groups (namely between the different subjects) in the same study period, or period 1, as well as in the same subjects in a crossover comparison of periods 1 and 2.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| honey, no honey | – | Dietary Supplement: honey |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Thirty patients suffering from chronic immune thrombocytopenic purpura (ITP) will be recruited from the Hematology Clinic of the Pediatric Hospital of Ain Shams University,Egypt. The age of the patients will range from 5 to 15 years, and they will be of both sexes.
Key inclusion criteria (3 listed)
- Patients with chronic ITP who did not receive any treatment specific for ITP within the past 3 months
- Who did not receive bee honey or any medication that may affect platelet number or function within the past 3 months and
- In whom the bleeding severity will range from 1 to 3 (mild to moderate bleeding) according to Buchanan and Adix (2002).
Key exclusion criteria (2 listed)
- Grade 4 bleeding severity, according Buchanan and Adix (2002) and
- Presence of diabetes mellitus.
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 |
|---|---|---|
| honeyA crossover design (two 12-weeks intervention periods) will be used to measure treatment effects. The subjects will be randomized into two groups (intervention to control [I/C] and control to intervention [C/I] groups). Each study group will have 15 subjects. The subjects in the I/C group will consume 2 ml honey/kg/dose (maximum 50 ml/dose), twice weekly in the first 12-week period (period 1) while the subjects in the C/I group will not receive honey as a Control in period 1. After period 1 the subjects of each group will exchange their protocol for the following 12-week period (period 2). | Dietary supplement | honey, no honey |
Primary outcome
Bleeding severity
Time frame: up to 24 weeks
Bleeding severity will be assessed clinically at least twice weekly and whenever indicated through telephone contact with parents or guardian At least twice weekly for 24 weeks
1 secondary outcome
Platelet count
Time frame: up to 24 weeks
Results and safety
The study was stopped early (reason given: problem with the candidate (investigator)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Ain Shams University, EgyptLink provided by the sponsor.
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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.
Mamdouh Abdulrhman, Prof principal investigator
professor
Mohsen El Alfy, prof principal investigator
professor
Abeer Abdulmaksoud, MD principal investigator
Assistant Professor
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 Chronic Thrombocytopenic Purpura, run by mamdouh abdulmaksoud abdulrhman at 1 site in Egypt.
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 3 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: stopped early, as of the sponsor's last update on 9 Jan 2018. 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 Egypt. 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 was stopped early (reason given: problem with the candidate (investigator)). Results are not available in the source record.
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?
Bleeding severity (time frame: up to 24 weeks). 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 9 Jan 2018.