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Trial registered on ANZCTR
Registration number
ACTRN12611000074998
Ethics application status
Approved
Date submitted
18/01/2011
Date registered
20/01/2011
Date last updated
20/01/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effects of adjuvant Tualang honey therapy on disease activity markers in systemic lupus erythematosus patients
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Scientific title
A prospective, unblinded, randomised study to evaluate the effect of adjuvant Tualang honey therapy on disease activity markers in systemic lupus erythematosus patients
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Secondary ID [1]
253436
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none
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Universal Trial Number (UTN)
U1111-1119-0723
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
systemic lupus erythematosus
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Condition category
Condition code
Alternative and Complementary Medicine
259118
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0
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Other alternative and complementary medicine
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Inflammatory and Immune System
259122
259122
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Oral Tualang honey 20 gm twice a day
Duration 6 months
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Intervention code [1]
257881
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Treatment: Other
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Comparator / control treatment
active control : standard treatment
maintenance treatment with low dose steroid ( 10 mg ), alone or in combination with immunosuppressive drugs (cyclophosphomide 25 - 50 mg or azathioprine 50 - 100 mg maintenance treatment )
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Control group
Active
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Outcomes
Primary outcome [1]
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reduction of SLEDAI score in the honey group compared to non honey group
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Assessment method [1]
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Timepoint [1]
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6 months
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Primary outcome [2]
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increase in complement level ( enzyme cascade to prevent infection ) in the honey group compared to non honey group.
Complement level is measured by peripheral blood
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Assessment method [2]
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Timepoint [2]
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6 months
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Secondary outcome [1]
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nil
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Assessment method [1]
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Timepoint [1]
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nil
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Eligibility
Key inclusion criteria
SLE patients fulfilled 4 out of 11 ARA criteria
on low dose prednisolone alone or combination with other immunosuppressive drugs and / or either cyclophosphomide or azathioprine maintenance treatment
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Minimum age
13
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
patients who were diabetic, pregnant, suffering from chronic renal failure, cancer, HIV and allergic to honey
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
19/10/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Malaysia
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State/province [1]
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Kelantan
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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School of Medical Sciences, Universiti Sains Malaysia
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Address [1]
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Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan
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Country [1]
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Malaysia
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Primary sponsor type
University
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Name
School of Medical Sciences, Universiti Sains Malaysia
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Address
Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan
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Country
Malaysia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
257501
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Country [1]
257501
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Clinical Sciences, Research Platform Office
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Ethics committee address [1]
260322
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Universiti Sains Malaysia
Health Campus, 16150
Kubang Kerian, Kelantan
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Ethics committee country [1]
260322
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Malaysia
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Date submitted for ethics approval [1]
260322
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Approval date [1]
260322
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18/10/2009
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Ethics approval number [1]
260322
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1001/PPSP/81202016
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Summary
Brief summary
To compare the effects of adjuvant honey therapy versus conventional immunosuppressive therapy alone on disease activity based on disease activity index ( SLEDAI ) score, complement level, ANA and dsDNA in systemic lupus erytematosis patients
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Wan Syamimee Wan Ghazali
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Address
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Department of Internal Medicine, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan
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Country
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Malaysia
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Phone
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+6 09 7673000
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Fax
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+6 09 7673949
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Email
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[email protected]
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Contact person for scientific queries
Name
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Wan Syamimee Wan Ghazali
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Address
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Department of Internal Medicine, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan
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Country
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Malaysia
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Phone
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+6 09 7673000
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Fax
6282
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+6 09 7673949
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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