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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
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
Secondary ID [1] 253436 0
none
Universal Trial Number (UTN)
U1111-1119-0723
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
systemic lupus erythematosus 260986 0
Condition category
Condition code
Alternative and Complementary Medicine 259118 259118 0 0
Other alternative and complementary medicine
Inflammatory and Immune System 259122 259122 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral Tualang honey 20 gm twice a day
Duration 6 months
Intervention code [1] 257881 0
Treatment: Other
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 )
Control group
Active

Outcomes
Primary outcome [1] 261971 0
reduction of SLEDAI score in the honey group compared to non honey group
Timepoint [1] 261971 0
6 months
Primary outcome [2] 261992 0
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
Timepoint [2] 261992 0
6 months
Secondary outcome [1] 268899 0
nil
Timepoint [1] 268899 0
nil

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
Minimum age
13 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients who were diabetic, pregnant, suffering from chronic renal failure, cancer, HIV and allergic to honey

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3145 0
Malaysia
State/province [1] 3145 0
Kelantan

Funding & Sponsors
Funding source category [1] 258350 0
University
Name [1] 258350 0
School of Medical Sciences, Universiti Sains Malaysia
Address [1] 258350 0
Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan
Country [1] 258350 0
Malaysia
Primary sponsor type
University
Name
School of Medical Sciences, Universiti Sains Malaysia
Address
Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan
Country
Malaysia
Secondary sponsor category [1] 257501 0
None
Name [1] 257501 0
Address [1] 257501 0
Country [1] 257501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260322 0
Clinical Sciences, Research Platform Office
Ethics committee address [1] 260322 0
Universiti Sains Malaysia
Health Campus, 16150
Kubang Kerian, Kelantan
Ethics committee country [1] 260322 0
Malaysia
Date submitted for ethics approval [1] 260322 0
Approval date [1] 260322 0
18/10/2009
Ethics approval number [1] 260322 0
1001/PPSP/81202016

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32107 0
Address 32107 0
Country 32107 0
Phone 32107 0
Fax 32107 0
Email 32107 0
Contact person for public queries
Name 15354 0
Wan Syamimee Wan Ghazali
Address 15354 0
Department of Internal Medicine, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan
Country 15354 0
Malaysia
Phone 15354 0
+6 09 7673000
Fax 15354 0
+6 09 7673949
Email 15354 0
syamimee@kb.usm.my
Contact person for scientific queries
Name 6282 0
Wan Syamimee Wan Ghazali
Address 6282 0
Department of Internal Medicine, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan
Country 6282 0
Malaysia
Phone 6282 0
+6 09 7673000
Fax 6282 0
+6 09 7673949
Email 6282 0
syamimee@kb.usm.my

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary