Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000376741
Ethics application status
Approved
Date submitted
4/04/2013
Date registered
9/04/2013
Date last updated
9/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a combined natural formula (Royal Jelly + Ginkgo biloba + Panax ginseng) versus placebo on the Mini-Mental State Examination Score (MMSE) in patients with mild cognitive impairment
Scientific title
Effect of a combined natural formula (Royal Jelly + Ginkgo biloba + Panax ginseng) versus placebo on the Mini-Mental State Examination Score (MMSE) in patients with mild cognitive impairment
Secondary ID [1] 282243 0
Nil
Universal Trial Number (UTN)
U1111-1141-4415
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 288762 0
Forgetfulness 288809 0
Condition category
Condition code
Mental Health 289121 289121 0 0
Other mental health disorders
Alternative and Complementary Medicine 289122 289122 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combined natural formula in the form of soft gelatin capsules combining 750 mg of lyophilized Royal Jelly with the standardized extracts of Ginkgo biloba 120 mg and Panax ginseng 150 mg per capsule.
The dose is 1 capsule taken daily for 4 weeks.
Adherence to the dose is monitored by calculating the number remained in the container from the 35 capsules.
Intervention code [1] 286859 0
Treatment: Other
Comparator / control treatment
Placebo capsules similar in shape
Control group
Placebo

Outcomes
Primary outcome [1] 289235 0
Change in the baseline MMSE score after treatment
Timepoint [1] 289235 0
4 weeks
Secondary outcome [1] 302080 0
Incidence of serious adverse effects.
The possible adverse events could be any allergic reaction (skin rash, allergic rhinitis, asthmatic attacks or anaphylaxis), headache, flushing, irritability)
The case report form contains a questionnaire for possible drug reactions to remind investigators and patients to report if any.
Patients were also asked to revisit the same clinic as soon as possible to report any adverse event or every 2 weeks if there are no events.
Timepoint [1] 302080 0
4 weeks

Eligibility
Key inclusion criteria
Male or female patients, between 50 and 80 years old, who were complaining of memory impairment or forgetfulness and satisfying the clinical criteria of MCI in the Diagnostic and Statistical Manual of Mental Disorders 4th edition, text revision (DSM-IV-TR) which included: memory complaint, normal activities of daily living, abnormal memory for age and no documented dementia.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
established diagnosis or current treatment for dementia with any drug, any herbal or nutritional supplements except patient with only mild cognitive impairment who stopped treatment for at least one month before enrollment; a baseline MMSE score below 21 or more than 27; or a recent history or current treatment for any specific acquired acute brain injury such as traumatic brain injury (TBI), acute onset stroke, or other acute medical conditions. Patients with a history or current treatment for major depressive or psychotic illnesses as well as critically ill patients or those with severe anemia or vital organ dysfunction “hepatic, renal or cardiac failure” were also excluded.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size (minimum 26 for each group) was calculated to detect a mean difference of 2 points “change from baseline MMSE score” between both treatment groups with estimated group standard deviations of 2.5 and 2.5 and with a significance level (alpha) of 0.05, and 80% power, using a two-sided two-sample t-test.

The MMSE scorings at baseline and after 4 weeks of treatment in both groups were compared using the paired sample t test.
The mean changes in MMSE from baseline after 4 weeks treatment were compared between both treatment groups using the student t test for independent samples as well as a General Linear Model (ANCOVA) adjusting for the effect of age as a covariate and educational levels as a nested factor within treatment groups.
The effects of sex as an independent variable on the mean change in MMSE from baseline after 4 weeks treatment was tested by one way ANOVA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/04/2006
Actual
24/04/2006
Date of last participant enrolment
Anticipated
24/10/2007
Actual
20/02/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 4973 0
Egypt
State/province [1] 4973 0
Alexandria

Funding & Sponsors
Funding source category [1] 287011 0
Charities/Societies/Foundations
Name [1] 287011 0
Green Clinic and research center
Country [1] 287011 0
Egypt
Primary sponsor type
Individual
Name
Mostafa Yakoot
Address
27 Green street 21121, Alexandria, Egypt
Country
Egypt
Secondary sponsor category [1] 285794 0
Commercial sector/Industry
Name [1] 285794 0
Pharco company
Address [1] 285794 0
Alexandria Cairo Desert Road, Km 31, Amriya, Alexandria
P.O.Box 12 Sidi Gaber, Alexandria.
Country [1] 285794 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289051 0
IORG0006902 Green Clinic and Research Center IRB #1
Ethics committee address [1] 289051 0
Ethics committee country [1] 289051 0
Egypt
Date submitted for ethics approval [1] 289051 0
Approval date [1] 289051 0
01/04/2006
Ethics approval number [1] 289051 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38986 0
Dr Mostafa Yakoot
Address 38986 0
Medical director and consultant physician,
Green Clinics and Research Center,
27 Green Street 21121, Alexandria
Country 38986 0
Egypt
Phone 38986 0
+201223927561
Fax 38986 0
+2033913725
Email 38986 0
[email protected]
Contact person for public queries
Name 38987 0
Mostafa Yakoot
Address 38987 0
Medical director and consultant physician,
Green Clinics and Research Center,
27 Green Street 21121, Alexandria
Country 38987 0
Egypt
Phone 38987 0
+201223927561
Fax 38987 0
Email 38987 0
[email protected]
Contact person for scientific queries
Name 38988 0
Mostafa Yakoot
Address 38988 0
Medical director and consultant physician,
Green Clinics and Research Center,
27 Green Street 21121, Alexandria
Country 38988 0
Egypt
Phone 38988 0
+201223927561
Fax 38988 0
+2033913725
Email 38988 0
[email protected]

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.