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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000376741

Enrollment

Registered

2013-04-09

Start date

2006-04-24

Completion date

2008-02-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Sixty six subjects presenting with forgetfulness and satisfying the DSM-IV clinical criteria of MCI were randomly divided into an experimental group treated with Memo 1 capsule before breakfast daily for 4 weeks and a control group who took placebo. Mean difference of MMSE score from baseline and reported adverse effects were compared between both groups.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Healthy volunteers

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.

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.

Outcome results