CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 324 enrolled
Drug / intervention
Shenwu Capsule +1 moredrug
Likely dose
Shenwu Capsule 451 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01451749
NCT01451749Phase 3Completed
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Phase III Study of Shenwu Capsule in Treating Amnestic Mild Cognitive Impairment

North China Pharmaceutical Group Corporation·interventional·Posted Oct 14, 2011·Updated Oct 10, 2014

In Brief

A Phase 3 clinical trial evaluating Shenwu Capsule and Donepezil for Mild Cognitive Impairment. Completed, enrolled 324 participants across 1 site.

Detailed Summary

The purpose of this phase III study is to further evaluate the effects of shenwu capsule, a traditional Chinese herbal medicine, on cognition, function and memory in patients with amnestic mild cognitive impairment (MCI) who are at greater risk for developing Alzheimer's disease, in a 6-month supervised protocol of a traditional Chinese herbal medicine. The results of this study may provide support for a relatively simple and inexpensive treatment strategy with herbal therapy that specifically targets individuals with the mild cognitive impairment that directly influence risk of developing dementia for older adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild Cognitive Impairment
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 14, 2011
Enrollment StartSep 1, 2008
Primary CompletionMay 1, 2009
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.7 years ago

Interventions

Shenwu Capsuledrug

1 shenwu capsule contains 451 mg extract from herbs.5 capsules/time, 3 times/day for 6 months. Placebo identified to donepezil: 1 tablet per time, 1 time per day for 6 months.

Donepezildrug

This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months. Placebo identical to shenwu capsules,5 capsules/time,3times/day for 6months.