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CompletedNCT02982603Updated Oct 23, 2018

Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment

A Phase 4 interventional study of Qinggongshoutao Bolus and Ginkgo Biloba Extract 761 in Mild Cognitive Impairment and Herbal Medicine Allergy, sponsored by Dongzhimen Hospital, Beijing. Completed at 1 site in China. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-10-23.

Sponsored by Dongzhimen Hospital, Beijing · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled May 2015, registered Nov 2016).
Phase
Phase 4
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
01

Study summary

This study is a 52-weeks, multicenter, randomized, double-blind, double- placebo, parallel controlled phase VI trial being carried out in 20 centers around China. The study population includes amnestic mild cognitive impairment patients (planned a total of 360) aged 55-85 in both gender. Participants will be randomly allocated to Qinggongshoutao bolus (7g per time,2 times per day) and placebo identified to Ginkgo biloba (Ginaton), Ginkgo biloba (Ginaton) (80mg per time, 2 times per day) and placebo identified to Qinggongshoutao bolus, or placebo identified to Qinggongshoutao bolus and placebo identified to Ginkgo biloba (Ginaton) for a 52-weeks double-blind treatment period. The primary outcome measure is change from baseline in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and rate of conversion to dementia. The secondary outcomes are changes from baseline in the Mini-Mental State Examination(MMSE), Delayed Story Recall(DSR), Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24). Safety is being assessed by observing side effects and adverse reaction during the entire treatment period. Statistical analysis will be conducted according to per-protocol population and intend-to-treat population and the safety will be analyzed in safety set.

02

Conditions studied

  • Mild Cognitive Impairment
  • Herbal Medicine Allergy
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 350 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Dongzhimen Hospital, Beijing is the lead sponsor of 43 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. cognitive complaints from the patients or their families;
  2. objective evidence for memory impairment, delayed story recall test(DSR)\<12.6(age50-64 less than15.5,65-74less than 12.5,older 75 less than10);
  3. normal general cognitive function, with Mini-Mental State Examination (MMSE) score of between 24 and 30 (including 30);
  4. preservation of activities of daily living, with Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24) score between 38 and 52;
  5. cognitive disorders as evidenced by clinical evaluation, with clinical dementia rating scale=0.5,memory domain = 0.5;
  6. absence of dementia, not sufficiently impaired cognitively and functionally to meet DSM-IV criteria,
  7. enough vision and hearing to accomplishment neuropsychological test;
  8. capability to read words and write simple sentence;
  9. capability and willingness to give informed consent and to comply with the study procedures.

Exclusion criteria

Exclusion Criteria:

  1. non amnestic Mild cognitive impairment;
  2. meeting the diagnostic criteria for dementia;
  3. cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, epilepsy vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor ,or drug abuse or alcohol abuse
  4. having significant psychiatric disease, depression, the Hamilton depression scale >12; CT or MRI scan showed central nervous system infections Infarction or focal lesions within 12 months，the Hachinski Ischemic Scale (HIS)>4;
  5. combined following disease: diabetes; poor controlled hypertension or severe arrhythmias; or suffered from heart infarction within 3 months; severe asthma or COPD; severe indigestion; gastrointestinal tract obstruction; gastroduodenal ulcer;
  6. used cholinesterase inhibitors or memantine within 1 month;
  7. history of hypersensitivity to the treatment drugs;
  8. concomitant drugs with the potential to interfere with cognition;
  9. administration of other investigational drugs; severe impairment of the functions of the kidney or liver;
  10. vegetarians or contraindications for animal innards.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
350 participants (actual)

Study arms

  • Experimental
    Qinggongshoutao Bolus

    Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761 .Qinggongshoutao bolus 70 pills every time (7g), 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks.

    Drug: Qinggongshoutao Bolus

  • Active comparator
    Ginkgo Biloba Extract 761

    Ginkgo Biloba Extract 761 and placebo identified to Qinggongshoutao bolus.The subjects will take Ginkgo Biloba Extract 761 2 times per day, 2 pills per time(80mg) ,and identified to Qinggongshoutao bolus 70 pills every time, 2 times per day for 48 weeks.

    Drug: Ginkgo Biloba Extract 761

  • Placebo comparator
    Placebos

    Placebo identified to Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761.Placebo identified to Qinggongshoutao bolus 70 pills every time, 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks.

    Drug: Placebos

Interventions

  • DrugQinggongshoutao Bolus

    Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761

    Also known as: Ginkgo biloba also named Egb761 or Ginaton

  • DrugGinkgo Biloba Extract 761

    Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761

    Also known as: Ginkgo biloba also named Egb761 or Ginaton

  • DrugPlacebos

    Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba

06

What researchers measure

Primary outcomes

  1. Change from baseline to end of double-blind treatment of Alzheimer Disease Assessment Scale-cognitive subscale

    Time frame: week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.

  2. Change from baseline to end of double-blind treatment of rate of conversion to dementia

    Time frame: week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.

Secondary outcomes

  1. Mini-Mental State Examination(MMSE)

    Time frame: week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.

  2. Change from baseline to end of double-blind treatment of Delayed Story Recall test (DSR)

    Time frame: week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.

  3. Change from baseline to end of double-blind treatment of Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24)

    Time frame: week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.

07

Study locations

1 site
  • Dongzhimen Hospital ,Beijing University of Chinese Medicine
    Beijing, Beijing 100700, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02982603
Lead sponsor
Dongzhimen Hospital, Beijing
Responsible party
Jinzhou Tian (Clinical Professor, Dongzhimen Hospital, Beijing) — Principal investigator
First posted
Dec 5, 2016
Start date
May 2015
Primary completion
Dec 2017
Completion
Dec 2017
Last update
Oct 23, 2018

Study contacts

Jinzhou Tian, M.D,PhD
principal investigator · Dongzhimen Hospital, Beijing University of Chinese Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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