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Huanshao capsule treat amnestic mild cognitive impairment (the spleen and kidney deficiency syndrome)

The effects and safety of Huanshao capsule for the treatment of amnestic mild cognitive impairment (the spleen and kidney deficiency syndrome) and outcome effects:randomized, double-blind, parallel controled , multi-center clinical trial study with placebo-controlled

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009085
Enrollment
Unknown
Registered
2016-08-25
Start date
2016-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Amnestic mild cognitive impairment

Interventions

A group:test drug

Sponsors

Dongzhimen hospital,Beijing Univercity of Chinese Medcine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjective memory complaints confirmed by others; 2. The objective memory loss of the inconsistent with the age; 3. The cognitive function at the normal leve; 4. ADL at the normal leve; 5. no dementia; 6. The spleen and kidney deficiency syndrome; 7. Aged from 55 to 85 years; 8. Sufficient visual and auditory resolution acceptable neuropsychological tests; 9. There is a certain level of education, read simple texts and write simple sentences; 10. Patients sign informed consent.

Exclusion criteria

Exclusion criteria: 1. naMCI; 2. Dementia caused by various factors according with diagnostic criteria for dementia (DSM-IV-R); 3. Sleep disorder ; overreliance on drug or alcohol within 5-year-long, etc. leading to cognitive performance; 4. CT or MRI scan showed the central nervous system infection, infarction, other focal damage in the past 12 months; Haijinsiji Ischemic Scale (HIS) > 4 points; 5. The cases which are not suitable in this study are as follow: being high blood pressure patients still though taking corresponding drugs; patients with serious arrhythmia or with or cardiac function grade 3 ~ 4; patients suffering from myocardial infarction before attending the test; 6. The patient having used a cholinesterase inhibitor or Memantine during the past month or the patients being not qualified by screening out; 7. Patients taking Chinese medicine, Anticholinergics, anticonvulsants, anti-Parkinson drugsexcitability drugs,anticholinergics, antipsychotics, or anticholinergic drugs or pro-cholinergic effects of antidepressants or anti-anxiety drugs at the same time and those knowing to be allergic to these; 8. Patients showing severe liver and kidney dysfunction, such as liver function (ALT and AST) 1.5 times over upper level of standard range, or creatine being above standard range; 9. Patients with severe asthma and chronic obstructive pulmonary disease (COPD); 10. Patients with Serious indigestion, gastrointestinal obstruction, gastric or duodenal ulcer etc; 11. Patients taking part in other clinical research; 12. Subjects being identified as disobedient by researchers.

Design outcomes

Primary

MeasureTime frame
ADAS-cog;CDR;

Secondary

MeasureTime frame
DSR;MMSE;ADCS-MCI-ADL;CGIC-PES;

Countries

China

Contacts

Public ContactJing Shi

Dongzhimen hospital,Beijing Univercity of Chinese Medcine

346395869@qq.com+86 13910608987

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026