Guilingji Capsule for Mild-to-moderate Cognitive Impairment

Summary

This study is aiming to evaluate the efficacy and safety of Guilingji capsule in older adults with mild-to-moderate cognitive impairment who diagnosed as the kidney and marrow deficiency pattern in TCM. A total of 348 participants are evenly assigned to two arms. In the intervention arm, participants receive Guilingji capsule and Ginko Biloba Extract mimetic in combination, while the other arm will receive Ginko Biloba Extract tablet with Gulingji mimetic.

Conditions

• Cognitive Dysfunction

Interventions

DRUG

Gulingji capsules

Patients take 0.6g of Gulingji capsules, 2 hours before breakfast, served with light salt water once a day. Also an oral take of 19.2mg Ginko Biloba Extract mimetic three times a day. Treatment lasts for 24 weeks.

DRUG

Ginko Biloba Extract tablet

Patients take 0.6g of Gulingji mimetic, 2 hours before breakfast, served with light salt water once a day. Also an oral take of 19.2mg Ginko Biloba Extract tablet three times a day. Treatment lasts for 24 weeks.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  collaborator OTHER

• Beijing Xuanwu Traditional Chinese Medicine Hospital

  collaborator UNKNOWN

• Beijing Hospital

  collaborator OTHER_GOV

• Beijing Shijitan Hospital, Capital Medical University

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Huadong Hospital

  collaborator OTHER

• Longhua Hospital

  collaborator OTHER

• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  collaborator OTHER

• The Affiliated Hospital of Shandong University of TCM

  collaborator UNKNOWN

• Shanxi Dayi Hospital

  collaborator OTHER

• Shaanxi Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Xiyuan Hospital of China Academy of Chinese Medical Sciences

  lead OTHER

Principal Investigators

• Hao Li · Institute of Geriatrics, Xiyuan Hospital, China Academy of Chinese Medical Sciences,

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-22

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• China

Study Locations