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Efficacy and Safety of Qi Zhi Tong Luo Capsule in Vascular Cognitive Impairment

NCT04301466 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2020-03-11

No results posted yet for this study

Summary

Qi Zhi Tong Luo (QZTL) capsule, a traditional Chinese herbal medicine, which was used to treat stoke-related symptoms, include trouble speaking, paralysis and trouble walking. This study aimed to evaluate the efficacy and safety of QZTL capsule in the treatment of vascular cognitive impairment. This study was designed as randomized, double-blind, parallel, placebo-controlled, multicentre trial. It consisted of a single-blind run-in period using placebo only (2 weeks) and a double-blind treatment phase after randomization (24 weeks), and follow-up 12 weeks after withdrawal.The primary efficacy variables included changes from baseline in the Clinical Dementia Rating scale-Sum Box (CDR-SB) and the Mini-mental State Examination (MMSE) after 24 weeks of treatment. The secondary efficacy measurements include the Clock Drawing Test (CDT), Hopkins Verbal Learning Test (HVLT) and Ability of Daily Living (ADL).

Conditions

  • Vascular Cognitive Impairment
  • Qi Zhi Tong Luo Capsule
  • Randomized Controlled Trial

Interventions

DRUG

Qi Zhi Tong Luo capsule

Patients were receiveed Qi Zhi Tong Luo Capsule 4 capsules, 2 times per day for 24 weeks. QZTL capsule, a traditional Chinese medicine. Each capsule was weighted 0.5g.

DRUG

Placebos

Patients were allocated to placebo, 4 capsules, 2 times per day for 24 weeks.To preserve blinding, the placebo had an identical taste and appearance to the experimental drugs. Placebo (batch number: 20140805) were produced by Shanxi Zhendong Pharmaceutical Co., Ltd.

Sponsors & Collaborators

  • Shanxi Zhendong Pharmacy Co., Ltd

    collaborator INDUSTRY

  • Dongzhimen Hospital, Beijing

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-16
Primary Completion
2018-05-30
Completion
2018-05-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04301466 on ClinicalTrials.gov