Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke

Completed

Phase 4 Results N/A

Trial Description

This is a 20-week study consisting of a 12-week multicenter, randomized,double-blind adaptive study to compare efficacy and safety of Qizhitongluo Capsule,Naoxintong Capsule and placebo in the recovery phase of ischemic stroke with qi deficiency and blood stasis syndrome, and a 8-week post-treatment safety follow-up.After 312 patients complete 12 weeks of treatment there will be an interim analysis.

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Qizhitongluo Capsule
    Description: Basic treatment:Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per nighit;the routine recovery training. intervention treatment:the Capsules were administered orally, four capsules each time, three times a day after each meal(placebo was taken only after lunch, and Qizhitongluo Capsulue was tanken after breafast and supper)for 12 weeks.
    ARM 2: Kind: Experimental
    Label: Placebo
    Description: Basic treatment:Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per nighit and the routine recovery training. intervention treatment:placebo capsule was administered orally four capsules each time, three times a day after each meal for 12 weeks.
  • Qizhitongluo Capsule Drug
    Other Names: QZTL group
    ARM 1: Kind: Experimental
    Label: Qizhitongluo Capsule
    Description: Basic treatment:Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per nighit;the routine recovery training. intervention treatment:the Capsules were administered orally, four capsules each time, three times a day after each meal(placebo was taken only after lunch, and Qizhitongluo Capsulue was tanken after breafast and supper)for 12 weeks.
  • Naoxintong Capsule Drug
    Other Names: Chinese Herbal Compound
    ARM 1: Kind: Experimental
    Label: Naoxintong Capsule
    Description: Basic treatment:Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per nighit; the routine recovery training. intervention treatment:Naoxintong Capsule was administered orally, four capsules each time, three times a day after each meal for 12 weeks.
  • Aspirin Enteric-coated Tablets Drug
    ARM 1: Kind: Experimental
    Label: Qizhitongluo Capsule
    Description: Basic treatment:Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per nighit;the routine recovery training. intervention treatment:the Capsules were administered orally, four capsules each time, three times a day after each meal(placebo was taken only after lunch, and Qizhitongluo Capsulue was tanken after breafast and supper)for 12 weeks.
    ARM 2: Kind: Experimental
    Label: Naoxintong Capsule
    Description: Basic treatment:Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per nighit; the routine recovery training. intervention treatment:Naoxintong Capsule was administered orally, four capsules each time, three times a day after each meal for 12 weeks.
    ARM 3: Kind: Experimental
    Label: Placebo
    Description: Basic treatment:Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per nighit and the routine recovery training. intervention treatment:placebo capsule was administered orally four capsules each time, three times a day after each meal for 12 weeks.
  • The routine recovery training Behavioral
    ARM 1: Kind: Experimental
    Label: Qizhitongluo Capsule
    Description: Basic treatment:Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per nighit;the routine recovery training. intervention treatment:the Capsules were administered orally, four capsules each time, three times a day after each meal(placebo was taken only after lunch, and Qizhitongluo Capsulue was tanken after breafast and supper)for 12 weeks.
    ARM 2: Kind: Experimental
    Label: Naoxintong Capsule
    Description: Basic treatment:Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per nighit; the routine recovery training. intervention treatment:Naoxintong Capsule was administered orally, four capsules each time, three times a day after each meal for 12 weeks.
    ARM 3: Kind: Experimental
    Label: Placebo
    Description: Basic treatment:Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per nighit and the routine recovery training. intervention treatment:placebo capsule was administered orally four capsules each time, three times a day after each meal for 12 weeks.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary the Lower Extremity Fugl-Meyer score measured at baseline and 4, 8 and 12 weeks No
Secondary Aphasia Quotient(AQ) score measured at baseline and 4, 8 and 12 weeks No
Secondary the incidence of Barthel Index score ≥90 measured at baseline and 4, 8 and 12 weeks No
Secondary the Upper Extremity Fugl-Meyer score measured at baseline and 4, 8 and 12 weeks No
Secondary the total Fugl-Meyer motor score measured at baseline and 4, 8 and 12 weeks No
Secondary the syndrome score of Qi Deficiency and Blood Stasis measured at baseline and 4, 8 and 12 weeks No
Secondary the incidence of New-onset cardiovascular events during the 20-weeks Yes
Secondary the level of blood glucose (BG)、Lipid Profile、blood clotting tetrachoric measured at baseline and 12 weeks No
Secondary physical examination、 laboratory tests and ECG measured at baseline and 12 weeks Yes
Secondary the incidence of adverse event during the 20-weeks Yes
Secondary all cause mortality during the 20-weeks Yes
Secondary NHISS score measured at baseline and 4, 8 and 12 weeks No
Primary change in the Lower Extremity Fugl-Meyer score baseline, after 4,12 weeks of treatment, after 90 days of onset. No
Secondary Change in Aphasia Quotient(AQ) score baseline, after 4,12 weeks of treatment, after 90 days of onset. No
Secondary Change in Barthel Index score and proportion of subjects with Barthel Index score ≥90 baseline, after 4,12 weeks of treatment, after 90 days of onset. No
Secondary Change in the Upper Extremity Fugl-Meyer score baseline, after 4,12 weeks of treatment, after 90 days of onset. No
Secondary Change in the total Fugl-Meyer motor score baseline, after 4,12 weeks of treatment, after 90 days of onset. No
Secondary Change in the syndrome score of Qi Deficiency and Blood Stasis baseline, after 4,12 weeks of treatment, after 90 days of onset. No
Secondary Changes in plasma glucose and lipid concentrations and blood coagulate baseline and after 12 weeks of treatment Yes
Secondary the incidence of adverse events during the 20-weeks Yes

Sponsors