Clinical Study on Huatuo Zaizao Pills for Post-stroke Treatment

Last updated: November 25, 2024
Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Overall Status: Completed

Phase

4

Condition

Stroke

Thrombosis

Blood Clots

Treatment

basic treatment

Huatuo Zaizao Pills

HuaTuo Zaizao pill

Clinical Study ID

NCT04910256
XiyuanH-huatuo zaizao pill
  • Ages 35-75
  • All Genders

Study Summary

The purpose of this study was to evaluate the improvement of limb motor function and nerve function of patients with HTZZ during stroke rehabilitation. A total of 80 subjects will be randomly assigned to Huatuo Zaizao pill group or the control group.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.Aged between 35 and 75 years old

  • 2.With a disease course between 2 weeks- 24weeks

  • 3.Meeting the diagnostic criteria of ischemic stroke

  • 4.Signed and dated written informed consent.

  • 5.4≤NIHSS score≤22

Exclusion

Exclusion Criteria:

  • 1.Unstable vital signs, or serious heart, liver, lung, kidney and other organdiseases

  • 2.Exclude Transient Ischemic Attack(TIA)

  • 3.Patients who are participating in clinical trials of other drugs within the past 1month

  • 4.Pregnant or breastfeeding women

  • 5.Athletes, Epileptics, Allergic to this product

Study Design

Total Participants: 80
Treatment Group(s): 4
Primary Treatment: basic treatment
Phase: 4
Study Start date:
May 31, 2021
Estimated Completion Date:
September 30, 2023

Study Description

This is a prospective, randomized controlled clinical trial. Eighty patients with phlegm and blood stasis block syndrome of ischemic stroke were randomly assigned to Hua Hua reconstruction group or control group at a ratio of 1:1. The treatment period is 12 weeks. The purpose is to evaluate its efficacy and safety, provide an objective basis for precise treatment of traditional Chinese medicine, and improve clinical efficacy. The main result is the changes of MAS scores 12 weeks days after taking the drug. The secondary result is the change in NIHSS, Fugl-Meyer and BI.

Connect with a study center

  • Xiyuan Hospital, China Academy of Chinese Medical Sciences

    Beijing, Beijing 10091
    China

    Site Not Available

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