Efficacy Study of Huatuo Zaizao Pills in Improving of Neural Function in

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine the efficacy of Huatuo Zaizao Pills in improving neural function and life quality in patients with acute ischemic stroke in China.

Clinical Trial Description

Huatuo Zaizao Pills is a pure natural preparation from plant origin and consists of Chuanxiong rhizome, Evodia fruit and etc. Most of its ingredients are not opened and reserved by the National Commission for Science and Technology and the State Food and Drug Administration.

Huatuo Zaizao Pills was approved for marketing as a drug over several decades for treating and preventing cardiovascular and cerebrovascular diseases and their sequela. It is used to symptoms induced by blood stasis or stagnation of phlegm-wetness, such as stroke and paralysis, stiffness and numbness, deviation of the eye and mouth and dysphasia.

Based on the history of Huatuo Zaizao Pills for the treatment of cerebral infarction and hemorrhagic stroke, investigators will perform a phase IV, double blind, placebo-controlled, randomized and multi-Center clinical trial in China to determine the efficacy of Huatuo Zaizao Pills in improving neural function and life quality in patients with acute ischemic stroke in China.

The study was designed with a target sample size of 1100 patients and the investigators will perform 200 patients in the first period. Patients will be randomly assigned to receive Huatuo Zaizao Pills or placebo at dose of 12g each time, twice daily.

The investigators hypothesis that this study might offer based medicine evidence to test and verified the efficacy of Huatuo Zaizao Pills in improving the neural function and life quality in patients with ischemic stroke. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01758536
Study type	Interventional
Source	Huashan Hospital
Contact	Zheng-yu Lu, MD
Phone	8613817912099
Email	luzhengyu@yahoo.cn
Status	Recruiting
Phase	Phase 4
Start date	December 2012
Completion date	December 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05196659` - Collaborative Quality Improvement (C-QIP) Study	N/A
Recruiting	`NCT06027788` - CTSN Embolic Protection Trial	N/A
Completed	`NCT03281590` - Stroke and Cerebrovascular Diseases Registry
Recruiting	`NCT05518305` - Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
Recruiting	`NCT06029959` - Stroke and CPAP Outcome Study 3	N/A
Recruiting	`NCT03728738` - Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke	Phase 3
Terminated	`NCT03396419` - IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
Recruiting	`NCT05065216` - Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)	Phase 2/Phase 3
Recruiting	`NCT04897334` - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke	N/A
Not yet recruiting	`NCT06462599` - Osteopontin Gene Polymorphism in Stroke Patients in Egypt
Not yet recruiting	`NCT06026696` - Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
Not yet recruiting	`NCT06032819` - Differentiating Between Brain Hemorrhage and Contrast
Recruiting	`NCT02910180` - Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
Completed	`NCT03554642` - Walkbot Robotic Training for Improvement in Gait	Phase 3
Completed	`NCT02922452` - A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects	Phase 1
Withdrawn	`NCT01866189` - Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke	N/A
Recruiting	`NCT03041753` - Reperfusion Injury After Stroke Study	N/A
Completed	`NCT02549846` - AdminiStration of Statin On Acute Ischemic stRoke patienT Trial	Phase 4
Completed	`NCT01678534` - Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial	Phase 2
Completed	`NCT02610803` - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy Study of Huatuo Zaizao Pills in Improving of Neural Function in Acute Ischemic Stroke — HTZZP-INF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms