Clinical Study on Huatuo Zaizao Pills for Post-stroke Treatment

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Ischemic Stroke

Treatments: Drug: Huatuo Zaizao Pills; Other: Basic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04910256

XiyuanH-huatuo zaizao pill

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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 criteria

• 1.Unstable vital signs, or serious heart, liver, lung, kidney and other organ diseases
• 2.Exclude Transient Ischemic Attack(TIA)
• 3.Patients who are participating in clinical trials of other drugs within the past 1 month
• 4.Pregnant or breastfeeding women
• 5.Athletes, Epileptics, Allergic to this product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

HuaTuo ZaiZao group

Experimental group

Description:

In this arm, patients take 8g of HuatuoZaizao pill three times a day. Besides，participants will receive basic treatment in accordance with the "Guidelines for diagnosis and treatment of ischemic stroke in China",and the drug and dosage will be formulated by the researchers according to the clinical situation.Treatment lasts for 12 weeks

Treatment:

Other: Basic treatment

Drug: Huatuo Zaizao Pills

Control group

Sham Comparator group

Description:

participants will receive basic treatment in accordance with the "Guidelines for diagnosis and treatment of ischemic stroke in China",and the drug and dosage will be formulated by the researchers according to the clinical situation.Treatment lasts for 12 weeks

Treatment:

Other: Basic treatment