Investigation of Huatuo Zaizao Pill in Treating Phlegm and Blood-stasis Blocking Collaterals Pattern of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial

Study Overview
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Brief Summary
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This study is aiming to evaluate the efficacy and safety of Huatuo Zaizao pill in ischemic stroke patients who diagnosed as the phlegm and blood-stasis blocking collaterals syndrome in TCM. A total of 80 subjects will be randomly assigned to Huatuo Zaizao pill group or the control group.

Detailed Description
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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 NIHSS, Fugl-Meyer, and MAS 90 days after taking the drug. The secondary result is the change in ADL and TCM symptom scale (CM-SS).

Official Title
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Investigation of Huatuo Zaizao Pill in Treating Phlegm and Blood-stasis Blocking Collaterals Pattern of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: HuaTuo Zaizao pill
* Other: basic treatment


Participation Criteria
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Eligibility Criteria
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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.Meeting the diagnostic criteria of phlegm and blood-stasis blocking collaterals pattern in T traditional Chinese medicine 5.Signed and dated written informed consent. 6.4≤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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HuaTuo ZaiZao group<br>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 | Drug: HuaTuo Zaizao pill<br>* Patients take 8g of HuaTuo Zaizao pill three times a day. Treatment lasts for 12 weeks.<br>Other: basic treatment<br>* It 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.<br>|
| Active Comparator: Control group<br>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 | Other: basic treatment<br>* It 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institute of Health Stroke Scale (NIHSS ) | The National Institutes of Health Stroke Scale (NIHSS) is a 15-item measure of the effect of acute stroke on a variety of areas including level of consciousness, neglect, motor strength, facial palsy, ataxia, dysarthria, and sensory loss. | The change from baseline in National institute of health stroke scale (NIHSS ) score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chinese Medicine Symptom Scale (CM-SS) | The CM-SS is a tool, designed according to the Guiding Principles of Clinical Research on New Drugs of Traditional Chinese Medicine issued in 2002, to evaluate the effects of treatments on Traditional Chinese medicine patterns. Scoring is mainly based on some typical TCM symptoms, such as tongue coating and pulse. | The change from baseline in The Chinese Medicine Symptom Scale (CM-SS) total score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days] | 
| Modified Ashworth Scale (MAS) | Modified Ashworth Scale (MAS) measure spasticity. During the administration of MAS , the examiner passively moves the joint being tested and rates the perceived level of resistance in the muscle groups opposing the movement.It is single-item measures ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates that the affected part is rigid in flexion or extension. | The change from baseline in Modified Ashworth Scale (MAS) score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days] | 
| Fugl-Meyer | The Fugl-Meyer Assessment of Sensorimotor Impairment (FM) is one of the first scales developed to quantitatively measure the recovery from hemiplegic stroke. It assesses recovery in five domains, including motor functioning of the upper and lower extremities, balance, sensation, joint range of motion, and joint pain in post-stroke patients. Each task is scored on a scale of 0-2, with 0 indicating the patient cannot perform the task and 2 indicating the patient can fully perform the task. | The change from baseline in Fugl-Meye score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days] | 
| Activities of Daily Living (ADL) | The ADL is a test used in healthcare to evaluate the people's daily self care activities. | The change from baseline in Activities of Daily Living (ADL) total score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days] |