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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04910256
• Other study ID #: XiyuanH-huatuo zaizao pill
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2021
• Est. completion date: October 20, 2024

Study information

• Verified date: April 2023
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: Yanqiu Ding
• Phone: (+86)18513123006
• Email: dingyanqiu001[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 20, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• HuaTuo Zaizao pill
Patients take 8g of HuaTuo Zaizao pill three times a day. Treatment lasts for 12 weeks.

Other:
• basic treatment
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.

Locations

Country	Name	City	State
China	Xiyuan Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]
Secondary	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]
Secondary	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]
Secondary	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]