Evidence-based Evaluation of TCM Key Syndrome Differentiation and Treatment for Acute Ischemic Stroke

NCT04199455 | Unknown Phase 4 DMC

• 1 other identifier: 2018YFC1705002
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this trial is to determine whether Chinese medicine (CM) for eliminating phlegm and clearing heat (EPACH) recipe continuously with nourishing Qi and activating blood circulation (NQABC) recipe, oral within 72 hours of symptom onset, improves the 15-day neurologicl deficits in participants with acute ischemic stroke.

Conditions

Ischemic Stroke

Keywords

acute ischemic stroke; neurologic impairment; integrative therapy; Chinese herbs; prospective randomized double-blind controlled trial

Outcome Measures

Primary Outcomes (1)

• Comparison of the change in the NIHSS scores from baseline to 15 days in the two groups.

  The NIHSS score ranges from 0 (best score) to 42 (worst score).

  Baseline and 15 days.

Secondary Outcomes (5)

• Proportion of Patients Independent

  30 days and 90 days after symptom onset.

• Activities of Daily Living

  30 days and 90 days after symptom onset.

• Stoke Syndrome Factor Evaluation Scale

  5 days and 15 days after randomization.

• Patient Reported Outcome (PRO) Scale of Stroke

  15 days after randomization

• Proportion of complications during hospitalization

  During the period of hospitalization, an average of 10 to 15 days

Study Arms (2)

Integrative Treatment Group

EXPERIMENTAL

Patients randomly assigned to the intervention group will receive EPACH and NQABC Chinese herbal compound granules, which will be manufactured by the Beijing Kangrentang Pharmaceutical company, combined with standard stroke care according to the Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018.

Drug: Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules)

Control Group

PLACEBO COMPARATOR

Patients randomly assigned to the control group will receive recipe simulators as placebo, which will be manufactured by the Beijing Kangrentang Pharmaceutical company, combined with standard stroke care according to the Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018.

Drug: Placebo

Interventions

Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules) DRUG

Patients randomly assigned to the intervention group will receive EPACH and NQABC Chinese herbal compound granules, which will be manufactured by the Beijing Kangrentang Pharmaceutical company, combined with standard stroke care according to the Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018. Route of administration: oral. Dose regimen: Day 1 to Day 5: in addition to the guideline-based standard treatment, 7.35g of EPACH recipe granules, dissolved with 200ml of boiled water, twice a day. Day 6 to Day 15: in addition to the guideline-based standard treatment, 6.85g of NQABC recipe granules, dissolved with 200ml of boiled water, twice a day.

Also known as: EPACH Recipe Granules + NQABC Recipe Granules

Integrative Treatment Group

Placebo DRUG

Patients randomly assigned to the intervention group will receive recipe simulators as placebo. EPACH and NQABC granules and recipe simulators are indistinguishable, identical in size, shape, color, appearance. Placebo is no decocting granules contain 5% original formula, 20% bitter gourd extract, 75% dextrin, and caramel color. Those who are assigned to the control group will be given placebo and guideline-based standard stroke treatment. Route of administration: oral. Dose regimen: Day 1 to Day 5: in addition to the guideline-based standard treatment, 7.35g of recipe simulator, dissolved with 200ml of boiled water, twice a day. Day 6 to Day 15: in addition to the guideline-based standard treatment, 6.85g of recipe simulator, dissolved with 200ml of boiled water, twice a day.

Also known as: Recipe Simulators

Control Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute disabling ischemic stroke (4≤ NIHSS score ≤25 at the time of randomization) that can be treated with study drug within 72 hours of symptoms onset. Acute ischemic stroke, were confirmed by magnetic resonance imaging (MRI) or computer tomography (CT).
• Adult subjects (male or female ≥ 40 years and ≤ 80 years)
• Diagnosis of phlegm-dampness syndrome with manifestation of heat (the score of "Phlegm-dampness syndrome" ≥10 with the score of "Internal fire syndrome" ≥2 in Diagnostic Scale for Syndrome Elements of Ischemic Stroke.
• Patient or legally authorized representative has signed informed consent.

You may not qualify if:

• Planned or already receiving intravenous thrombolysis or endovascular treatment (intravascular mechanical thrombectomy, intra-arterial thrombolysis and angioplasty).
• Patients who have received other traditional Chinese Medicine Decoctions (Granules) and Chinese patent medicines Treatment for stroke.
• Confirmed secondary stroke caused by tumors, brain trauma, hematological diseases, infectious diseases, hereditary diseases, rheumatic immune diseases, etc
• modified Rankin Scale (mRS) Score \> 2 at randomization (pre-morbid historical assessment).
• Other conditions that lead to motor dysfunction (i.n., severe osteoarthritis, rheumatoid arthritis, gouty arthritis, etc).
• Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal)
• Severe non-cardiovascular comorbidity with life expectancy \< 3 months.
• Complicated with other diseases that limited the evaluation of neurological function or affect the follow-up of patients.
• Known to be pregnant or breastfeeding.
• Currently receiving an investigational drug.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Hospital of Chinese medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yefeng Cai, MD

  Guangzhou University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuanqi Zhao, MD

CONTACT

+8613922137130; tcm2008@126.com

Min Zhao, MD

CONTACT

+8615989184470; cassiesandra@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Encephalopathy Center of Guangdong Provincial Hospital of Chinese Medcicine, Professor, Chief Physician, Neurologist

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 16, 2019
• Study Start: December 4, 2019
• Primary Completion: May 30, 2021
• Study Completion: August 30, 2021
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)