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Efficacy and Safety of Jiannao Tongluo Granules in Motor Dysfunction After Cerebral Infarction: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Efficacy and Safety of Jiannao Tongluo Granules in Motor Dysfunction After Cerebral Infarction: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046068
Enrollment
Unknown
Registered
2021-05-03
Start date
2021-05-15
Completion date
Unknown
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke

Interventions

Sponsors

Hubei Provincial Hospital of Integrated Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. It meets the diagnostic criteria of "cerebral infarction" and is confirmed by head CT or MRI; 2. Comply with the standard of stroke-wind, phlegm and blood stasis syndrome in traditional Chinese medicine; 3. In the recovery period (the course of illness is 2 weeks to 6 months); 4. Aged 40 to 75 years; 5. For the first time, the vital signs are stable, the consciousness is clear, and they can cooperate with the examination and treatment; 6. There is obvious motor dysfunction, Fugl-Meyer score <=84 points; 7. Volunteer to participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe cardiovascular, cerebrovascular, liver, kidney, malignant tumors, hematological diseases, and mental illnesses; 2. Transient organic psychosis and other mental illnesses (such as depression, schizophrenia), or other mental disorders that meet the DSM-IV-R standards; 3. Those who are allergic to test drug ingredients, or have a history of alcohol or drug abuse; 4. Women who are pregnant or breastfeeding, or have a pregnancy plan within the past 6 months, or who cannot use effective contraceptive measures (sterilization, long-term use of contraceptives/drugs, condoms, or removal of the vas deferens from their partners, etc.); 5. Participating in other clinical trials or participating in other drug clinical trials within 3 months; 6. The investigator judges the patients who are not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer upper limb rating scale;

Secondary

MeasureTime frame
TCM symptom score;Modified Barthel Index;National Institute of Health Stroke Scale;Modified Rankin Scale;Motor Evoked Potential;

Countries

China

Contacts

Public ContactXia Wenguang

Hubei Hospital of Integrated Traditional Chinese and Western Medicine

docxwg@163.com+86 13307180658

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026