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

Efficacy and Safety of Zhitan Anshen 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
ChiCTR2100046157
Enrollment
Unknown
Registered
2021-05-06
Start date
2021-05-15
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Cerebral Infarction

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. Meet the diagnostic criteria for cerebral infarction, and be confirmed by head CT or MRI; 2. Meet the standard of Chinese medicine stroke-qi deficiency and blood stasis syndrome type; 3. In the recovery period (the course of illness is between 2 weeks and 6 months) 4. Aged 40 to 75 years; 5. First stroke, stable vital signs, clear consciousness, able to cooperate with examination and treatment; 6. Having motor dysfunction and Fugl-Meyer score <= 84 points; 7. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe cardiovascular, cerebrovascular, liver, kidney, malignant tumors, hematological diseases, and mental diseases; 2. Severe disturbance of consciousness, dementia or suffering from certain diseases affect the evaluation of curative effects, such as aphasia, visual and hearing impairment; 3. Transient organic psychosis and other mental illnesses (such as depression, schizophrenia), or other mental disorders that meet the DSM-IV-R standards; 4. Patients who have other diseases that affect the function of limbs, and those who have dysfunction of limbs caused by claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. before treatment may affect nerve or functional examination; 5. Patients who are allergic to test drug components, or have a history of alcohol or drug abuse; 6. Women who are pregnant or breastfeeding, or have a pregnancy plan in the past 6 months, or cannot use effective contraceptive measures (sterilization, long-term use of contraceptives/drugs, condoms, or removal of the vas deferens from their partners, etc.); 7. Participating in other clinical trials or participating in other drug clinical trials within 3 months. 8. Patients judged by the investigator to be unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer upper limb rating scale;

Secondary

MeasureTime frame
Modified Rankin Scale;Brunnstrom stage;TCM symptom score;Modified Barthel Index;

Countries

China

Contacts

Public ContactXia Wenguang

Hubei Provincial Hospital of Integrated Chinese and Western Medicine

docxwg@163.com+86 13307180658

Outcome results

None listed

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