Dazhu Hongjingtian injection as adjuvant therapy for improved assessment of patients with acute ischemic stroke(AIS): study protocol for a prospective, multicenter study

Phase 4

• Conditions: Acute ischemic stroke

• Registration Number: ITMCTR2022000005
• Lead Sponsor: Institute Of Basic Research In Clinical Medicine,China Academy Of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age =18 years old, male and female hospitalized patients;
2. Meet the diagnostic criteria of western medicine for acute ischemic stroke;
3. Meet the diagnostic criteria of traditional Chinese medicine for acute ischemic stroke;
4. The onset time of acute ischemic stroke is less than or equal to 14 days;
5. The patient or the patient's family member and guardian signed the informed consent.

Exclusion Criteria

1. Silent cerebrovascular disease without symptoms and signs;
2. Combining severe hypertension or diabetes and other diseases, the disease cannot be controlled after treatment;
3. Patients with other diseases that affect the function of limb movement, and those with limb movement dysfunction caused by lameness, osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. before treatment, which may affect the neurological function examination;
4. Those who were unable to independently complete daily activities due to various diseases and physical weakness before the disease had a serious impact on the efficacy evaluation;
5. Those with other comorbidities and complications that affect drug evaluation: including severe cardiac insufficiency, renal insufficiency, severe mental illness, depression after stroke, dementia, and cerebral hemorrhage after cerebral infarction;
6. Contraindicated groups in the instructions for Dazhu Rhodiola injection (pregnant women; those with allergic constitution or previous allergies to multiple drugs, or those who are allergic to the components in the research drug; Patients with a history of adverse reactions containing Dazhu Rhodiola);
7. Those in the control group who used other dosage forms of Rhodiola rosea (tablets, capsules, etc.) in accordance with the technical guidelines for clinical research on the treatment of stroke with new traditional Chinese medicines;
8. Patients considered by other researchers to be inappropriate to participate in this study.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in NIHSS scores within 7 days of admission;Modified mRS scale score 3 months after enrollment;

Secondary Outcome Measures

Name	Time	Method
adverse event rates;All-cause mortality;Recurrence rate within 6 months;Improvement of TCM syndromes;Neurological deficit (mRS, BI) for 3-6 months;