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Observation on the Clinical Efficacy of Shuangjie Decoction in Patients with Acute Ischemic Stroke Based on the "External Dispersion and Internal Quenching Method"

Observation on the Clinical Efficacy of Shuangjie Decoction in Patients with Acute Ischemic Stroke Based on the "External Dispersion and Internal Quenching Method"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000289
Enrollment
Unknown
Registered
2026-02-09
Start date
2023-08-10
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

acute ischemic stroke

Interventions

A Group:Patients in Group A received standard drug treatment: oral aspirin enteric-coated tablets 100mg once a day
Take atorvastatin calcium tablets 20mg orally once a day. Intravenous infusion of mannitol injection is administered. The specific dosage and frequency are determined by the attending physician based
Intravenous infusion of 100mL of butylphthalide injection twice a day
Take 2.5mg of levamlodipine besylate tablets orally once a day for 14 consecutive days.
B Group:Standard drug treatment (the same as Group A) + Shuangjie Decoction treatment. The composition of the prescription and drug is: 15g of Chinese kale, 15g of Gastrodia elata, 12g of Perilla frut

Sponsors

Weifang Hospital Of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients who meet all of the following five criteria can be included in this study: 1) They are diagnosed with acute ischemic stroke according to the Western medical diagnostic criteria and have a National Institutes of Health Stroke Scale (NIHSS) score of 1 to 15, indicating mild to moderate acute ischemic stroke; 2) They are diagnosed with stroke according to the above-mentioned TCM diagnostic criteria and have a score of =7 for the wind syndrome in the TCM syndrome differentiation criteria; 3) Their age is between 40 and 80 years old; 4) The onset time of acute ischemic stroke is less than 48 hours; 5) The patient or their legal representative is willing to participate in the study and can sign the informed consent form.

Exclusion criteria

Exclusion criteria: Patients who met any of the following criteria were excluded from this study: 1) The patient had already suffered from neurological deficits (mRS>2) before the onset of this acute ischemic stroke. 2) The patient is in a coma and has unstable vital signs. 3) The patient requires emergency interventional endovascular thrombectomy or intravenous thrombolysis. 4) Severe heart, lung, liver or kidney insufficiency or other systemic diseases that may affect survival expectations and participation in follow-up; 5) The patient has severe hypertension or diabetes and other diseases. Despite active treatment, the condition has not been effectively controlled (blood pressure persistently >160/100 mmHg, fasting blood glucose persistently >11.1 mmol/L). 6) The researchers believe that other diseases accompanied by the patient may interfere with the correct evaluation of neurological function, or participating in this trial may lead to other complications in the patient. 7) The patient has an allergic constitution and is allergic to the components of the investigational drug and excipients. 8) The patient has participated in other clinical trials within the past 3 months;

Design outcomes

Primary

MeasureTime frame
National Institutes of Health Stroke Scale;

Secondary

MeasureTime frame
Modified Barthel Index;Points of wind syndrome in Traditional Chinese medicine;Hypersensitive C-reactive protein;Central nervous system specific protein;Interleukin- 6;Tumor necrosis factor-a;Homocysteine;

Countries

China

Contacts

Public ContactManli Zhao

Weifang Hospital Of Traditional Chinese Medicine

maryzhao7451@126.com13791888338

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026