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A randomized, double-blind, placebo-controlled clinical study on the efficacy and safety of Tanhuo pill in the treatment of ischemic stroke (phlegm-heat syndrome)

A randomized, double-blind, placebo-controlled clinical study on the efficacy and safety of Tanhuo pill in the treatment of ischemic stroke (phlegm-heat syndrome)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000227
Enrollment
Unknown
Registered
2025-02-08
Start date
2024-12-25
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Acute ischemic stroke

Interventions

Control group:Standardized Western Medicine Treatment for Acute Cerebral Infarction
Experimental group:Standardized Western Medicine Treatment for Acute Cerebral Infarction+Tanhuo Pill

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) First confirmed acute ischemic stroke; 2) Meets the diagnostic criteria for phlegm heat syndrome in traditional Chinese medicine; 3) The onset time of symptoms of acute ischemic stroke is within 72 hours; 4) MRS score = 2 points before the onset of stroke symptoms; 5) Failure to undergo intravenous or arterial thrombolysis and endovascular intervention therapy; 6) NIHSS score, 5 = score = 15; 7) Age range from 18 to 85 years old; 8) Sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Hemorrhagic cerebrovascular disease (confirmed by head MRI including subarachnoid hemorrhage cerebral hemorrhage and other intracranial hemorrhage); Cardiogenic cerebral embolism; Unidentified or other cause ischemic stroke; Brain tumors traumatic brain injury parasitic brain diseases etc; 2) Transient cerebral ischemia (TIA) and reversible ischemic neurological deficit (RIND); 3) Severe systemic diseases including but not limited to: 1) Cardiac dysfunction: myocardial infarction heart failure; 2) Liver dysfunction: Total bilirubin>3mg/dL albumin178 µ Mol/L (2mg/dL) urea nitrogen>18mmol/L (40mg/dL); 4) Digestive system diseases: peptic ulcers gastrointestinal bleeding etc.; 5) Malignant tumors; 4) Individuals who are allergic to the components of Tan Huo Wan; 5) Mental disorders that affect drug evaluation such as depression anxiety dementia epilepsy etc; 6) Women with recent family planning as well as pregnant and lactating women; 7) Subjects who are unable to understand informed consent or unwilling to provide personal information and do not wish to enter the study;

Design outcomes

Secondary

MeasureTime frame
ADL;IL-6;National Institute of Health stroke scale;hs-CRP;mRS;Traditional Chinese Medicine Syndrome Score;

Primary

MeasureTime frame
Ratio of subjects with mRS scores of 0-1;

Countries

China

Contacts

Public ContactWang ningqun

Xuanwu Hospital, Capital Medical University

wangningqun@126.com+86 138 1116 8892

Outcome results

None listed

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