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A multicentre, randomised, double-blind, placebo-controlled experimental study on the treatment of stroke disease with the addition of Xingwu Piper Chengqi Granules

A multicentre, randomised, double-blind, placebo-controlled experimental study on the treatment of stroke disease with the addition of Xingwu Piper Chengqi Granules

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074427
Enrollment
Unknown
Registered
2023-08-07
Start date
2023-07-26
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Cerebral haemorrhage and cerebral infarction

Interventions

control subjects:Basic treatment plan: developed according to the relevant requirements of the Chinese guidelines for the diagnosis and treatment of cerebral haemorrhage (2019) and the 2018 Chinese ex
experimental group:Basic treatment regimen + Plus flavour Xing Piper Cheng Qi Granules (decoction-free dosage form): Oral or intra-gastric tube administration, 13g/times three times a day, 7 days as a

Sponsors

Traditional Chinese Medicine Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)The age range is 18-80 years; 2)Comply with the Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage (2019) issued by the Neurology Branch of the Chinese Medical Association, the Cerebrovascular Disease Group of the Neurology Branch of the Chinese Medical Association, and the 2018 Chinese Expert Consensus on the Emergency Diagnosis and Treatment of Acute Ischemic Stroke issued by the Emergency Medicine Quality Control Center of the National Health Commission on diagnosis and treatment of acute ischemic stroke in China, regarding diagnosis and treatment of haemorrhagic stroke versus ischemic stroke, and were admitted to the hospital within 72h of the onset of the disease; 3)Patients who met the TCM diagnosis of stroke, and who had wind-fire, phlegm-stasis, and xuanfu depression and closure certificates; the relevant diagnostic criteria were designated with reference to the relevant contents of the "TCM Diagnosis and Treatment Plan for Stroke Disease (Cerebral Haemorrhage) (2017 edition) and China Ischemic Stroke Diagnosis and Treatment Guidelines (2018 edition)" issued by the State Administration of Traditional Chinese Medicine, and are briefly described as follows: a.Main symptoms of stroke disease: hemiplegia, dizziness, imprecise speech or speechlessness, abnormal sensation in the paraplegic body, and crookedness of the mouth and tongue. b.Secondary symptoms: headache, vertigo, pupillary changes, choking on water, eye deviation, ataxia. c.Acute onset of disease, most of the triggers before the onset of disease, often with aura symptoms. The diagnosis can be confirmed by the presence of more than 2 primary symptoms, or 1 primary and 2 secondary symptoms, combined with the onset of disease, triggers, aura symptoms, and age; the diagnosis can also be confirmed by the combination of the results of imaging tests if the above conditions are not present. 4)Patients and/or their families gave informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with the presence of tumours, haematological disorders, systemic immune cerebrovascular aneurysms static sinus thrombosis systemic disorders, systemic immune disorders, venous sinus thrombosis, arteritis, and smog disease; 2)Patients with acute coronary syndrome, cerebral haemorrhage, peripheral vascular occlusive disease in the last 3 months; 3) Severe liver/renal function abnormalities, heart failure, and infections; 4) Patients with recent use of immunosuppressants, antibiotics, glucocorticoids; 5) Those with severe diarrhoea symptoms before the onset of the disease; 6) Situations where the drug cannot be taken due to allergy; 7) other conditions that the investigator considers unsuitable for the study.

Design outcomes

Secondary

MeasureTime frame
Chinese Medicine Symptoms Factor Points;NIHSS Rating Score;mRS Rating;BI Rating;

Primary

MeasureTime frame
Rankin Scale (mRS);

Countries

China

Contacts

Public ContactZhang Dechou

Traditional Chinese Medicine Hospital of Southwest Medical University

zdchou2328@126.com+86 158 8303 3609

Outcome results

None listed

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