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Clinical Trials in China / NCT07338175
Recruiting Phase 3

Efficacy and Safety of Minocycline in Acute Spontaneous Intracerebral Hemorrhage

NCT07338175 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tiantan Hospital
Phase
Phase 3
Started
2026-04-02
Last updated
2026-04-23

Condition(s) studied

Intracerebral Hemorrhage

Investigational drug(s) / intervention(s)

Minocycline hydrochloride capsules →Placebo capsules of Minocycline hydrochloride capsules

Minocycline hydrochloride capsules: 50 mg per capsule, containing 50mg of Minocycline Hydrochloride

Placebo capsules of Minocycline hydrochloride capsules: 50 mg per capsule, containing 0 mg of Minocycline Hydrochloride

Study summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. It aims to evaluate the efficacy and safety of oral minocycline in patients with acute spontaneous intracerebral hemorrhage within 48 hours of onset.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. CT-confirmed spontaneous supratentorial intracerebral hemorrhage; 2. Aged 18 to 80 years; 3. Within 48 hours of symptom onset; 4. Hematoma volume 15-40 ml; 5. NIHSS score 8-24, with item 1a ≤ 2; 6. Signed informed consent by the patient or legal representative. Exclusion Criteria: 1. Secondary intracerebral hemorrhage (traumatic, tumor-related, vascular malformation, aneurysm, coagulation disorder, etc.); 2. Intraventricular hemorrhage filling one entire lateral ventricle, third ventricle, or fourth ventricle, or more than half of two lateral ventricles; 3. Significant subarachnoid hemorrhage (Fisher grade ≥ 3) or subdural hemorrhage; 4. Patients with uncontrollable hypertension ( systolic blood pressure persistently ≥ 180 mmHg despite intensive antihypertensive treatment); 5. Progressive neurological or other severe systemic diseases; 6. Planned surgical intervention for the intracerebral hemorrhage; 7. Pre-stroke disability (modified Rankin Scale score \> 1); 8. Severe cardiac insufficiency (NYHA Class III-IV), severe liver disease (ALT or AST \> 3 times the normal upper limit value), severe renal insufficiency (serum creatinine \> 2 times the normal upper limit value, or glomerular filtration rate \< 45 ml/min), or malignancy with life expectancy \< 1 year; 9. Moderate to severe anemia (hemoglobin \< 90 g/L), thrombocytopenia (platelet count \< 100×10\^9/L), leukopenia (white blood cell count \< 2×10\^9/L), or coagulopathy (INR \> 1.5); 10. Allergy or intolerance to minocycline or other tetracycline antibiotics; 11. History of pseudomembranous enteritis or antibiotic-associated enteritis; 12. Use of tetracycline antibiotics within the past week; 13. Intracranial or spinal surgery within the past 3 months; 14. Any major surgery or severe physical trauma within the past month; 15. Females who are pregnant, within 30 days postpartum, or in the lactation period. 16. Participated in other interventional clinical trials within the past 3 months; 17. Inability to obtain signed informed consent from the patient or representative; 18. Other conditions that are not suitable for participating in this clinical trial, such as inability to understand and/or follow the research procedures due to mental, cognitive, emotional, or physical disorders, etc.

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Beijing Tiantan Hospital Beijing Beijing Municipality Recruiting
Chongqing Tongnan District People's Hospital Chongqing Chongqing Municipality Recruiting
The Second People's Hospital of Guangdong Province Guangzhou Guangdong Recruiting
Baoding Fourth Central Hospital (Tangxian, Hebei) Baoding Hebei Recruiting
Zhangjiakou First Hospital Zhangjiakou Hebei Not Yet Recruiting
Zunhua People's Hospital Zunhua Hebei Recruiting
Mengzhou Fuxing Hospital Mengzhou Henan Recruiting
Nanle County People's Hospital Nanle Henan Recruiting
Neixiang County People's Hospital Neixiang Henan Recruiting
General Hospital of Pingmei Shenma Medical Group Pingdingshan Henan Recruiting
Puyang County People's Hospital Puyang Henan Recruiting
Yellow River Sanmenxia Hospital Sanmenxia Henan Recruiting
Shangqiu Third People's Hospital Shangqiu Henan Recruiting
Suixian Hospital of Traditional Chinese Medicine Shangqiu Henan Recruiting
Taikang County People's Hospital Taikang Chengguanzhen Henan Recruiting
Henan Sanbo Brain Hospital Zhengzhou Henan Recruiting
Taihe Hospital of Shiyan Shiyan Hubei Recruiting
Liuyang Jili Hospital Guankou Hunan Recruiting
Shaodong People's Hospital Shaodong Hunan Recruiting
Baotou Central Hospital Baotou Inner Mongolia Recruiting
People's Hospital of Inner Mongolia Autonomous Region Hohhot Inner Mongolia Recruiting
Ordos Central Hospital Ordos Inner Mongolia Recruiting
Ulanqab Central Hospital Ulanqab Inner Mongolia Recruiting
Wuyuan County People's Hospital Wuyuan Inner Mongolia Recruiting
Affiliated Hospital of Nantong University Nantong Jiangsu Recruiting
Siyang Kangda Hospital Siyang Jiangsu Recruiting
Dalian Lushunkou District Hospital of Traditional Chinese Medicine Dalian Liaoning Recruiting
Kuandian Central Hospital Dandong Liaoning Recruiting
Yingkou Fangda Hospital Yingkou Liaoning Recruiting
The Fifth People's Hospital of Ningxia Hui Autonomous Region Shizuishan Ningxia Recruiting
Xianyang Hospital of Yan'an University Xianyang Shaanxi Recruiting
Binzhou Central Hospital, Shandong Province Binzhou Shandong Recruiting
Third People's Hospital of Liaocheng City, Shandong Province Liaocheng Shandong Recruiting
Weihai Wendeng District People's Hospital Tianfu Shandong Recruiting
Weihai Municipal Hospital Weihai Shandong Recruiting
Weihai Municipal Third Hospital Weihai Shandong Recruiting
451560995@Qq.Com Shanghai Shanghai Municipality Recruiting
Yilong County People's Hospital Jincheng Sichuan Recruiting
Tianjin Huanhu Hospital Tianjin Tianjin Municipality Recruiting
Yiyang Central Hospital Hunan Yiyang Recruiting

+ 1 more sites — see the full list on the official registry below.

More Beijing Tiantan Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07338175 on ClinicalTrials.gov ↗ ← All trials in China