Skip to content

Multicenter Clinical study on Fuyuan Tongluo granule in the treatment of Kidney deficiency and Blood stasis Syndrome in recovery stage of paralysis after Cerebral Infarction

Multicenter Clinical study on Fuyuan Tongluo granule in the treatment of Kidney deficiency and Blood stasis Syndrome in recovery stage of paralysis after Cerebral Infarction

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039430
Enrollment
Unknown
Registered
2020-10-28
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-02-01

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

Conditions

brain diseases

Interventions

Sponsors

The Affiliated Hospital of Hunan Academy of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. It conforms to the diagnostic standard of western medicine for cerebral infarction. 2. In line with the diagnostic criteria of apoplexy syndrome of kidney deficiency and blood stasis, the diagnostic criteria of middle meridian disease and the convalescence stage criteria. 3. The first onset, and head CT or MRI indicated a single lesion in the blood supply area of unilateral and middle cerebral artery. 4. with varying degrees of limb movement dysfunction, simplified fugl-meyer score 2, BI score < 60. 5. After voluntary enrollment, the Chinese and western drugs and non-drug treatments for cerebral infarction other than those specified in this protocol shall be discontinued. 6. Age is between 30 and 75 years old. 7. Patients or their family members voluntarily participate in and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Cerebral hemorrhage confirmed by CT or MRI. 2. Patients with previous history of stroke. 3. Cerebral infarction in acute phase or sequela period. 4. For patients with mild cerebral infarction, simplified Fugl-Meyer score >= 96, modified Rankin scale score = 60, and non-disabling or rapidly improving stroke patients, including transient ischemic attack, etc. 5. Patients with severe cerebral infarction accompanied by consciousness disorder, CT or MRI showed large cerebral infarction (involving more than 1 lobe area or more than 1/3 of the middle cerebral artery supply area), obvious brain mass effect, with CT or MRI signs of midline structure shift. 6. All landowners physical activities of cerebral infarction caused by disorders such as Parkinson's disease, rheumatoid arthritis, gouty arthritis, claudication, etc., as well as combination of cerebral infarction complications, such as depression, anxiety, dementia, epilepsy after cerebral infarction, shoulder joint subluxation, shoulder hand syndrome and lower extremity deep venous thrombosis, gastrointestinal bleeding, pulmonary infection, urinary tract infections, etc., and concurrent cerebral hemorrhage after cerebral infarction, cerebral hemorrhage after infarction, the validity of this study hard to make sure the evaluators. 7. Today with heart, liver, lung, kidney, hematopoietic system and other serious primary diseases, ALT, AST > upper limit of the normal value of 1.5 times, Cr > upper limit of the normal value, and has clinical significance. 8. Pet-type patients with other intracranial lesions, such as arteriovenous malformations, aneurysms, neurotumors, brain trauma, multiple sclerosis, intracerebral parasites, epilepsy, hysteria paralysis, encephalitis, meningitis, hydrocephalus, cerebral amyloidosis and other patients. 9. Legally prescribed patients with disabilities, such as blindness, deafness, deafness, mental disorders and mental disorders, affect the evaluation of neurological function and cooperate with the examiner. 10. Doubt or have alcohol and drug abuse history, or according to the researcher's judgement, can reduce the possibility, follow-up difficult set of other conditions, such as working environment change often, living environment is not stable, etc. 11. Allergic constitution or studying drug ingredients known allergies. 12. Participated in other clinical subjects at the same time or within three months. 13. Have MRI contraindications. 14. Pregnancy or breastfeeding women. 15. Both Yang hyperactivity or fire.

Design outcomes

Primary

MeasureTime frame
Disability rate;

Secondary

MeasureTime frame
Ability to perform daily activities;Strength;Muscle tension;Limb motor function;TCM syndrome integral;

Countries

China

Contacts

Public ContactFang liu

The Affiliated Hospital of Hunan Academy of Chinese Medicine

msliufang23@126.com+86 15073126326

Outcome results

None listed

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