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Tribulus saponins capsule in the treatment of cerebral infarction

Tribulus saponins capsules in the treatment of cerebral infarction: a phase IV study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014632
Enrollment
Unknown
Registered
2018-01-25
Start date
2017-09-08
Completion date
Unknown
Last updated
2018-01-29

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

Conditions

cerebral infarction

Interventions

Case series:Saponins of Tribulus terrestris in the treatment of cerebral infarction

Sponsors

Dongzhimen Hospital of Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) conforming to the criteria for the diagnosis of cerebral infarction in western medicine; (2) conforming to the diagnostic criteria for the recovery period of meridians and collaterals in Chinese medicine; (3) the syndrome of syndrome differentiation of traditional Chinese medicine is wind phlegm stasis syndrome; (4) imaging (CT or MRI) confirmed that OCSP was clinically classified as complete anterior circulation infarction (TACI) or partial anterior circulation infarction (PACI) or posterior circulation infarction. (5) NIHSS score greater than 5 and less than or equal to 22 points; (6) patients with recurrent or recurrent cerebral infarction were completely or completely recovered before the onset of the disease (mRS score was 0~1 points). (7) the course of the disease was 2 weeks to 3 months after the onset of the disease; (8) aged 35~80 years male and female; (9) voluntary subjects and the signing of the informed consent.

Exclusion criteria

Exclusion criteria: (1) progressive stroke, transient ischemic attack, cerebral hemorrhage after cerebral infarction and patients with cerebral arteritis; (2) patients with brain tumor, brain injury, brain parasitopathy and other diseases that affect the evaluation of drug efficacy; (3) combined with other diseases that affect limb movement function, limb movement dysfunction caused by claudication, osteoarthritis, rheumatoid arthritis and gouty arthritis may affect nerve function examiners before treatment; (4) patients with severe cardiac insufficiency, renal insufficiency, severe mental illness, depression after stroke, and dementia; (5) ALT, AST > upper limit of normal value of 1.5 times or Scr and BUN > upper limit of normal value; (6) patients with diabetic nephropathy; (7) suffering from severe hypertension, taking antihypertensive drugs after the systolic blood pressure, diastolic blood pressure, 90mmHg is more than 160mmHg, or hypotension (resting sitting blood pressure less than 90 mmHg) systolic blood pressure, diastolic blood pressure less than 50mmHg) patients; (8) patients who have undergone intravascular therapy, or in the screening period, are estimated to be required for intravascular treatment; (9) women in pregnancy or lactation; (10) those who were allergic to the known ingredients in this trial; (11) active ulcers and patients with bleeding tendency; (12) other clinical researchers were attended 3 months before the trial; (13) the researchers believe that others should not be involved in this clinical study.

Design outcomes

Primary

MeasureTime frame
Modified Rankin Scale;

Secondary

MeasureTime frame
Barthel Index;NIH Stroke Scale, NIHSS;TCM syndrome score;Single symptom of traditional Chinese Medicine;Recurrence rate and death rate (180th days after the onset of the disease);

Countries

China

Contacts

Public ContactZHANG GEN MING

Beijing University of Chinese Medicine Dongzhimen Hospital

zhanggenming@163.com+86 13522973039

Outcome results

None listed

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