The efficacy and safety of Danxi granules in the treatment of meridian-collateral phase during recovery period of stroke (blood stasis obstructing collaterals with kidney deficiency syndrome): A single center randomized double-blind double-blind double dummy positive drug parallel controlled clinical trial

Clinical trial research for Danxi granules in treating meridian-collateral phase during recovery period of stroke (blood stasis obstructing collaterals with kidney deficiency syndrome)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2025000960

Enrollment

Unknown

Registered

2025-05-13

Start date

2025-05-22

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Stroke

Interventions

Experimental Group:Danxi Granules and Tiandan Tongluo Tablets placebo

Control Group:Tiandan Tongluo Tablets and Danxi Granules placebo

Eligibility

Sex/Gender

All

Age

45 Years to 75 Years

Inclusion criteria

Inclusion criteria: ?1.Aged 45-75 years 2.Ischemic cerebral infarction or cerebral hemorrhage confirmed by MRI/CT 3.Meet diagnostic criteria for: Meridian-collateral phase during recovery period of stroke Syndrome of blood stasis obstructing collaterals with kidney deficiency 4.Disease duration: 2 weeks to 3 months post-onset (matching 3-month intervention period) 5.TCM syndrome score =5 with =1 primary symptom 6.NIH Stroke Scale (NIHSS) score =1 7.Signed informed consent by participant/legally authorized representative

Exclusion criteria

Exclusion criteria: 1.Absence of definitive neuroimaging evidence (CT/MRI) or insufficient imaging confirmation for diagnosis 2.Acute phase (>3 months post-onset) or chronic sequela phase of stroke 3.Patients with: Mild neurological deficits (e.g. minor stroke [NIHSS =3] rapidly resolving TIA) Severe consciousness impairment (GCS 160/100 mmHg despite treatment) Metabolic: decompensated diabetes (HbA1c >9%) Hepatic/renal dysfunction: ALT/AST >1.5×ULN; serum creatinine >177 µmol/L 6.Neuropsychiatric contraindications: Major depression (HAMD-24 >35) dementia (MMSE <18) or cognitive impairment affecting protocol compliance 7.Concurrent use of: Chinese herbal formulas or proprietary Chinese medicines with similar therapeutic effects Acupuncture/rehabilitation therapies potentially confounding outcomes 8.Hypersensitivity to investigational product components 9.Pregnancy lactation or planned pregnancy within 6 months (women of childbearing potential) 10.Participation in other clinical trials within 3 months 11.High attrition-risk factors: Occupational instability (e.g. frequent business travel) Unstable living conditions predisposing to loss to follow-up

Design outcomes

Primary

Measure	Time frame
Modified Rankin Scale (mRS);Barthel Index (BI);	—

Secondary

Measure	Time frame
Clinc blood pressure and blood lipids (LDL-C, HDL-C etc.);Simplified Fugl-Meyer Assessment (FMA);Platelet function;NIH Stroke Scale (NIHSS);Montreal Cognitive Assessment (MoCA);Hamilton Depression Rating Scale (HAMD-17);Clinical response rate (calculated by TCM syndrome score difference);	—

Countries

China

Contacts

Public ContactGe Jinwen

Affiliated Hospital of Hunan Academy of Chinese Medicine

253805045@qq.com0731-88883760

Outcome results

None listed

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