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Zhenyuan Huanwu Granule for Post-Stroke Fatigue: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Zhenyuan Huanwu Granule for Post-Stroke Fatigue: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059296
Enrollment
Unknown
Registered
2022-04-28
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-02-26

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

Conditions

Post-Stroke Fatigue

Interventions

treatment group:Zhenyuan Huanwu Granule

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Conform to the diagnostic criteria of traditional Chinese and western medicine for stroke, and the syndrome differentiation of traditional Chinese medicine is Qi deficiency syndrome; 2. Occurrence>14 days; 3. Age: 30-80 years old; 4. With fatigue symptoms, FSS score = 36 points; 5. Volunteer to participate in the study and cooperate with relevant examination, treatment and evaluation.

Exclusion criteria

Exclusion criteria: 1. People with serious cognitive and speech impairment; 2. Patients with severe heart, liver, kidney and other visceral diseases, mental diseases, malignant tumors, immune system diseases, blood system diseases, metabolic diseases and endocrine diseases, and patients with active infection at admission (active infection is defined as pre-existing fever or accompanying symptoms, including shortness of breath, cough, expectoration and urinary symptoms); 3. Pregnant or lactating; 4. Those who are allergic to the ingredients of Zhenyuan Huanwu Granules or Chinese herbal medicine granules placebo; 5. Those who are participating in other studies that affect the evaluation of this study.

Design outcomes

Primary

MeasureTime frame
Fatigue Severity Scale, FSS;

Secondary

MeasureTime frame
Multidimensional Fatigue Inventory, MFI-20;Fatigue Self-Assessment Scale, FSAS;Fugl-Meyer Assessment,FMA;Modified Barthel index, MBI;Stroke-Specific Quality of Life, SS-QOL;Depression, Anxiety, and Stress Scale 21,DASS21;Montreal Cognitive Assessment,MoCA;Short-Form Mini Nutritional Assessment,MNA;Nutritional Risk Screening 2002,NRS2002;

Countries

China

Contacts

Public ContactChen Hongxia

Guangdong Provincial Hospital of Chinese Medicine

chx2004@126.com+86 13609031028

Outcome results

None listed

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