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Open randomized controlled trial of the Jianpi Yifei Decoction in the treatment of bulbar paralysis of amyotrophic lateral sclerosis

Open randomized controlled trial of the Jianpi Yifei Decoction in the treatment of bulbar paralysis of amyotrophic lateral sclerosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-14005674
Enrollment
Unknown
Registered
2014-12-09
Start date
2014-12-30
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

amyotrophic lateral sclerosis

Interventions

Chinese medicine :Jianpi Yifei Decoction
Riluzole:Riluzole

Sponsors

Guangdong Province Traditional Chinese Medical Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. At the age of 18 years old and above, not limited to men and women; 2. Meet the diagnostic criteria for ALS diagnosis / probable; 3. The patients' informed consent to accept the trial; 4. Women must not be able to become pregnant for the duration of the study. Women of childbearing potential must have a negative pregnancy test at screening and be non-lactating.

Exclusion criteria

Exclusion criteria: 1. Have allergy history of Jianpi Yifei Decoction; 2. Associated with other serious diseases including liver, kidney, cardiovascular disease; 3. Combined with mental illness or severe neurosis patients; 4. Unable to express subjective symptoms; 5. Clinical evidence of unstable medical or psychiatric illness in the investigator's judgment.

Design outcomes

Primary

MeasureTime frame
Water swallow test;Frenchay dysarthria assessment;The ALSFRS-R scale;Swallowing angiography;Strobe laryngoscope;

Secondary

MeasureTime frame
liver function;Creatinine;

Countries

China

Contacts

Public ContactDu Baoxin
yang_biying@126.com+86 13760741846

Outcome results

None listed

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