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Clinical efficacy evaluation of tonifying the spleen and kidney, dispelling dampness and turbidity in the treatment of myasthenia gravis

Clinical efficacy evaluation of tonifying the spleen and kidney, dispelling dampness and turbidity in the treatment of myasthenia gravis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077700
Enrollment
Unknown
Registered
2023-11-16
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-21

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

Conditions

Myasthenia gravis

Interventions

Treatment group of traditional Chinese medicine hospital:NA
Treatment Group of Western Hospital:NA

Sponsors

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Myasthenia Gravis 2020 or meet the diagnostic criteria of traditional Chinese medicine; (2) Patients with myasthenia gravis who meet the clinical classification of MGFA type I, II (IIa, IIb), and III (IIIa, IIIb); (3) Age range from 14 to 85 years old, did not use Chinese or Western medicine treatment drugs at the initial diagnosis, or did not use Chinese or Western medicine treatment drugs for more than a week; (4) Not accompanied by severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, or intestinal diseases (such as acute inflammation, tumors, severe infections, etc.); (5) Female non pregnancy and lactation period; (6) Agree to participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those who do not meet the inclusion criteria; (2)Patients who have been taking other Western medicines for the treatment of myasthenia gravis, other than bromopyridamine tablets, prednisone acetate, and tacrolimus, as well as any other traditional Chinese medicine or Western medicine that affects the gut microbiota (such as antibiotics), for more than a week. (3) Pregnant or lactating women; (4) Patients with allergies or contraindications to the ingredients of bromopyridamine tablets, prednisone acetate, tacrolimus, and traditional Chinese medicine decoction; (5) Combined with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, or intestinal diseases (such as acute inflammation, tumors, severe infections, etc.); (6) Participants in clinical trials of other drugs simultaneously. Those who meet any of the above criteria will be excluded.

Design outcomes

Secondary

MeasureTime frame
MG-absolute and relative scoring system (ARS-MG) scores;The 15-item MG Quality of Life (MG-QOL15) scores;MG-specific manual muscle test (MMT);The Myasthenia Gravis activities of daily living profile (MG-ADL) scores;Intestinal microbiota sequence;Serum AChR-Ab titers;Time and dosage of Western medicine reduction or even discontinuation;

Primary

MeasureTime frame
MGFA post-intervention status;Quantitative Myasthenia Gravis (QMG) scores;

Countries

China

Contacts

Public ContactQiao Wenjun

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

1105043061@qq.com+86 181 0245 6736

Outcome results

None listed

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