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Completed

NCT Number: NCT07472777

Long-term Efficacy of Modified Guilu Erxian Glue for Myasthenia Gravis

Through a retrospective cohort study method, the influence of Gu-Lu Er-Xian Decoction with modified formula on the long-term therapeutic effect of patients with myasthenia gravis was analyzed, and the related factors affecting recurrence were also explored.

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Key information

Conditions

Myasthenia Gravis (MG) Autoimmune Diseases Autoimmune Diseases of the Nervous System Disease Attributes Immune System Diseases Myasthenia Gravis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

About this study

Screen the medical records of MG patients who visited the hospital from January 2020 to January 2024. By July 31, 2024, the final follow-up for the patient outcomes was completed. Taking the cumulative use of Gui鹿 Erxian Jiawo Formula for ≥ 1 month per year as the exposure factor， the included patients were divided into the exposure group and the non-exposure group. The clinical characteristics and medium-to-long-term efficacy of the two groups were compared. The primary outcome was the recurrence rate， and the secondary outcomes included the time for the first reduction of conventional Western medicine dosage， MGFA classification， GFA-PIS， TCM syndrome score， HAMA， the incidence of myasthenic crisis， and MG-ADL. Through Cox multivariate regression analysis， the factors related to MG recurrence were analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically confirmed diagnosis of myasthenia gravis (MG), with other differential diagnoses excluded
  • Received standardized conventional Western medicine treatment for MG for at least 1 month (bromopyridostigmine tablets combined with prednisone acetate tablets)
  • Complete and traceable medical records available for the entire study period

Exclusion criteria

  • Complicated with other major systemic diseases, severe functional impairment of the heart, liver or kidney, or a documented history of mental illness
  • Incomplete medical records that cannot support full data extraction and statistical analysis

Treatment and study plan

Primary outcomes

  1. Recurrent rate

    Time frame: July 31, 2024

Secondary outcomes

  1. The time for the first reduction of conventional Western medicine dosage

    Time frame: July 31, 2024

  2. MGFA classification

    Time frame: July 31, 2024

    Unabbreviated Scale Title: Myasthenia Gravis Foundation of America (MGFA) Clinical Classification for Myasthenia Gravis

    Scale Range: Class I (ocular-only involvement, mildest) to Class V (mechanical ventilation required, most severe), total 5 hierarchical classes

    Interpretation: Higher classification grade indicates more severe myasthenia gravis and worse clinical outcome.

  3. MGFA-PIS

    Time frame: July 31, 2024

    Unabbreviated Scale Title: Myasthenia Gravis Foundation of America Post-Intervention Status (MGFA-PIS) Scale

    Scale Range: 7 hierarchical grades, ranging from Complete Stable Remission (Grade 1, best treatment response) to Disease Exacerbation (Grade 7, worst treatment response)

    Interpretation: Higher grade indicates poorer treatment response and worse clinical outcome of myasthenia gravis.

  4. TCM syndrome score

    Time frame: July 31, 2024

    Unabbreviated Scale Title: Traditional Chinese Medicine Syndrome Score for Myasthenia Gravis (formulated in accordance with the Guiding Principles for Clinical Research of New Chinese Medicines)

    Scale Range: Total score ranges from 0 to 36 points; each core symptom is rated on a 4-point scale (0 = no symptom, 1 = mild, 2 = moderate, 3 = severe)

    Interpretation: Higher total score indicates more severe TCM syndrome manifestations and worse clinical condition.

  5. HAMA

    Time frame: July 31, 2024

    Unabbreviated Scale Title: Hamilton Anxiety Rating Scale

    Scale Range: Total score ranges from 0 to 56 points; 14 items are each rated on a 5-point scale (0 = no symptom, 1 = mild, 2 = moderate, 3 = severe, 4 = extremely severe)

    Interpretation: Higher total score indicates more severe anxiety symptoms.

  6. The incidence rate of myasthenic crisis

    Time frame: July 31, 2024

  7. MG-ADL

    Time frame: July 31, 2024

    Unabbreviated Scale Title: Myasthenia Gravis-Activities of Daily Living (MG-ADL) Scale

    Scale Range: Total score ranges from 0 to 24 points; 8 items are each rated on a 4-point scale (0 = normal function, 3 = severe functional impairment)

    Interpretation: Higher total score indicates worse activity of daily living ability and more severe myasthenia gravis-related functional impairment.

Sponsors and collaborators

Lead sponsor

Beijing University of Chinese Medicine

Other

Registry information

Official study title

Long-term Efficacy of Modified Guilu Erxian Glue in Treating Patients With Myasthenia Gravis: A Retrospective Cohort Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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