NCT07472777

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

March 6, 2026

Last Update Submit

March 12, 2026

Conditions

Myasthenia Gravis (MG)

Keywords

Myasthenia GravisModified Guilu Erxian GlueMid- and Long-term EfficacyRecurrenceRetrospective Study

Outcome Measures

Primary Outcomes (1)

  • Recurrent rate

    July 31, 2024

Secondary Outcomes (7)

  • The time for the first reduction of conventional Western medicine dosage

    July 31, 2024

  • MGFA classification

    July 31, 2024

  • MGFA-PIS

    July 31, 2024

  • TCM syndrome score

    July 31, 2024

  • HAMA

    July 31, 2024

  • +2 more secondary outcomes

Study Arms (1)

MG patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

MG patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Myasthenia GravisRecurrence

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 16, 2026

Study Start

January 1, 2024

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)