Myasthenia Gravis (MG)NCT07472777
Long-term Efficacy of Modified Guilu Erxian Glue for Myasthenia Gravis
An observational study of Myasthenia Gravis (MG), run by Beijing University of Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myasthenia Gravis (MG)
- How many people
- 231 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: MG patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan
About this study
Official title: Long-term Efficacy of Modified Guilu Erxian Glue in Treating Patients With Myasthenia Gravis: A Retrospective Cohort Study
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.
Read the detailed description
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.
- Conditions
- Myasthenia Gravis (MG)
- Keywords
- Myasthenia Gravis, Modified Guilu Erxian Glue, Mid- and Long-term Efficacy, Recurrence, Retrospective Study
- Medical subject headings
- Myasthenia Gravis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MG patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent rate
Measured: July 31, 2024
Secondary outcomes (7)
The time for the first reduction of conventional Western medicine dosage
Measured: July 31, 2024
MGFA classification
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.
Measured: July 31, 2024
MGFA-PIS
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.
Measured: July 31, 2024
TCM syndrome score
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.
Measured: July 31, 2024
HAMA
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.
Measured: July 31, 2024
The incidence rate of myasthenic crisis
Measured: July 31, 2024
MG-ADL
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.
Measured: July 31, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Jan 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia Gravis (MG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruge Liu, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472777
- Sponsor's protocol ID
- 2023HL-232-01
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy of Modified Guilu Erxian Glue in Treating Patients With Myasthenia Gravis: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07472777
- Acronym / sponsor ID
- 2023HL-232-01
- Conditions
- Myasthenia Gravis (MG)
- Keywords
- Myasthenia Gravis, Modified Guilu Erxian Glue, Mid- and Long-term Efficacy, Recurrence, Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MG patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MG patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrent rate
Time frame: July 31, 2024
7 secondary outcomes
The time for the first reduction of conventional Western medicine dosage
Time frame: July 31, 2024
MGFA classification
Time frame: July 31, 2024
MGFA-PIS
Time frame: July 31, 2024
TCM syndrome score
Time frame: July 31, 2024
HAMA
Time frame: July 31, 2024
The incidence rate of myasthenic crisis
Time frame: July 31, 2024
MG-ADL
Time frame: July 31, 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis (MG), run by Beijing University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent rate (time frame: July 31, 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.