Innovative research for the pathogenesis of myasthenia gravis in traditional Chinese medicine

Phase 1

• Conditions: myasthenia gravis

• Registration Number: ITMCTR2000003226
• Lead Sponsor: The First Affiliated Hospital of Guangzhou University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with ophthalmic muscle, medulla oblongata or systemic mg18-65 years old and with onset of systemic symptoms or systemic diseases confirmed by neurophysiological tests for no more than 12 months;
2. The diagnosis of Mg should be determined according to the following methods (refer to the Chinese myasthenia gravis diagnosis and treatment guidelines in 2015):
Clinical nervous system status, motor symptoms are consistent with Mg, and there are at least two conditions: anti acetylcholine receptor antibody (AChR) and / or other myasthenia antibody positive serological test. Typical mg findings using single fiber electromyography (SFEMG) and / or repetitive nerve stimulation (RNs) and / or neurophysiological testing of neuromuscular conduction. As judged by the physician, patients with positive tests with oral / intramuscular cholinesterase inhibitors;
3. Patients with MGFA grade II to IV were screened;
4. Patients with quantitative mg score (QMG) >=6 at screening;
5. Patients with deficiency of spleen and stomach qi based on syndrome differentiation of traditional Chinese medicine: refer to the standard of syndrome differentiation and treatment of traditional Chinese Medicine
Deficiency of spleen and Stomach Qi: the main syndrome is ptosis, weakness of limbs, or with diplopia, or with morning light and evening heavy;
In the second syndrome, the stomach swells after eating, or the stool is thin or hard before the pond, or the tongue is not thirsty and reddish, the tongue is fat or has teeth marks on the side, and the pulse is thin and weak;
The diagnosis can be made by the patients with primary and secondary symptoms;
If the diagnosis standard has the main syndrome and one of the secondary syndromes, it can be diagnosed as this syndrome;
The establishment of traditional Chinese medicine diagnosis depends on the syndrome differentiation and diagnosis of more than three doctors, three people make the syndrome differentiation and classification of patients separately by means of four diagnosis methods of traditional Chinese medicine, and the diagnosis of syndrome type of traditional Chinese medicine is established after three people have unified opinions;
6. Women with fertility must have negative pregnancy test and no planned pregnancy during the study;
7. Patients willing to provide written informed consent;
8. Patients who are able and willing to follow all study procedures.

Exclusion Criteria

1. Myasthenia only affects patients with ocular or periocular muscles (MGFA grade I) and Mg crisis in screening (MGFA grade V);
2. Patients who had thymectomy in the last half year. In order to avoid the difficulty in evaluating the efficacy of the study drug, thymectomy (if necessary) should be scheduled for a follow-up period of 8 weeks;
3. Pregnant or nursing patients;
4. Patients with serious primary diseases such as liver, kidney, hematopoietic system, cardiopulmonary system, endocrine system and malignant tumor;
5. Patients who have used high-dose hormone, gamma globulin and plasma exchange in the past 3 months.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MGC score;QMG score;

Secondary Outcome Measures

Name	Time	Method
Quality of life evaluation: MG-ADL scale, MG-PRO scale evaluation;Evaluation of curative effect of TCM syndrome;Dosage of glucocorticoid and immunosuppressive drugs;Incidence of related events: mortality, myasthenia crisis, thymectomy;