Therapeutic efficacy and immunoregulatory effect of Qiangji Jianli Capsule for patients with myasthenia gravis: study protocol for a series of randomized, controlled N-of-1 trials
Phase 1
- Conditions
- Myasthenia gravis
- Registration Number
- ITMCTR2000003367
- Lead Sponsor
- The First Affiliated Hospital of Guangzhou University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Patients aged 18-65 years;
2. The patients with myasthenia gravis and stable condition were confirmed to have hormone dosage less than 15 mg / d;
3. Patients with deficiency of spleen and stomach qi were diagnosed by traditional Chinese medicine;
4. Patients who can have normal speech communication;
5. Informed consent, volunteer patients.
Exclusion Criteria
1. Pregnant or preparing pregnant women, lactating women;
2. Patients with a history of drug abuse and mental illness;
3. Patients with serious primary diseases such as liver, kidney, hematopoietic system, cardiopulmonary system, endocrine system and malignant tumor.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total dose of immunosuppressive agents;QMG score;Total hormone dosage;Expression levels of Tregs cells and their cytokines (IL-4, IL-17A, TGF-beta, INF-gama);
- Secondary Outcome Measures
Name Time Method MG-ADL;