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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

To investigate the immunomodulation effect of invigorating spleen and invigorating Qi on myasthenia gravis based on N-of-1 randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033516
Enrollment
Unknown
Registered
2020-06-03
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia gravis

Interventions

Sponsors

The First Affiliated Hospital of Guangzhou University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Expression levels of Tregs cells and their cytokines (IL-4, IL-17A, TGF-beta, INF-gama);QMG score;Total hormone dosage;Total dose of immunosuppressive agents;

Secondary

MeasureTime frame
MG-ADL;

Countries

China

Contacts

Public ContactQilong Jiang

Department of Spleen and Stomach, the First Affiliated Hospital of Guangzhou University of TCM.

jqllpzx@126.com+86 15989082142

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026