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

ITMCTR

Registry ID

ITMCTR2000003367

Enrollment

Unknown

Registered

2020-06-03

Start date

2020-06-01

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Myasthenia gravis

Interventions

B:placebo

A:Qiangji Jianli Capsule

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

Measure	Time frame
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

Measure	Time 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: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026