The study on the pathogenesis of spleen-kidney deficiency type myasthenia gravis and the interference effect of Jianji Ning Granule on the patients

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TRC-13004125
• Date of registration: 2013-06-08
• Prospective Registration: No
• Primary sponsor: Longhua Hospital Affiliated to Shanghai University of traditional Chinese Medicine
• Public title: The study on the pathogenesis of spleen-kidney deficiency type myasthenia gravis and the interference effect of Jianji Ning Granule on the patients
• Scientific title: The study on the pathogenesis of spleen-kidney deficiency type myasthenia gravis and the interference effect of Jianji Ning Granule on the patients
• Date of first enrolment: 2010-10-01
• Target sample size: trial:30;Control:30;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=5443
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: I+II (Phase I+Phase II)

Countries of recruitment

China

Contacts

• Name: Ping Liu
• Affiliation: Longhua Hospital Affiliated to Shanghai University of traditional Chinese Medicine

• Name: Chao Jiang
• Affiliation: Longhua Hospital Affiliated to Shanghai University of traditional Chinese Medicine

Key inclusion & exclusion criteria

Inclusion criteria: (1) in line with diagnosis of MG based on the Western medicine diagnostic criteria for autoimmune myasthenia gravis9, including symptoms of fluctuating muscle weakness supported by an electromyographic pattern of neuromuscular transmission dysfunction by repetitive stimulation, belonging to the modified Osseman I, IIA, IIB type;
(2) patients with Chinese medical diagnosis of flaccidity fitting to the differentiation standard of spleen-kidney deficiency type syndrome 10, Where have the one of the main symptoms and secondary symptoms of more than one, or both, see tongue, pulse can be included;
(3) patients were between 14 and 75 years old patients were voluntary;
(4) the subjects were informed voluntary and written informed consent to participate the study.
Exclusion criteria: 1. Osseman III, IV, V;
2. Familial MG, congenital myasthenic syndrome and drug (D-penicillamine, interferon induced by MG, etc.);
3. patients who were nursing or pregnant;
4. patients who had comorbid diseases such as cerebrovascular diseases, renal insufficiency, hematopoietic system diseases, and psychiatric diseases;
5. allergies (allergic to more than 2 kinds of food or medicine);
6. The last 1 months participated in other clinical trials of drugs;
7. Once plasma exchange or intravenous gamma globulin in treatment patients in the past three months.

Age minimum: 14
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

Myasthenia gravis

Intervention(s)

trial:Jianji Ning Granule combined with olfactory pyridostigmine tablets ;Control:olfactory pyridostigmine tablets ;

Primary Outcome(s)

MGFA;Chinese Quality of Life Scale;The incidence of recurrent disease;Peripheral serum miRNA microarray detection;

Secondary Outcome(s)

Improvement rate of Autoimmune myasthenia gravis;Serum acetylcholine receptor antibody detection;Electromyograph;

Source(s) of Monetary Support

Shanghai Science and Technology Commission