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Note: This record shows only 24 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ITMCTR
Last refreshed on: 20 February 2023
Main ID:  ITMCTR2200005637
Date of registration: 2021-06-20
Prospective Registration: Yes
Primary sponsor: Affiliated Jiangmen Traditional Chinese Medicine Hospital of Ji'nan University
Public title: Efficacy of Buzhong Yiqi Decoction in the Treatment of Ocular Myopathy Myasthenia Gravis (MG) Patients with Spleen and Kidney Deficiency Type: a Randomized Controlled Trial
Scientific title: Efficacy of Buzhong Yiqi Decoction in the Treatment of Ocular Myopathy Myasthenia Gravis (MG) Patients with Spleen and Kidney Deficiency Type: a Randomized Controlled Trial
Date of first enrolment: 2022-01-01
Target sample size: contrast group:27;Experimental group:27;
Recruitment status: Recruiting
URL:  http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=05c50307-1f4a-40d8-8ae5-ccbf2038524a
Study type:  Interventional study
Study design:  Parallel  
Phase:  0
Countries of recruitment
China
Contacts
Contact type: Public
Name: Yu Shangzhen   
Address:  30 Huayuan Road East, Pengjiang District, Jiangmen, Guangdong, China 529000
Telephone: +86 13500281692
Email: ysz6521@126.com
Affiliation:  Affiliated Jiangmen Traditional Chinese Medicine Hospital of Ji'nan University
Contact type: Scientific
Name: Hu Shaowen   
Address:  30 Huayuan Road East, Pengjiang District, Jiangmen, Guangdong, China 529000
Telephone: +86 15017588984
Email: 331672634@qq.com
Affiliation:  Affiliated Jiangmen Traditional Chinese Medicine Hospital of Ji'nan University
Key inclusion & exclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria of Western medicine for myasthenia gravis, as well as the diagnosis and syndrome differentiation criteria of Chinese medicine;
2. Patients classified as ocular myasthenia gravis according to the modified Osserman classification;
3. Aged less than 80 years;
4. After understanding the contents of this study in detail, the patients voluntarily accepted observation and signed the informed consent.

Exclusion criteria: 1. Patients with myasthenia gravis receiving high dose of corticosteroids or other immunosuppressive agents;
2. Patients who have had myasthenia crisis or are experiencing myasthenia in the past 1 month;
3. Severe mental disorders cannot cooperate with clinical investigators;
4. Patients with other neuromuscular diseases or peripheral nerve diseases;
5. Patients complicated with serious primary diseases such as cardiovascular, cerebrovascular, respiratory, digestive or endocrine systems, as well as patients complicated with autoimmune diseases or mental illnesses;
6. Pregnant or lactating women and people with allergies.


Age minimum: 18
Age maximum: 80
Gender: Both
Health Condition(s) or Problem(s) studied
Ocular myasthenia gravis
Intervention(s)
contrast group:Pyridostigmine Bromide Tablets;Experimental group:Buzhong Yiqi Decoction;
Primary Outcome(s)
MG Quality of life 15;the absolute and relative Score of MG, ARS-MG;Integral of TCM Syndrome;
Secondary Outcome(s)
Secondary ID(s)
ChiCTR2100047506
ChiMCTR2200005637
Source(s) of Monetary Support
Affiliated Jiangmen Traditional Chinese Medicine Hospital of Ji'nan University
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 29/04/2021
Contact name:
Contact address: Li Libin
Contact telephone: +86 750 3509641
Contact email:
Results
Results available:
URL:
URL of the protocol:
Date Posted:
Date of completion:
Date of first publication:
Results summary:
Baseline characteristics:
Adverse events:
Outcome measures:
IPD sharing plan:
IPD sharing description:
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