Main
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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:
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ITMCTR |
Last refreshed on:
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20 February 2023 |
Main ID: |
ITMCTR2200005637 |
Date of registration:
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2021-06-20 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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2022-01-01 |
Target sample size:
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contrast group:27;Experimental group:27; |
Recruitment status: |
Recruiting |
URL:
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http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=05c50307-1f4a-40d8-8ae5-ccbf2038524a |
Study type:
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Interventional study |
Study design:
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Parallel
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Contact type:
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Public
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Name:
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Yu Shangzhen
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Address:
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30 Huayuan Road East, Pengjiang District, Jiangmen, Guangdong, China
529000
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Telephone:
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+86 13500281692 |
Email:
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ysz6521@126.com |
Affiliation:
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Affiliated Jiangmen Traditional Chinese Medicine Hospital of Ji'nan University |
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Contact type:
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Scientific
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Name:
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Hu Shaowen
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Address:
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30 Huayuan Road East, Pengjiang District, Jiangmen, Guangdong, China
529000
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Telephone:
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+86 15017588984 |
Email:
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331672634@qq.com |
Affiliation:
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Affiliated Jiangmen Traditional Chinese Medicine Hospital of Ji'nan University |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Ocular myasthenia gravis
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Intervention(s)
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contrast group:Pyridostigmine Bromide Tablets;Experimental group:Buzhong Yiqi Decoction;
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Primary Outcome(s)
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MG Quality of life 15;the absolute and relative Score of MG, ARS-MG;Integral of TCM Syndrome;
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Secondary ID(s)
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ChiCTR2100047506
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ChiMCTR2200005637
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Source(s) of Monetary Support
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Affiliated Jiangmen Traditional Chinese Medicine Hospital of Ji'nan University
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Ethics review
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Status: |
Approved
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Approval date: |
29/04/2021
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Contact name: |
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Contact address: |
Li Libin
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Contact telephone: |
+86 750 3509641
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Contact email: |
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Results
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Results available: |
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URL: |
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URL of the protocol: |
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Date Posted: |
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Date of completion: |
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Date of first publication: |
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Results summary: |
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Baseline characteristics: |
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Outcome measures: |
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IPD sharing plan: |
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IPD sharing description: |
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