A randomized controlled clinical trial study protocol of Bujing Yishi tablet in the treatment of Children and Adolescents with Low-grade Myopia
- Conditions
- Myopia
- Registration Number
- ITMCTR2100004611
- Lead Sponsor
- Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Meet the diagnostic criteria for myopia;
2. Aged 6 to 12 years;
3. The naked eye vision is below 1.0, and the myopia degree is -0.50D~3.00D;
4. Participants and their guardians with the ability to understand, and write research-related materials, and voluntarily comply with all test requirements;
5. Agree to sign an informed consent form and voluntarily participate in the research.
1. Participants with myopia and amblyopia / strabismus;
2. Spherical equivalent (SE)<-0.5D, or combined with pathologic myopia-related fundus changes and/or obvious visual dysfunction;
3. Subjects suffering from serious systemic diseases, such as cerebrovascular, liver, kidney, hematopoietic system, and psychiatric diseases;
4. use other related drugs or treatments within 2 weeks;
5. Participate in other clinical trial research;
6. Allergies to test drugs;
7. Incomplete understanding of the research, refusal to participate or lack of signed informed consent;
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diopter;
- Secondary Outcome Measures
Name Time Method visual sensitivity;best-corrected visual acuity;changes in TCM syndrome integral;convergence near point;axial length;naked acuity;