Administrative information
Title {1} | Efficacy and safety of Bujing Yishi tablet for glaucoma with controlled IOP: study protocol for a multi-centre randomized controlled trial |
Trial registration {2a and 2b}. | Chinese Clinical Trial Registry, ID: ChiCTR1800016431. Registered on 1 June 2018 |
Protocol version {3} | Date April 6, 2018 and version 2.0 |
Funding {4} | This trial was supported by the Chinese Medicine Bureau of Sicuan Province (2018) NO. 2018LC008. |
Author details {5a} | 1.College of Ophthalmology, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan, China; 2.Department of Ophthalmology, Mianyang Central Hospital, Mianyang 621000, Sichuan, China; 3.Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan, China; 4.Department of Ophthalmology, The Affiliated Eye Hospital of Wenzhou Medical University, Wenzhou 325027, Zhejiang, China; 5.National Drug Clinical Trial Agency, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan, China; 6.Department of Ophthalmology, Mianyang Hospital of Traditional Chinese Medicine, Mianyang 621000, Sichuan, China; 7.Department of Ophthalmology, The Second People’s Hospital of Chengdu PiDu District, Chengdu 611733, Sichuan, China; 8.Zhongshan Ophthalmic Center, SunYat-sen University, Guangzhou 510275, Guang-dong, China |
Name and contact information for the trial sponsor {5b} | Chinese Medicine Bureau of Sicuan Province, No. 15 Yongxing lane, Jingjiang District, Chengdu, 610000, China |
Role of sponsor {5c} | The study funder has no role in the study design, data collection and management, and manuscript writing publication |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion criteria
Exclusion criteria
TCM syndrome differentiation
Blurry visual acuity | ▫ 0: None |
▫ 2: Mild blurred visual acuity | |
▫ 4: Unable to read | |
▫ 6: Difficult to see anything | |
Narrow visual field | ▫ 0: None |
▫ 2: As if something obscures visual acuity | |
▫ 4: Inconvenient to walk | |
▫ 6: Difficult to walk | |
Eye distension | ▫ 0: None |
▫ 2: Mild eye distension | |
▫ 4: Endurable eye distension | |
▫ 6: Intolerable eye distension | |
Dry eye | ▫ 0: None |
▫ 2: Mild dry eye | |
▫ 4: Obvious dry eye, as if there is a foreign body in it | |
▫ 6: Intolerable dry eye, frequent blink | |
Limp aching lumbus and knees | ▫ 0: None |
▫ 2: Early morning aching lumbus, which can be alleviated by beating; mild limp knees | |
▫ 4: Continuous aching lumbus, which will be aggravated when working knees are too limp to carry heavy weight | |
▫ 6: Severe aching lumbus, which will not be relieved by rest; knees are too limp to desire to walk | |
Dark purple tongue | ▫ 0: No |
▫ 2: Yes | |
Thready pulse deep, string or unsmooth | ▫ 0: No |
▫ 2: Yes |