隐蔽分组方法和过程:
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中国中医科学院临床评价中心将随机信封直接寄至北京康仁堂制药,由康仁堂制药工作人员直接将随机号引入颗粒剂编号,研究者按照颗粒剂编号发药。
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Process of allocation
concealment:
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The clinical Evaluation Center of China Academy of Chinese Medical Sciences will send the random envelope directly to Beijing Kangrentang Pharmaceutical Co., LTD., and the staff of Kangrentang Pharmaceutical co., LTD will introduce the random number into the granules number, and the researcher will issue drugs according to the granules number.
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盲法:
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1.本研究为双盲临床试验,对受试者和临床试验研究者设盲。
2.研究用颗粒剂均由北京康仁堂制药制备,保证治疗组与对照组药物外观、气味、色泽均一致。
3.中国中医科学院临床评价中心将随机信封直接寄至北京康仁堂制药,由康仁堂制药工作人员直接将随机号引入颗粒剂编号,研究者按照颗粒剂编号发药。
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Blinding:
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1.This study was a double-blind clinical trial, with the subjects and clinical trial investigators being blind.
2.The granules used in the study were prepared by Beijing Kangrentang Pharmaceutical Co., LTD., to ensure that the appearance, smell and color of the drugs in the treatment group and the control group were the same.
3.The clinical Evaluation Center of China Academy of Chinese Medical Sciences will send the random envelope directly to Beijing Kangrentang Pharmaceutical Co., LTD., and the staff of Kangrentang Pharmaceutical co., LTD will introduce the random number into the granules number, and the researcher will issue drugs according to the granules number.
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揭盲或破盲原则和方法:
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揭盲:在盲态审核并认为所建立的数据库正确无误后,由主要研究者、药物注册申请人、生物统计学专业人员和保存盲底的有关人员对数据库进行锁定。锁定后的数据文件不允许再作变动并将数据库保存备查。然后进行第一次揭盲,将数据库交生物统计学专业人员进行统计分析。当统计分析结束后进行第二次揭盲,此次揭盲确定哪一组为试验组。
破盲:为了保证受试者的安全, 在紧急情况下,如发生SAE又不能判断与试验药物是否有关、过量服药、与合并用药产生严重的药物相互反应等,急需知道服用何种药物决定抢救方案时,需要提前破盲。破盲后要及时记录提前破盲的时间、原因和执行破盲人员,同时尽快通知监查员(申办者)。一旦提前破盲,该受试者一般就不应该继续参加研究,且其试验数据通常不能用与疗效评价分析,但是仍要列入安全分析数据集。对受试者还应做好及时的治疗和保护。
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Rules of uncover or
ceasing blinding:
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Unblinding: The database will be locked by the principal investigator, the applicant for drug registration, the biostatistics professional and the relevant personnel who keep the blind records after the blind review and the conclusion that the database is correct. Locked data files are not allowed to change and the database is saved for future reference. Then the first unblinding was performed and the database was submitted to biostatistics professionals for statistical analysis. When the statistical analysis was completed, the second unblinding was conducted to determine which group was the experimental group.
Blindness breaking: In order to ensure the safety of the subjects, in case of emergency, such as SAE occurrence which cannot be determined whether it is related to the test drug, overdose, and serious drug interaction with drug combination, etc., it is urgent to know which drug to take and decide the rescue plan, blindness should be broken in advance. After the blindness is broken, the time, reason and personnel to break the blindness in advance shall be recorded in time, and the supervisor (sponsor) shall be notified as soon as possible. Once the blindness is broken in advance, the subject should generally not continue to participate in the study, and the trial data usually cannot be analyzed for efficacy evaluation, but should still be included in the safety analysis data set. Subjects should also be treated and protected in a timely manner.
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统计方法名称:
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1.研究结果采用意向分析(ITT)和符合方案集分析(PP)。
2.应用SPSS 22.0统计软件分析,若计量资料符合正态分布,采用均数±标准差(X±s)表示,若计量资料不符合正态分布,采用中位数和四分位数间距表示,以P<0.05为具有统计学意义。
3.两阶段治疗组及对照组干预前后不同时间点中医证侯评分、最佳矫正视力、等效球镜度数、眼轴长度、黄斑视网膜血流密度及厚度、脉络膜厚度、mGCC厚度及局部丢失体积(focal loss volume,FLV)、整体丢失体积 (global loss volume,GLV)比较,若数据符合正态分布,采用单因素重复测量方差分析;若不符合正态分布,采用非参数检验中的Friedman检验,组内两两比较运用Bonferroni法校正。
4.两阶段治疗组与对照组同一时间点的中医证侯评分、最佳矫正视力、等效球镜度数、眼轴长度、黄斑视网膜血流密度及厚度、脉络膜及mGCC厚度、FLV、GLV比较,若数据符合正态分布,采用两个独立样本t检验;若不符合正态分布,采用秩和检验。
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Statistical method:
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1.Intention analysis (ITT) and conformity protocol set analysis (PP) were used for the study results.
2.SPSS 22.0 statistical software was used for analysis. If the measurement data were in line with normal distribution, mean ± standard deviation (X± S) was used as expression; if the measurement data were not in line with normal distribution, median and quad spacing were used as expression; P < 0.05 was considered statistically significant.
3.TCM syndrome score, best corrected visual acuity, equivalent spherical lens, axial length, macular retinal blood flow density and thickness, choroid thickness, mGCC thickness and local loss volume (focal Loss volume, FLV) and Global Loss Volume (GLV). If the data were normally distributed, one-way repeated measure anOVA was used. If the distribution did not conform to normal distribution, Friedman test of nonparametric test was used, and Bonferroni method was used to correct pairwise comparison within groups.
4.TCM syndrome score, best corrected visual acuity, equivalent spherical lens, axial length, macular retinal blood flow density and thickness, choroid and mGCC thickness, FLV and GLV were compared between the two-stage treatment group and the control group at the same time point. If the data were in normal distribution, two independent samples t test was used. If the normal distribution is not matched, the rank sum test is used.
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试验完成后的统计结果(上传文件):
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Calculated Results ater
the Study Completed:
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上传试验完成后的统计结果:
Statistical results after completion of the test file upload
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是否公开试验完成后的统计结果:
Calculated Results after
the Study Completed(upload file):
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公开
Public
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全球唯一识别码:
UTN
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