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临床试验/ITMCTR1900002799
ITMCTR1900002799尚未招募未知

The investigation for the effects of Ti-Luo Hua-Yu Yang-Xue Ming-Mu method on the eyeground blood flow of the NTG patients

China Academy of Chinese Medical Sciences Eye Hospital0 个研究点开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional study

入排标准

年龄范围
20 至 75(—)
性别
All

入选标准

  • Part one inclusion criteria:
  • Inclusion criteria for Normal control group:
  • 1. the best corrected visual acuity (BCVA) > 0.8;
  • 2. IOP <21 mmHg;
  • 3. The eyeground is normal, C/D is normal. OCT shows normal RNFL thickness and normal visual field;
  • 4. Aged 20 and 75 years.
  • Inclusion criteria for HTG group:
  • 1. meet the diagnostic criteria;
  • 2. Aged between 20 and 75 years;
  • Inclusion criteria of NTG group:
  • 1. meet the diagnostic criteria and the TCM Syndrome Diagnostic Criteria;
  • 2. Ages between 20 and 75 years;
  • 3. After lowering intraocular pressure drug therapy, intraocular pressure stabilized below 15mmHg for more than 2 months.
  • Part two inclusion criteria:
  • 1. meet the diagnostic criteria and the TCM Syndrome Diagnostic Criteria;
  • 2. Ages between 20 and 75 years;
  • 3. After lowering intraocular pressure drug therapy, intraocular pressure stabilized below 15mmHg for more than 2 months.

排除标准

  • Part one exclusion criteria:
  • Exclusion criteria for control group:
  • 1. family history of glaucoma;
  • 2. diopter greater than + 3.00d or less than -8.00d;
  • 3. patients with serious systemic diseases such as heart failure, liver and kidney dysfunctions, gastric and duodenal ulcers, diabetes mellitus and malignant hypertension. Serum creatinine > 2 times upper limit of normal value (ULN); Serum glutamine transaminase > 3 times ULN;
  • 4. History of eye surgery or trauma;
  • 5. Mental illness or anxiety, depression and other abnormal psychological state and malignant tumors;
  • 6. Pregnant or nursing women;
  • 7. Failing to follow doctor's advice and cooperate with relevant examinations.
  • Exclusion criteria for NTG and HTG group:
  • 1. Fixation loss > 20%;
  • 2. Diopter between + 3.00d and -8.00d;
  • 3. The false-positive or false-negative rate of visual field tested by Humphrey is greater than 33;
  • 4. Patients with malignant tumors;
  • 5. History of eye surgery or trauma;
  • 6. In the past 1 month, have used traditional Chinese medicine or western medicine of vasodilator and neuroprotective drugs;
  • 7. Suspicious or definite allergy to the study drug;
  • 8. Serum creatinine > 2 ULN;
  • 9. Serum glutamine transaminase > 3 ULN;
  • 10. History of eye surgery or trauma;
  • 11. Patients with heart Yang deficiency syndrome are mainly manifested by chest tightness and chest pain, palpitations and cold sweat, and aversion to cold limbs;
  • 12. Mental illness or anxiety, depression and other abnormal psychological state and malignant tumors;
  • 13. Participated in other clinical trials in the last 3 months;
  • 14. Pregnant or nursing women;
  • 15. Failing to follow doctor's advice and cooperate with relevant examinations.
  • Part two exclusion criteria:
  • Exclusion criteria for NTG and HTG group:
  • 1. Fixation loss > 20%;
  • 2. Diopter between + 3.00d and -8.00d;
  • 3. The false-positive or false-negative rate of visual field tested by Humphrey is greater than 33;
  • 4. Patients with malignant tumors;
  • 5. History of eye surgery or trauma;
  • 6. In the past 1 month, have used traditional Chinese medicine or western medicine of vasodilator and neuroprotective drugs;
  • 7. Suspicious or definite allergy to the study drug;
  • 8. Serum creatinine > 2 ULN;
  • 9. Serum glutamine transaminase > 3 ULN;
  • 10. History of eye surgery or trauma;
  • 11. Patients with heart Yang deficiency syndrome are mainly manifested by chest tightness and chest pain, palpitations and cold sweat, and aversion to cold limbs;
  • 12. Mental illness or anxiety, depression and other abnormal psychological state and malignant tumors;
  • 13. Participated in other clinical trials in the last 3 months;
  • 14. Pregnant or nursing women;
  • 15. Failing to follow doctor's advice and cooperate with relevant examinations.

研究者

发起方
China Academy of Chinese Medical Sciences Eye Hospital

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