Clinical efficacy and Therapeutic Mechanism of Yiqihuoxuetongqiaomingmu recipe in the treatment of non-Arterial Ischemic Optic Neuropathy (NAION)

Not Applicable

• Conditions: non-Arterial Ischemic Optic Neuropathy

• Registration Number: ITMCTR1900002774
• Lead Sponsor: the first affiliated Hospital of Guangzhou University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. In accordance with the diagnostic criteria of expert consensus on diagnosis and treatment of non-arteritis Ischemic Optic Neuropathy in China (2015);
2. Aged 18 to 70 years old;
3. the syndrome differentiation of traditional Chinese medicine accords with the syndrome of qi deficiency and blood stasis:
The main syndrome:
(1) the visual object is faint;
(2) the visual object is occluded;
Concurrently syndrome 1:
(1) the complexion was pale or dark;
(2) Palpitations, shortness of breath and forgetfulness;
(3) Tired, yellowed, tired and lazy;
(4) The quality of the tongue is light
Concurrently syndrome 2:
(1) headache or eye pain, pain such as a thorn, pain fixed;
(2) Ecchymosis of tongue;
(3) the pulse is thin or weak
Has at least one of the main symptoms, and has at least one of the concurrently syndrome 1 and 2 respectively.

Exclusion Criteria

(1) complicated with other ophthalmopathy and temporal artery inflammatory lesions affecting visual function;
(2) absence of light sensation more than 7 degree, course of disease more than 3 months;
(3) excluding other optic nerve diseases that can cause optic disc edema and visual impairment, such as glaucoma, optic neuritis, optic nerve atrophy and so on;
(4) allergic to drugs (including methylprednisolone sodium succinate, methylprednisolone tablets, vitamin B1, mecobalamin tablets, traditional Chinese medicine granules);
(5) pregnant and lactating women.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
best corrected visual acuity;mean visual field defect;

Secondary Outcome Measures

Name	Time	Method
optical coherence tomography;score of Syndrome scale of traditional Chinese Medicine;fundus fluorescein angiography;pattern visual evoked potential;