A multi-center clinical study on Xiaosheng Powder in the treatment of dry eye with liver depression and Yin deficiency

Not Applicable

Recruiting

• Conditions: Dry eye

• Registration Number: ITMCTR2000003486
• Lead Sponsor: Eye Hospital, China Academy of Chinese Medical Sciences

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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. It fully meets the diagnostic criteria of western medicine for dry eyes and conforms to the syndrome differentiation of Traditional Chinese medicine for liver depression and Yin deficiency;
2. No serious cardiovascular and cerebrovascular diseases, mental diseases and other patients not suitable for clinical observation;
3. No other treatment received during the observation period;
4. Sign the informed consent form, voluntarily participate in and cooperate with the experimental subjects.

Exclusion Criteria

1. Lactation or serious systemic chronic diseases;
2. Serious abnormal blood routine and liver and kidney function;
3. Congenital no tears, no tear ducts, neurological disorders, such as nerve is paralytic keratitis, lachrymal tube obstruction caused by large area of ocular surface damage, such as heat or chemical eye burn, eyelid defect and other active eye disease (including acute ocular surface inflammation), uncontrolled systemic disease, wearing contact lens, recently has a history of eye surgery or trauma, etc.
4. Use systemic antihistamines, anticholinergic drugs or other ophthalmic drugs that interfere with the efficacy;
5. If the subject considers it inappropriate to conduct a clinical trial;
6. Failure to adhere to treatment.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index;

Secondary Outcome Measures

Name	Time	Method
Tear Break-up Time;Protein Analysis of Tear Fluid;Fluorescent;Quantitative Score Table of TCM Symptoms;Levels of Tear Inflammatory Factors;Schirmer I test;OQAS Visual Quality Detector;