Effect of Traditional Chinese Medicine on Basic Tear Secretion and Tear Cytokines in Patients With Dry Eye Disease
NCT ID: NCT04785261
Last Updated: 2021-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2021-03-16
2022-05-31
Brief Summary
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Detailed Description
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Chi-Ju-Di-Huang-Wan (CJDHW) is commonly used in traditional Chinese medicine (TCM) for eye diseases. However, current research shows that use CJDHW alone to treat dry eye is less effective for tear secretion, which may be related to the unimproved inflammation state. Ligustilide and ferulic acid, which own significant anti-inflammatory effects, are the effective ingredients of Jia-Wei-Xiao-Yao-San (JWXYS). Many studies have demonstrated that JWXYS can reduce serum TNF-α and IFN-γ levels in patients with DED. Therefore, the investigators choose to use CJDHW plus JWXYS for treatment in this study.
This is a single center, randomized, single-blind, controlled pilot study of CJDHW plus JWXYS as a complementary therapy to treat dry eye disease during a 12-week period. The investigators intend to enroll 60 subjects aged between 20 and 75 years old (treatment group(N=30); controlled group(N=30)). Treatment group will be treated with artificial tears combined with TCM, while control group will use artificial tears only. The evaluation will be conducted on 1st, 4th, 8th,12th week. Primary endpoints include Schirmer's test and non-invasive tear film breakup time(NiBUT); secondary endpoints include tear meniscus height, meibomian gland loss rate, tear cytokines and matrix metalloproteinases (MMPs) levels and Ocular Surface Disease Index (OSDI).
The aim of this study is to explore the efficacy and possible mechanism of TCM for DED.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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conventional treatment
Patients in this group will be given conventional treatment including Artelac® Eye Drops (1-2 drips each time, every 4 hours) and Vidisic® Gel (1 drip each time, at bedtime) for 12 weeks.
Methylhydroxypropylcellulose
1-2 drips each time, every 4 hours, for 12 weeks.
Carbomer
1 drip each time, at bedtime, for 12 weeks.
conventional treatment + TCM
Patients in this group will be given conventional treatment and traditional Chinese medicine (6.0g twice daily) for 12 weeks.
Methylhydroxypropylcellulose
1-2 drips each time, every 4 hours, for 12 weeks.
Carbomer
1 drip each time, at bedtime, for 12 weeks.
TCM Formula
6.0g Chi-Ju-Di-Huang-Wan plus 6.0g Jia-Wei-Xiao-Yao-San, 6.0g twice daily for 12 weeks.
Interventions
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Methylhydroxypropylcellulose
1-2 drips each time, every 4 hours, for 12 weeks.
Carbomer
1 drip each time, at bedtime, for 12 weeks.
TCM Formula
6.0g Chi-Ju-Di-Huang-Wan plus 6.0g Jia-Wei-Xiao-Yao-San, 6.0g twice daily for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A confirmed diagnosis of DED by ophthalmologists.
* Willing to sign informed consent form.
Exclusion Criteria
* Pregnant or lactating.
* Underwent transplant surgery and got graft-versus-host disease in the past.
* With eye infection, inflammation, trauma, or underwent eye surgery in the past three months.
* Underwent dry eye intense pulse light treatment in the past three months.
* Underwent other treatments including TCM drugs or acupuncture in the past month or during the trial.
* Persistent in taking diuretics, antidepressant, antihistamines and anticholinergics.
* Combined treatment with autologous serum, cyclosporine or steroid eye drops during the trial.
* Took fish oil or vitamin D during the trial.
20 Years
75 Years
ALL
No
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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Principal Investigators
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Hui-Ju Lin, PhD
Role: PRINCIPAL_INVESTIGATOR
China Medical University Hospital
Locations
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China Medical University Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Teng-I Huang, MD
Role: primary
Other Identifiers
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CMUH109-REC2-169
Identifier Type: -
Identifier Source: org_study_id