Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease
NCT ID: NCT06089317
Last Updated: 2024-08-21
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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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-07-28
2025-11-30
Brief Summary
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This is a randomized double-masked, active- and placebo-controlled trial. 200 subjects will be equally assigned to the herbal compound decoction(CD) group, dendrobium caulis (DC) group, houttuynia cordata (HC) group, placebo atomization(PA) group, and artificial tear (AT) group by stratified permuted block randomization.
Subjects of CD, DC, HC, and PA groups will receive TCM ultrasonic atomization treatment (6 times/week). All patients will receive hypromellose 0.3% w/v lubricant eye drops for a 1-week wash-out and a 4-month follow-up period. Outcomes included non-invasive tear break-up times, corneal and conjunctival fluorescein staining, and other dry eye-related parameter examined by LipiView II Ocular Surface Interferometer, OCULUS® Keratograph 5M, and slit lamp biomicroscope evaluated by masked clinical assessors at baseline, week 1, 2, 3, 4 and month 2, 3, 4. The other subjective questionnaires like the Ocular Surface Disease Index (OSDI) questionnaire are also selected.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Compound Decoction (CD) group
TCM ultrasonic atomization treatment with herbal Compound Decoction (CD)
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the CD group is TCM compound decoction.
The prescription of atomization solution in the CD group contains Honeysuckle flower (金銀花) 5g, Chrysanthemum flower (菊花) 5g, Pale betterflybush flower (密蒙花) 5g, Mild mint herb (薄荷) 5g, Barbary wolfberry fruit (枸杞子) 10g, and Ophiopogon japonicus (麥冬) 5g.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
Artificial Tears (AT)
The subjects will receive lubricant eye drop (Hypromellose 0.3% w/v Eye Drops) four times per day only.
Dendrobii Caulis (DC) group
TCM ultrasonic atomization treatment with Dendrobii Caulis (DC)
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the DC group is Dendrobii Caulis extracts.
The prescription of the DC group contains Dendrobium (石斛) 35g.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
Artificial Tears (AT)
The subjects will receive lubricant eye drop (Hypromellose 0.3% w/v Eye Drops) four times per day only.
Houttuynia Cordata (HC) group
TCM ultrasonic atomization treatment with Houttuynia Cordata (HC)
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the HC group is Heartleaf Houttuynia Herb extracts.
The prescription of the HC group contains Heartleaf Houttuynia Herb(魚腥草) 35g.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
Artificial Tears (AT)
The subjects will receive lubricant eye drop (Hypromellose 0.3% w/v Eye Drops) four times per day only.
Placebo Atomization (PA) group
Placebo TCM ultrasonic atomization treatment (PA)
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the PA group is low-concentration compound decoction (5%) same with the CD group.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
Artificial Tears (AT)
The subjects will receive lubricant eye drop (Hypromellose 0.3% w/v Eye Drops) four times per day only.
Artificial Tears (AT) group
Artificial Tears (AT)
The subjects will receive lubricant eye drop (Hypromellose 0.3% w/v Eye Drops) four times per day only.
Interventions
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TCM ultrasonic atomization treatment with herbal Compound Decoction (CD)
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the CD group is TCM compound decoction.
The prescription of atomization solution in the CD group contains Honeysuckle flower (金銀花) 5g, Chrysanthemum flower (菊花) 5g, Pale betterflybush flower (密蒙花) 5g, Mild mint herb (薄荷) 5g, Barbary wolfberry fruit (枸杞子) 10g, and Ophiopogon japonicus (麥冬) 5g.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
TCM ultrasonic atomization treatment with Dendrobii Caulis (DC)
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the DC group is Dendrobii Caulis extracts.
The prescription of the DC group contains Dendrobium (石斛) 35g.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
TCM ultrasonic atomization treatment with Houttuynia Cordata (HC)
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the HC group is Heartleaf Houttuynia Herb extracts.
The prescription of the HC group contains Heartleaf Houttuynia Herb(魚腥草) 35g.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
Placebo TCM ultrasonic atomization treatment (PA)
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the PA group is low-concentration compound decoction (5%) same with the CD group.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
Artificial Tears (AT)
The subjects will receive lubricant eye drop (Hypromellose 0.3% w/v Eye Drops) four times per day only.
Eligibility Criteria
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Inclusion Criteria
2. Ocular Surface Disease Index (OSDI)≥13 and \<33; and
3. The age range between years 18-80, no sex limitation; and
4. Symptoms of dry eye for at least 6 months; and
5. Can complete the questionnaires independently and understand Chinese or English.
Exclusion Criteria
2. Received any refractive surgery and corneal surgery before, including corneal transplant; or any eye surgery in the past 6 months;
3. Receiving DED-related medications, including topical steroid eyedrops, topical antibiotics, topical cyclosporin A, and topical diquafosol;
4. Received intense pulsed laser (IPL) or vectored thermal pulsation (VTP) therapy in the past 12 months;
5. Received topical antiglaucomatous treatment in the past 12 months
6. Plans to use contact lenses during treatment and follow-up periods or used contact lenses 2 weeks before the baseline measurement and recruitment;
7. Had or currently suffering from severe cardiopulmonary disease, liver and kidney dysfunction, and severe blood system diseases;
8. Suffering from glucose-6-phosphate dehydrogenase deficiency (G6PD);
9. Had or currently suffering from specific respiratory diseases, e.g. emphysema, bronchitis, asthma, chronic obstructive pulmonary disease, bronchial dilatation;
10. Has adverse reaction history to herbs used in this study before;
11. Whose TCM constitution is manifested as "yang-deficiency" or diagnosed by TCM practitioners that their TCM syndrome is not suitable for the atomization treatment;
12. Pregnancy, preparation for pregnancy, or lactation;
18 Years
80 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Kelvin Kam-lung Chong, MD
Associate Professor, Department of Ophthalmology and Visual Sciences, CUHK
Principal Investigators
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Kelvin KL Chong, MBChB
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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The Chinese University of Hong Kong Eye Centre (CUHKEC)
Kowloon, , Hong Kong
Hong Kong Eye Hospital
Kowloon, , Hong Kong
The CUHK Medical Centre (CUHKMC)
Shatin, , Hong Kong
Prince of Wales Hospital
Shatin, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CMDF-21B2005A_R1
Identifier Type: -
Identifier Source: org_study_id
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