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Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease: A Multicentre, Randomized, Double-masked, Placebo-controlled Clinical Trial

Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease: A Multicentre, Randomized, Double-masked, Placebo-controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067257
Enrollment
Unknown
Registered
2023-01-01
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye disease (DED)

Interventions

Group A (Compound Decoction Group):Ultrasonic atomization of TCM compound decoction extracts, and Hypromellose topical eyedrops
Group B (Dendrobii Caulis Group):Ultrasonic atomization of Dendrobii Caulis extracts, and Hypromellose topical eyedrops
Group C (Houttuynia Cordata Group):Ultrasonic atomization of Houttuynia Cordata extracts, and Hypromellose topical eyedrops
Group D (Placebo Atomization Group):Ultrasonic atomization of low-concentration compound decoction extracts (5%), and Hypromellose topical eyedrops
Group E (Artificial Tears Group):Hypromellose topical eyedrops only

Sponsors

Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong; Chinese Medicine Development Fund - Chinese Medicine Applied Studies and Research Funding Scheme
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. At least one eye of the patients meets dry eye disease diagnostic criteria; 2. Ocular Surface Disease Index (OSDI) >=13 and <33; 3. Aged 18-80 years, no gender limit; 4. Symptoms of dry eye for at least 6 months; 5. Be able to understand Cantonese, Mandarin or English, read Chinese or English, and complete the questionnaire independently;

Exclusion criteria

Exclusion criteria: 1. Patients with other concomitant ocular surface diseases e.g. chronic conjunctivitis, ocular rosacea, cicatricial pemphigoid, graft-versus-host disease, limbal stem cell deficiency, severe ocular allergy; 2. Received any refractive surgery, corneal surgery including corneal transplant before, any eye surgery in the past 6 months; 3. Patients with severe cardiopulmonary disease, liver and kidney dysfunction, severe blood system diseases; 4. Patients with glucose-6-phosphate dehydrogenase deficiency (G6PD); 5. Patients who had or are currently suffering from specific respiratory diseases, including emphysema, bronchitis, asthma, chronic obstructive pulmonary disease, bronchial dilatation, etc.; 6. Patients who had adverse reactions to herbs used in this study before, such as allergies; 7. Pregnancy, preparation for pregnancy, or lactation; 8. DED patients being treated with other medications, including the topical steroid eyedrops, topical antibiotics, topical cyclosporin A, topical diquafosol; patients who receive topical antiglaucomatous treatment in the past 12 months; 9. DED patients with a history of intense pulsed laser (IPL) or vector heat pulse (VTP) therapy in the past 12 months; 10. Patients whose TCM constitution is manifested as ''yang-deficiency'' (with pale complexion, cold hands and feet, lack of energy, loose stools, etc). Or those who have been diagnosed by TCM practitioners that their TCM syndrome is not suitable for the atomization treatment; 11. Continue to use contact lenses during treatment and follow-up periods or who has used contact lenses 2 weeks before the baseline measurement and recruitment.

Design outcomes

Primary

MeasureTime frame
Ocular Surface Disease Index (OSDI);Non-Invasive Keratograph Break Up Times (NIKBUT);Cornea and Conjunctival Fluorescein Staining (CFS);

Countries

China

Contacts

Public ContactDr CHONG Kam Lung Kelvin

Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong

chongkamlung@cuhk.edu.hk+852 39435823

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026