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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NOT_YET_RECRUITING
NA
219 participants
INTERVENTIONAL
2025-07-01
2027-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ganyan1
Ganyan1
During the treatment period, participants will receive the following Chinese herbal granules, including Chrysanthemum, Dendrobium, Salvia miltiorrhiza, Gypsum Fibrosum, and Goji berries, administered twice daily at a dose of 10 g per time for a duration of 4 weeks.
Sodium Hyaluronate
Participants received 0.1% sodium hyaluronate eye drop
1/2Ganyan1
Sodium Hyaluronate
Participants received 0.1% sodium hyaluronate eye drop
1/2Ganyan1
During the treatment period, participants will receive the following Chinese herbal granules, including Chrysanthemum, Dendrobium, Salvia miltiorrhiza, Gypsum Fibrosum, and Goji berries, administered twice daily at a dose of 5 g per time for a duration of 4 weeks.
Placebo
Sodium Hyaluronate
Participants received 0.1% sodium hyaluronate eye drop
Placebo
Participants will receive the following placebo Chinese herbal granules, administered twice daily at a dose of 10 g per time for a duration of 4 weeks.
Interventions
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Ganyan1
During the treatment period, participants will receive the following Chinese herbal granules, including Chrysanthemum, Dendrobium, Salvia miltiorrhiza, Gypsum Fibrosum, and Goji berries, administered twice daily at a dose of 10 g per time for a duration of 4 weeks.
Sodium Hyaluronate
Participants received 0.1% sodium hyaluronate eye drop
1/2Ganyan1
During the treatment period, participants will receive the following Chinese herbal granules, including Chrysanthemum, Dendrobium, Salvia miltiorrhiza, Gypsum Fibrosum, and Goji berries, administered twice daily at a dose of 5 g per time for a duration of 4 weeks.
Placebo
Participants will receive the following placebo Chinese herbal granules, administered twice daily at a dose of 10 g per time for a duration of 4 weeks.
Eligibility Criteria
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Inclusion Criteria
3\. ocular surface disease index (OSDI) score of 25 or higher. 4. tear film breakup time (TFBUT) of 5 seconds or less. 5. Schirmer I test without anesthesia of 5 mm or more at 5 minutes. 6. CFS score of 4 or higher.
Exclusion Criteria
2. Clinically relevant slitlamp findings or abnormal lid anatomy.
3. Active ocular allergies and active infection.
4. Pregnant or lactating women.
18 Years
70 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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DED_TCM_2024
Identifier Type: -
Identifier Source: org_study_id
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