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Not yet recruiting NCT06818487

Ganyan-1 in Dry Eye

No phase Interventional Dry Eye TCM

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ganyan1, Sodium Hyaluronate, 1/2Ganyan1, Placebo.
Who it may be relevant to
Registry conditions: Dry Eye, TCM. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Ganyan-1 in Dry Eye: A Randomized Clinical Trial

Overview

Ganyan -1 for the patients with dry eye

Detailed description

Objective: Ganyan-1 for the patients with dry eye Methods: The investigators enrolled 219 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, week2, week4, week8, week12, and week16.

Interventions

  • Drug 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.
  • Drug Sodium Hyaluronate
    Participants received 0.1% sodium hyaluronate eye drop
  • Drug 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.
  • Drug 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.

Primary outcome measures

  • OSDI [Time frame: Baseline, week 2, 4, 8, 12 and 16]
Secondary outcome measures (6)
  • TBUT [Time frame: Baseline, week 2, 4, 8, 12 and 16]
  • Schirmer [Time frame: Baseline, week 2, 4, 8, 12 and 16]
  • SF-36 [Time frame: Baseline, week 2, 4, 8, 12 and 16]
  • SAS [Time frame: Baseline, week 2, 4, 8, 12 and 16]
  • SDS [Time frame: Baseline, week 2, 4, 8, 12 and 16]
  • OQAS II [Time frame: Baseline, week 2, 4, 8, 12 and 16]

Eligibility criteria

Inclusion criteria

1\. Age >=18 and Age <=70, complaint of DED symptoms for 6 months or longer at screening.

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

  • History systemic autoimmune diseases and ocular/periocular malignancy.
  • Clinically relevant slitlamp findings or abnormal lid anatomy.
  • Active ocular allergies and active infection.
  • Pregnant or lactating women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06818487 · DED_TCM_2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗