Ganyan-1 in Dry Eye

NCT ID: NCT06818487

Last Updated: 2025-06-25

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-02-01

Brief Summary

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Ganyan -1 for the patients with dry eye

Detailed Description

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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.

Conditions

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Dry Eye TCM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ganyan1

Group Type EXPERIMENTAL

Ganyan1

Intervention Type DRUG

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

Intervention Type DRUG

Participants received 0.1% sodium hyaluronate eye drop

1/2Ganyan1

Group Type EXPERIMENTAL

Sodium Hyaluronate

Intervention Type DRUG

Participants received 0.1% sodium hyaluronate eye drop

1/2Ganyan1

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Sodium Hyaluronate

Intervention Type DRUG

Participants received 0.1% sodium hyaluronate eye drop

Placebo

Intervention Type DRUG

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.

Intervention Type DRUG

Sodium Hyaluronate

Participants received 0.1% sodium hyaluronate eye drop

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

1. History systemic autoimmune diseases and ocular/periocular malignancy.
2. Clinically relevant slitlamp findings or abnormal lid anatomy.
3. Active ocular allergies and active infection.
4. Pregnant or lactating women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Dong Wu, Doctor

Role: CONTACT

8613810988682

Haihong Lian, Doctor

Role: CONTACT

8618811612190

Other Identifiers

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DED_TCM_2024

Identifier Type: -

Identifier Source: org_study_id

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