Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Ganyan -1 for the patients with dry eye
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ganyan1 | Experimental |
| |
| 1/2Ganyan1 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganyan1 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| OSDI | The Ocular Surface Disease Index (OSDI) includes 12 questions grouped by poor symptoms and visual disturbance (light sensitivity, eyes feel gritty, painful or sore eyes, blurred vision or poor vision); visual function/tasks (problems when reading, driving at night, working on a computer or watching TV); and environmental questions (problems in windy conditions, places/ areas with low humidity or areas that are air conditioned). The scores range from 0 to 100. On the basis of the score, the patient's symptoms can be categorized as normal (0-12), mild dry eye (13-22), moderate dry eye (23-32), or severe dry eve (33-100). | Baseline, week 2, 4, 8, 12 and 16 |
| Measure | Description | Time Frame |
|---|---|---|
| TBUT | Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as seen in this progression of these slit lamps' photos over time. A TBUT under 10 seconds is considered abnormal. |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Wu, Doctor | Contact | 8613810988682 | wudong0120@outlook.com | |
| Haihong Lian, Doctor | Contact | 8618811612190 | lianhh123@163.com |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sodium Hyaluronate | Drug | Participants received 0.1% sodium hyaluronate eye drop |
|
| 1/2Ganyan1 | 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 | 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. |
|
| Baseline, week 2, 4, 8, 12 and 16 |
| Schirmer | The Schirmer test is objectively used to measure tear secretion without anesthetized. A healthy eye should wet more than 10 mm of the standard filter strip in 5 minutes. The travel rate along the test strip is proportional to the tear production rate. | Baseline, week 2, 4, 8, 12 and 16 |
| SF-36 | 36-Item Short Form Health Survey (SF36) measures quality of life on the basis of eight dimensions or concepts that are frequently used in health studies. These eight dimensions are estimated from eight subscales that examine physical functioning (SF36-PF), role functioning-physical (SF36-RP), bodily pain (SF36-BP), general health (SF36- GH), vitality (SF36-VT), social functioning (SF36-SF), role functioning-emotional (SF36-RE), mental health (SF36-MH) and reported health transition (SF36-HT). Item responses were ranaina from 0 (best) to 100 (worst), with hiaher scores are equivalent to areater severity of better quality of life. | Baseline, week 2, 4, 8, 12 and 16 |
| SAS | The SAS is a 20-item self-report instrument designed to assess anxiety symptoms in clinical and research settings. This scale ranges from 20 to 80, with lower scores indicating better self-reported mental health and fewer anxiety symptoms. | Baseline, week 2, 4, 8, 12 and 16 |
| SDS | Medical Outcomes from study 20-Item Self-Rating Depression Scale. This scale range is 0-100 with lower scores indicating better self-reported mental health. | Baseline, week 2, 4, 8, 12 and 16 |
| OQAS II | Medical Outcomes from the OQAS II Visual Quality Assessment The OQAS II measures visual quality using several optical parameters. Scores are generated based on metrics like the Modulation Transfer Function (MTF) and Objective Scatter Index (OSI). The scale ranges from 0-100, with lower scores indicating better optical quality and fewer distortions. Change is calculated as the score at follow-up time points (e.g., post-treatment or surgery) minus the baseline score. | Baseline, week 2, 4, 8, 12 and 16 |