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Multi-center clinical ?a study of Qijin Tuiyi Granules in the treatment of recurrent HSK

Multi-center clinical ?a study of Qijin Tuiyi Granules in the treatment of recurrent HSK

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000139
Enrollment
Unknown
Registered
2025-01-16
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Recurrent herpes simplex virus keratitis

Interventions

Experimental group:Qijin Tuyi Granule combined with ganciclovir eye gel. If there is epithelial defect during treatment, befusor eye drops or befusor gel can be added to the eyes, 2-6 times a day (dep
Control group:Qijin Tuyi Granule simulator combined with ganciclovir eye gel. If there are epithelial defects during treatment, befusor eye drops or befusor gel can be added to the eyes, 2-6 times a d

Sponsors

Eye Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.At least one eye meets the above western medicine diagnostic criteria and Chinese medicine syndrome diagnosis criteria; 2.Age 18-65 years old (male or female); 3.At least one recurrence and can provide evidence (such as cases diagnostic data prescriptions etc.); 4.Eyelid tissue does not interfere with corneal examination; 5. The subjects can understand and are willing to receive treatment and review according to the experimental protocol; 6. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. People who are allergic or allergic to known drug ingredients; 2. Patients with other ocular diseases (excluding drug-induced keratopathy other infectious and allergic keratopathy) or systemic diseases (such as corneal diseases other than HSK glaucoma retinal diseases uveitis optic neuritis diabetes with poor glycemic control (hemoglobin Aglycated =9%) systemic infections) that the investigator determined interfered with the evaluation of the efficacy of the investigational drug; 3. Moderate or severe liver dysfunction or serious heart lung renal dysfunction hematopoietic system diseases and psychiatric patients; 4.Patients with a history of malignant tumor within 5 years; 5. Unable to cooperate or unwilling to cooperate due to mental illness; 6. Persons with disabilities defined by law (blind deaf mute mentally handicapped etc.); 7. Suspected history of alcohol drug or drug abuse; 8. Pregnant or lactating women; 9. Women of childbearing age or subjects whose menopause is less than 12 months must undergo a blood/urine pregnancy test during the screening period and the result must be negative; 10. Patients who have participated in clinical trials of other drugs within the last 3 months; 11. The investigator considers it inappropriate to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
HSK recurrence rate;

Secondary

MeasureTime frame
Eye symptoms (photophobia, tears and pain, bloodshot eyes);TCM syndrome score;best corrected visual acuity;Corneal condition (slit-lamp examination, corneal fluorescence staining examination, photographic examination of anterior segment);Recurrence situation (recurrence number, recurrence interval);

Countries

China

Contacts

Public ContactZefeng Kang

Eye Hospital China Academy of Chinese Medical Sciences

zefeng2531@163.com13552597717

Outcome results

None listed

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