herpes zoster
Conditions
Interventions
high-dose group:TET 20mg*4,TID
low-dose group:TET 20mg*2+TET placebo 20mg*2,TID
control group:TET placebo 20mg*4,TID
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Able to understand and voluntarily sign the written informed consent form; 2. Male or female aged 18-75 years (inclusive) at screening; 3. Meeting the diagnostic criteria for herpes zoster as per the "Chinese Expert Consensus on Diagnosis and Treatment of Herpes Zoster (2022 Edition)" with presence of zoster-associated pain (ZAP), and within 7 days of rash onset prior to randomization; 4. Average pain VAS score >=40 mm in the past 24 hours assessed prior to randomization.
Exclusion criteria
Exclusion criteria: 1. Screening for patients who have taken tetrandrine tablets within the previous month; 2. Patients with ZAP in special areas; 3. Patients with peripheral neuropathy or pain unrelated to herpes zoster (including but not limited to those caused by cerebrovascular diseases, Guillain-Barré syndrome, cervical/lumbar spine diseases, bone/joint or tendon disorders, chronic kidney disease or uremia, thyroid diseases, intracranial tumors, trauma, etc.), and judged by the investigator as potentially affecting the efficacy evaluation of the investigational drug; 4. Patients with other active infections requiring targeted treatment at screening, and deemed unsuitable for inclusion by the investigator; 5. Patients with clinically significant diseases or medical history, judged by the investigator as potentially affecting the efficacy evaluation of the investigational drug; 6. Patients with severe cardiovascular or pulmonary diseases, such as unstable angina, myocardial infarction, severe arrhythmia, poorly controlled hypertension despite active treatment, recurrent asthma, etc.; 7. Patients with gastrointestinal or digestive system diseases (e.g., peptic ulcer, gastrointestinal bleeding, etc.), assessed by the investigator as affecting trial evaluation; 8. Patients with neuropsychiatric disorders, including but not limited to epilepsy, recurrent dizziness, headache, memory or cognitive impairment, or a history of significant suicidal intent/behavior, and judged by the investigator as potentially affecting the efficacy evaluation of the investigational drug or increasing study risks; 9. Patients with a history of retinal or other ocular diseases (e.g., scotoma, color blindness, visual defects, glaucoma, cataract, keratitis, vitreous opacity, elevated intraocular pressure, macular degeneration, etc.), and judged by the investigator as potentially affecting the efficacy evaluation of the investigational drug or increasing study risks; 10. Patients who used medications with therapeutic effects on herpes zoster within 1 week before screening (or 5 half-lives per drug label), including but not limited to opioids, acetaminophen, NSAIDs, ion channel blockers, tricyclic antidepressants, or traditional Chinese medicine/acupuncture with clear analgesic effects; 11. Patients who underwent minimally invasive interventions (e.g., nerve block or neuromodulation) or physical therapy with analgesic effects within 1 week before screening; 12. Patients who used topical analgesics (e.g., 5% lidocaine patch, capsaicin cream, etc.) within 1 day before screening; 13. Patients with a history of malignancy within 5 years before screening (excluding cured basal cell carcinoma, carcinoma in situ, and papillary thyroid carcinoma) or a history of antitumor therapy; 14. Patients with a history of drug abuse or alcoholism within 1 year before screening [weekly alcohol intake exceeding 14 units (1 unit = 360 mL beer, 45 mL 40% spirits, or 150 mL wine)]; 15. Patients with positive HBsAg and/or HBcAb and HBV-DNA exceeding the normal range at screening; HCV antibody-positive patients; or HIV-seropositive individuals; 16. Patients with abnormal laboratory results at screening, meeting any of the following criteria: a) Hematology: neutrophils 2.5×ULN; or TBIL >1.5×ULN; c) eGFR <60 mL/min/1.73 m² (calculated using the creatinine-based CKD-EPI formula); d) Creati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PHN incidence rate;Simplified McGill Pain Questionnaire;Hospital Anxiety and Depression Scale; | — |
Countries
China
Contacts
Public ContactCui Yong
China-Japan Friendship Hospital
Outcome results
None listed