Persistent cervical infection with High-Risk Human Papillomavirus (HR-HPV)
Conditions
Interventions
Trial Group:Shenzhu Ermiao Granules, to be taken orally: one sachet each time, twice daily, for 12 consecutive weeks.
Control Group:Placebo, to be taken orally: one sachet per dose, twice daily, for 12 consecutive weeks.
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
21 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) The patient is aware of this study and has voluntarily signed the informed consent form; (2) Has a history of sexual activity, and is between 21 and 65 years of age; (3) Diagnosed with persistent cervical HR-HPV infection for 12 months or longer; (4) Meets the TCM diagnostic criteria for Dampness-Heat Stasis Syndrome; (5) Agrees to use barrier contraception during the trial participation period.
Exclusion criteria
Exclusion criteria: (1) Pregnancy, lactation, or planning to conceive within one year; (2) Cervical biopsy under colposcopy showing pathology of CIN2 or higher; (3) Patients with persistent cervical HR-HPV infection after surgical treatment or radiotherapy/chemotherapy for cervical lesions of CIN2 or higher; (4) Patients with severe heart, lung, liver, or kidney diseases, or those with immune system disorders or malignant tumors; (5) Use of corticosteroids or medications affecting the immune system within 8 weeks prior to screening, or receipt of systemic or local anti-HPV drug or non-drug therapies; (6) Presence of acute reproductive system infections or other infectious diseases; (7) Coinfection with trichomoniasis, fungal infection, aerobic vaginitis, or bacterial vaginosis; (8) Abnormal laboratory values: ALT or AST = 2 times the upper limit of normal (ULN), or creatinine exceeding ULN and deemed clinically significant by the investigator; (9) History of smoking, long-term oral contraceptive use, or alcohol/drug abuse; (10) Allergy to the investigational drug; (11) Presence of other uncontrolled diseases deemed by the investigator as unsuitable for participation; (12) Any other condition considered by the investigator to increase patient risk or interfere with trial results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Rate of High-Risk Human Papillomavirus Clearance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Traditional Chinese Medicine Syndrome Score;Single Symptom Disappearance Rate; | — |
Countries
China
Contacts
Public ContactGuojie
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed