Clinical Effect of Quyou Prescription in the Treatment of Persistent High-risk HPV Infectio

Phase 1

• Conditions: HPV infection

• Registration Number: ITMCTR2200006081
• Lead Sponsor: Fujian Provincial Maternity and Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

(1) meet one of the three conditions:?tested positive for HPV16/18 and pathological tissue result of LSIL or below,cervical colposcopy biopsy of LSIL or below,and LSIL lesions less than two years;?tested negative for HPV16 or 18,but positive for other types of high-risk HPV,cytological evidence of ACUS or above,cervical colposcopy biopsy of LSIL or below,and LSIL lesions less than two years;?tested negative for HPV16 or 18,but positive for other types of high-risk HPV,cytological evidence of NILM;
(2) homotype HPV infection more than half a year;
(3) conforming to the standard of TCM syndrome of dampness and heat;
(4) women aged 25-65 with a history of sexual life and regular menstrual cycles;
(5) patients with normal liver and kidney function and no history of severe drug allergy;
(6) gave informed consent volunteering to participate in the study.

Exclusion Criteria

(1) women who were not avoiding pregnancy,were pregnant, or were breastfeeding;
(2) those who had used other HPV drugs in the first 3 months of enrollment;
(3) patients participating in clinical trials of other drugs.;
(4) allergic constitution, such as allergic history of two or more drugs and food,or allergic to the ingredients of a given drug;
(5) patients with HSIL or above indicated by cervical biopsy under colposcopy.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cervical cytology;clearance rate of Hr-HPV;score of clinical symptom of TCM;