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Clinical trials of Bao fu Kang Shuan for treatment of cervical high-risk HPV infection

Compared to placebo to evaluat the efficacy andsafety of bao fu Kang Shuan for treatment of cervical high-risk HPV infection (the hot andhumid stasis syndrome of leukorrhagia) randomized, double-blind, parallel-group, multicenter clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005087
Enrollment
Unknown
Registered
2014-08-04
Start date
2010-09-27
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

The cervical high risk HPV infection

Interventions

Experimental group:Bao fu Kang Shuan

Sponsors

Guangan men Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. In line with the western medicine type cervical high risk HPV infection diagnosis, TCM syndrome differentiation for damp heat stasis syndrome; 2. Sexual life history, Age 30 to 55; 3. Cervical cytology test results is normal/inflammatory reaction or ASC - US/LSIL histopathological examination results for inflammation; 4. 6 months to 12 months prior to screening cervix high-risk type HPV HC2 inspecting at least 1 time for positive people; 5. Voluntary signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Genital tract inflammation (gonorrhea, chlamydia, Candida vaginitis, Trichomonas vaginitis, Bacterial vaginal disease Etc.); 2. In patients with CIN I-III; 3. Pregnancy, lactation, or intention of pregnancy women; 4. Patients of the womb; 5. The menopause women irregular menstruation, Including the period is more than 7 days or menstrual cycle less than 25 days or menstrual cycle more than 35 days; 6. A weakened immune system (Radiation andchemotherapy after, AIDS, SLE Etc.); 7. Laboratory results: ALT, AST more than The upper limit of normal by 1.5 times, Creatinine than normal ceiling; 8. People with diabetes; 9. Nearly three months by oral contraceptive birth control; 10. With cardiovascular, cerebrovascular, liver, kidney andhematopoietic system andother serious primary diseases andpsychiatric patients; 11. Allergic constitution or preserved woman Kang Shuan allergy drug ingredients; 12. Nearly three months treatment of HPV infection measures; 13. Nearly three months in other clinical trials; 14. Doubt or have alcohol anddrug abuse history, or according to the researchers judgement, can reduce the set of possibilities or complicate the group or other lesions, such as working environment change often, living environment is not stable, easy to cause lost to follow-up.

Design outcomes

Primary

MeasureTime frame
Negative conversion ratio of cervical high-risk HPV DNA;

Secondary

MeasureTime frame
Negative conversion ratio of cervical high-risk HPV DNA in the 8 months;Individual symptom scores;Improvement rate of cervical high-risk HPV DNA;TCM syndrome score;

Countries

China

Contacts

Public ContactRen Yujing
ryj89@163.com+86 13910783925

Outcome results

None listed

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