High-risk human papillomavirus infection of cervix
Conditions
Interventions
test team:Subjects take Jiawei Ermiao Granules twice a day, 2 bags each time. After 7 days of clean menstruation, they begin to take Jiawei Ermiao Granules orally. After 14 days of continuous administ
control group:Subjects took Jiawei Ermiao granule placebo twice a day, 2 bags each time. After 7 days of clean menstruation, they began to take Jiawei Ermiao granule placebo orally, and stopped taking
Sponsors
Traditional Chinese Medicine Hospital of Jiangsu Province
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Unmenopausal women who are over 18 years old have a history of sexual life and have regular menstrual cycles; 2. Two adjacent HPV DNA typing tests are positive for high-risk HPV (time interval =6 months) and it is required that there is at least one same high-risk type in the two tests; Cytological or histopathological diagnosis was LSIL or CIN I or below; 3. It accords with the diagnosis of leukorrhagia in TCM and the syndrome differentiation is damp-heat downward flow syndrome; 4. There is no pregnancy plan during the trial and within 6 months after the trial; 5. Volunteer to participate in the experimental study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of cervical surgery within 6 months before screening; 2. There are other sexually transmitted diseases (such as syphilis AIDS etc.) other than HPV infection during the screening period; 3. There are immune system diseases during the screening period or those who are taking immunosuppressants; 4. Complicated with serious primary diseases such as heart brain liver kidney and hematopoietic system affecting drug users; 5. Liver and kidney function damage ALT AST= 1.5 times the upper limit of normal value and Cr exceeds the upper limit of normal value; 6. Used drugs (including Chinese medicines chemical medicines biological products etc.) for treating HPV infection or products with mechanical name and small name within one month before screening; 7. Random blood glucose = 11.1 mmol/L during the screening period; 8. Those who have been vaccinated with HPV vaccine or plan to be vaccinated with HPV vaccine during the trial; 9. Those who are known to be allergic to the drug ingredients in this test; 10. Suffering from mental illness and unable to cooperate; 11. Those who have participated in other clinical trials within 3 months before the screening period; 12.The researchers think it is not suitable to join the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negative conversion rate of HPV; | — |
Secondary
| Measure | Time frame |
|---|---|
| The total score of TCM syndromes;The reversal rate of LSIL/CIN I;The specific negative conversion rate of single typing; | — |
Countries
China
Contacts
Public ContactQingling Ren
Traditional Chinese Medicine Hospital of Jiangsu Province
Outcome results
None listed