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Observation of the selective inhibition of BV flora in patients with bacterial vaginosis (BV) by the Qiarmgel

Observation of the selective inhibition of BV flora in patients with bacterial vaginosis (BV) by the Qiarmgel

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060231
Enrollment
Unknown
Registered
2022-05-22
Start date
2022-05-13
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

bacterial vaginosis (BV)

Interventions

Group Qiarmgel:Qiarmgel
Group metronidazole:metronidazole gel

Sponsors

First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age: 18 years old - women with a history of sexual life before menopause; 2. Asymptomatic BV patients; 3. Vaginal examination: pH > 4.5, Nugent score >= 7 points, white blood cell count: <10/hp; 4. No history of systemic antibiotic use in the past one week; 5. No history of sex life in the past three days, no bath, vaginal irrigation and drug administration; 6. Negative urine pregnancy test; 7. Subjects are willing to have no pregnancy plan from screening to treatment with the study drug and within 3 months after discontinuation and agree to take effective contraception (no sex or barrier contraception throughout the use of condoms).

Exclusion criteria

Exclusion criteria: 1.Pregnant and lactating women; 2.Vaginal secretion white blood cell count: >=10/hp; 3.Other vaginal or vulvar diseases; 4.History of diabetes, cardiovascular and cerebrovascular diseases, liver and kidney diseases, and hematopoietic system (ask about previous medical history); 5.Approaching the menstrual period: It is speculated that the date of the last menstrual period is speculated, and it is within 10 days from the next menstrual period. 6.There is a history of gel allergy.

Design outcomes

Primary

MeasureTime frame
Nugent score;pH;White blood cell count;

Secondary

MeasureTime frame
Vaginal discharge traits;Vaginal discharge odor;Vulvar redness and swelling;Vulvar pain;Itching;Painful urination;

Countries

China

Contacts

Public ContactAn Ruifang
anruifang@163.com+86 18991232090

Outcome results

None listed

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