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Multi-Center, Randomized Controlled Trial for Clinical Efficacy and Safety Evaluation of Traditional Chinese Medicine Instead of Antibiotics in The Treatment of Vulvovaginitis

Multi-Center, Randomized Controlled Trial for Clinical Efficacy and Safety Evaluation of Traditional Chinese Medicine Instead of Antibiotics in The Treatment of Vulvovaginitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000002913
Enrollment
Unknown
Registered
2020-01-12
Start date
2020-03-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Vulvovaginitis in children

Interventions

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
3 Years to 9 Years

Inclusion criteria

Inclusion criteria: (1) Meet the above diagnostic criteria for vulvovaginitis; (2) Aged 3 to 9 years old; Tanner stage I; (3) No antibiotics were used 2 weeks before enrollment; (4) Vaginal secretion culture + drug sensitivity test positive, (for Haemophilus influenzae or Streptococcus pyogenes); (5) It can obtain the consent of the guardian, fill out the informed consent form, and agree to participate in the clinical subject.

Exclusion criteria

Exclusion criteria: (1) Excluding fungal infections (2) At the same time suffering from infectious diseases that can affect the condition and treatment of vaginitis; (3) Those who have a history of allergic reactions to known antibiotics or who are allergic to the treatment of Chinese herbal ingredients; (4) Those who have used drugs to treat vulvovaginitis within 14 days; (5) Those who suffer from diseases such as heart, liver, kidney, respiration, digestive tract, nervous system, mental disorders and metabolic abnormalities; Or other diseases or physiological conditions that may interfere with the test results.

Design outcomes

Primary

MeasureTime frame
Relapse rate;

Secondary

MeasureTime frame
Cure rate;Safety observation index;Clinical recovery time;

Countries

China

Contacts

Public ContactJing Liu
lljjred@126.com+86 13370115026

Outcome results

None listed

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