Multi-Center, Randomized Controlled Trial for Clinical Efficacy and Safety Evaluation of Traditional Chinese Medicine Instead of Antibiotics in The Treatment of Vulvovaginitis
- Conditions
- Vulvovaginitis in children
- Registration Number
- ITMCTR2000002913
- Lead Sponsor
- Beijing Children's Hospital, Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
(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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse rate;
- Secondary Outcome Measures
Name Time Method Cure rate;Safety observation index;Clinical recovery time;