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Study on vaginal microecology of recurrent vulvovaginal candida disease combined with spleen deficiency and dampness syndrome and damp-heat syndrome

Phase 1
Conditions
RVVC
Registration Number
ITMCTR2100004600
Lead Sponsor
The Fifth Affiliated Hospital of Southern Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

1 RVVC group
(1) Those who meet the above-mentioned diagnostic criteria and are classified into spleen deficiency and dampness syndrome or damp-heat syndrome.
(2) Female, aged 20-45, married or having sex, with regular and normal menstrual cycles.
(3) At least 2 or more symptoms or signs of VVC, 4 or more episodes of VVC in the past year.
(4) No antibiotics and probiotics were used in the two weeks before selection.
(5) Those who voluntarily participate and sign the informed consent.
2 VVC group
(1) Those who meet the above-mentioned diagnostic criteria and are classified into spleen deficiency and dampness syndrome or damp-heat syndrome.
(2) Female, aged 20-45, married or having sex, with regular and normal menstrual cycles.
(3) Examination of vaginal secretions: positive for Candida, at least 2 or more symptoms or signs of VVC, no history of VVC attacks in the past year.
(4) No antibiotics and probiotics were used in the two weeks before selection.
(5) Those who voluntarily participate and sign the informed consent.
3 Normal control group
(1) Female, aged 20-45, married or having sex, with regular and normal menstrual cycles.
(2) Select healthy non-pregnant women.
(3) Examination of vaginal discharge: negative.
(4) No antibiotics and probiotics were used in the two weeks before selection.
(5) Those who voluntarily participate and sign the informed consent.

Exclusion Criteria

1. Women during pregnancy and lactation;
2. Patients suffering from diabetes and oral contraceptives;
3. Patients with severe disease of the heart, liver, kidney and other major organs, hematopoietic diseases, and tumors who cannot guarantee the smooth progress of this study;
4. Those who are unable to cooperate, such as those who have a history of neurological and mental illness or are unwilling to cooperate;
5. Those who have received systemic antifungal treatment within 3 months or have received topical antifungal treatment within 1 month;
6. Those who have immunological diseases or are taking immunosuppressants or regulators, or those who have been vaccinated one year before joining the group;
7. Mixed vaginal infection: such as mixed trichomoniasis, bacterial vaginitis, mycoplasma, chlamydia infection;
8. Subjects who are participating in other clinical trials.

Study & Design

Study Type
Observational study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Vaginal microecology;
Secondary Outcome Measures
NameTimeMethod
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