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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2100004600
Enrollment
Unknown
Registered
2021-01-01
Start date
2021-09-01
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

RVVC

Interventions

Sponsors

The Fifth Affiliated Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Vaginal microecology;

Countries

China

Contacts

Public ContactRuan Lijun

The Fifth Affiliated Hospital of Southern Medical University

459628652@qq.com+86 13427540323

Outcome results

None listed

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