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Effects of Bi Ling Zhidai Tablet on vaginal microecology and clinical prognosis in patients with VVC

Effects of Bi Ling Zhidai Tablet on vaginal microecology and clinical prognosis in patients with VVC

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052997
Enrollment
Unknown
Registered
2021-11-07
Start date
2021-11-10
Completion date
Unknown
Last updated
2022-08-30

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

Conditions

Vulvovaginal candidiasis

Interventions

Standard Control Group:Clotrimazole suppository for external use
Treatment Group:Bi Lingzhi dai tablet oral and clotrimazole suppository for external use
Healthy control group:none

Sponsors

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for the healthy control group: no vaginitis-related clinical symptoms; vaginal cleanliness grades in I-II grades; no Candida spores or hyphae were found in laboratory examination of vaginal secretions; normal menstruation; no Find cervical lesions, uterine tumors, ovarian tumors and other gynecological diseases; 2. Inclusion criteria of the tested patients: (1) Subjects must meet the diagnostic criteria of traditional Chinese and Western medicine: 1) Western medicine diagnostic criteria: refer to the diagnosis and treatment criteria for vulvovaginal candidiasis (VVC) issued by the Infection Collaborative Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association in 2012; Clinical manifestations: Symptoms: genital itching, burning pain, accompanied by symptoms such as dysuria and dyspareunia; increased leucorrhea. Signs: vulvar flushing, edema, visible scratches or chapped, white membrane attached to the inner side of the labia minora and vaginal mucosa, and more white bean dregs-like secretions can be seen in the vagina, which may be curd-like; Laboratory examination: microscopic examination of secretions revealed fungal hyphae and spores; 2) TCM diagnostic criteria: refer to the diagnostic criteria of vulvovaginal candidiasis in the 3rd edition of "Integrated Traditional Chinese and Western Medicine Obstetrics and Gynecology" in 2018 and the National Standard of the People's Republic of China GB/T 16751.2-1997 "Traditional Chinese Medicine Clinical Diagnosis and Treatment Terminology (Syndromes) Waiting section)"; Syndrome characteristics: increased leucorrhea, white color like curd or bean dregs, genital itching, lack of appetite, abdominal distension, loose stools, heavy or slightly swollen body, pale, fat tongue with white or greasy fur, slow pulse; (2) Females aged 18-65; (3) Have no recent birth plan and agree not to have sex during the trial; (4) Those who agree to participate in the experiment of this project and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Diabetic patients; pregnant women, lactating women, allergic constitution or allergic to the known ingredients of the medicines of this project; 2. Those who have serious primary diseases of the heart, liver, kidney hematopoietic system and other important organs and systems; those who are unable to cooperate, or those who are unwilling to cooperate; those who have used similar drugs within a week ( Including internal and external use); those who have participated in other clinical trials within the past three months.

Design outcomes

Primary

MeasureTime frame
Mycological examination;Evaluation of vaginal cleanliness;

Secondary

MeasureTime frame
Comfort rating scale;Grading Standard of severity of TCM Syndrome;

Countries

China

Contacts

Public ContactChen Zhixia

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

chenzx116@163.com+86 13570206868

Outcome results

None listed

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