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Study on the difference of distribution of bacterial flora of vaginitis with spleen deficiency type in the third trimester of pregnancy from the vaginal microecology and the intervention effect of Wandai Decoction

Study on the difference of distribution of bacterial flora of vaginitis with spleen deficiency type in the third trimester of pregnancy from the vaginal microecology and the intervention effect of Wandai Decoction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070870
Enrollment
Unknown
Registered
2023-04-25
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

bacterial vaginosis

Interventions

Treatment of bacterial vaginosis of spleen deficiency type during pregnancy with Wandai Tang:Wandai Decoction
Normal control group of vaginal microbiota during pregnancy:NA

Sponsors

Department of Obstetrics and Gynecology, Affiliated Hospital of Gansu University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 39 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria (1) Those who meet the diagnostic standards of TCM and Western medicine, and the syndrome differentiation of TCM is spleen deficiency; (2) Age between 20 and 40 years old, 32>= 37 weeks of gestation; (3) Patients who received treatment in the outpatient department of Associate Professor Zhao Fanqin in the Affiliated Hospital of Gansu University of Chinese Medicine and continued to take the soup; (4) Voluntarily agree to join this study, sign relevant informed consent, and be willing to bear the possible consequences and risks; (5) Those who can insist on completing all courses of treatment required by this study and receive treatment, observation and examination as required; (6) Willing to cooperate closely with interviewees; (7) Patients who did not use other hormone drugs and traditional Chinese medicine for treatment.

Exclusion criteria

Exclusion criteria: Exclusion criteria (1) Those who do not meet the diagnostic standards of Western medicine and TCM syndrome differentiation. (2) Patients with other genital tract inflammation, such as vulvovaginal candidiasis and trichomoniasis vaginitis; (3) Patients with autoimmune diseases and other diseases causing low immunity; (4) Repeated vaginal bleeding of placenta previa: (5) gestational diabetes mellitus (6) Having sex within one week; (7) Patients who have recently taken similar drugs for treatment, oral or vaginal external use of related or antagonistic drugs, and it is difficult to judge the efficacy of drugs or do not use drugs according to regulations, unable to judge the efficacy or incomplete data affect the efficacy or safety. (8) Allergic to multiple drugs; (9) Patients who fail to take medication on time and cannot judge the efficacy; (10) Allergic constitution or allergic to the study drug; (11) Unable to cooperate, such as complicated with neurological or mental diseases, or unwilling to cooperate;

Design outcomes

Primary

MeasureTime frame
Microbial 16rDNA sequencing technology;vaginal microecology;blood routine examination;interleukin-6;tumor necrosis factor;beta streptococcus;

Countries

China

Contacts

Public ContactFenqin Zhao

Affiliated Hospital of Gansu University of Chinese Medicine

zfqlzh@163.com+86 13893184887

Outcome results

None listed

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