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Clinical Study on the Efficacy of Huahong Granules Combined with Metronidazole in the Treatment of Bacterial Vaginosis

Clinical Study on the Efficacy of Huahong Granules Combined with Metronidazole in the Treatment of Bacterial Vaginosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000753
Enrollment
Unknown
Registered
2025-04-15
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

bacterial vaginosis

Interventions

Control group:Metronidazole
Intervention group:Huahong Granules Combined with Metronidazole

Sponsors

The Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1) It meets the Amsel diagnostic criteria for bacterial vaginosis; 2) In line with the syndrome differentiation standard of damp heat syndrome in traditional Chinese medicine; 3) Aged 20-55 years old, with a history of sexual life; 4) The patients voluntarily participated in the trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) complicated with other vaginitis, such as Trichomonas vaginalis, vulvovaginal candidiasis, or genital tract infection caused by suspected gonorrhea, herpes simplex virus infection, etc. (2) Patients with other serious gynecological diseases, such as gynecologic malignant tumors. (3) Patients with severe primary diseases such as heart, brain, liver, kidney, blood system and endocrine system, among which alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were > 2 times the upper limit of normal, and serum creatinine (SCR) was > the upper limit of normal. (4) The patient received any oral or topical drugs within 1 week before enrollment. (5) Pregnant and lactating women or those who plan pregnancy in the near future. (6) Those known to be allergic to the components of the test drug. (7) Those who are unable to cooperate due to neurological and mental disorders and those who suspect or have a history of alcohol and drug abuse. (8) Those who have participated in or are participating in other clinical trials within 1 month before screening. (9) The investigator considered it inappropriate to be selected.

Design outcomes

Primary

MeasureTime frame
Treatment efficiency;

Secondary

MeasureTime frame
Clinical symptom score;FSFI;

Countries

China

Contacts

Public ContactDan Nie

The Affiliated Hospital of Southwest Medical University

niedan@swmu.edu.cn+8613982771235

Outcome results

None listed

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