T/CEMA 054-2026 Active Group standards

T/CEMA 054-2026 Expert Consensus on the Clinical Application of Kushen Gel

Publish Date: 2026-01-20 Implement Date: 2026-01-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CEMA 054-2026

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Video, pulse system equipment

ICS Name: Drugs

Publish Date: 2026-01-20

Implement Date: 2026-01-20

Scope

Modern pharmacological and pharmacodynamic studies have shown that its active ingredient, total alkaloids of Kudzu, has pharmacological effects such as anti-pathogenic microorganisms, anti-inflammation, analgesia and anti-itching, promoting the repair of vaginal mucosa, and restoring the proliferation of Lactobacillus vaginalis. At present, the drug has been included in several guidelines, such as the 2022 Clinical Application Guide for Traditional Chinese Medicine in the Treatment of Vaginitis and the 2021 Diagnosis and Treatment Guidelines for Bacterial Vaginosis. However, there is still no clinical application expert consensus for Kudzu gel in China and abroad. Therefore, the drafting group follows the standardized process of evidence-based guideline development at home and abroad, invites experts from multiple fields such as gynecology, pharmacy, and evidence-based medicine across the country to form a consensus drafting group. Through expert interviews, questionnaire surveys, and nominal group method, the group identifies clinical issues, retrieves and synthesizes literature evidence according to the PICOS principle, evaluates the evidence level using GRADE, and formulates consensus recommendations and suggestions through nominal group method. By drafting this document, it clarifies the advantages of Kudzu gel in the treatment of vulvovaginal candidiasis (VVC) and trichomonas vaginitis (TV), including the administration scheme and timing, dosage and treatment course characteristics, and safety issues, aiming to guide and standardize clinicians' rational use, improve clinical efficacy, reduce medication risks, and enhance the accuracy and safety of medication use.