A Clinical Study of Chinese Herbal Formula TJAOA103 in Treating Genitourinary Syndrome of Menopause

Genitourinary syndrome of menopause (GSM) refers to a collection of symptoms and signs such as atrophy of the genital and urinary tracts and sexual dysfunction in women during the menopausal transition and postmenopausal period due to the decline in estrogen and other sex hormone levels. The primary pathogenesis is rooted in ovarian aging. GSM not only causes persistent discomfort and increases the risk of infections but also significantly impairs sexual function and self-esteem in middle-aged and older women. Furthermore, the failure of ovarian hormone function will markedly elevate the risk of aging-related diseases such as cardiovascular events, Alzheimer's disease, and osteoporosis in these patients, shortening their healthspan and increasing all-cause mortality. Therefore, timely intervention for GSM is crucial.

At present, vaginal moisturizers, lubricants, and vaginal estrogen preparations are commonly used in clinical practice to alleviate the symptoms of GSM. Vaginal moisturizers and lubricants help protect the vaginal epithelium and maintain an acidic vaginal environment, but may cause vaginal burning, infections, or allergic reactions. Vaginal estrogen preparations exert their effects on estrogen receptors within the genitourinary system, yet the long-term safety remains uncertain. Ospemifene, a selective estrogen receptor modulator, is another treatment option; however, its weak estrogenic effects may pose risks of thrombosis or endometrial thickening with prolonged use. In addition, laser therapy has also been employed for GSM, but carries potential safety risks including vaginal burns, scarring, and chronic pain.

Traditional Chinese medicine (TCM) possesses distinctive advantages in anti-aging strategies, addressing both symptoms and root causes with commendable safety profiles, thereby rendering it particularly appropriate for middle-aged and elderly populations. Numerous studies have demonstrated the effectiveness of TCM in the management of GSM-related conditions, such as postmenopausal vaginal dryness, atrophic vaginitis, and menopausal urethral syndrome. However, due to the limited understanding of the disease, existing TCM prescriptions have lacked specificity for GSM and often rely on empirical combinations without solid scientific foundation. To solve this problem, we have invented a novel TCM formula, Tongji Anti-Ovarian Aging 103 (TJAOA103). First, we performed an extensive literature retrieval to collect TCM prescriptions effective in alleviating GSM-associated symptoms. Using the TCM Inheritance Support System and the TCM Systems Pharmacology Database and Analysis Platform, we screened out a variety of candidate Chinese herbs and combinations with potential therapeutic effects on GSM, based on its pathogenesis. Then, a panel of senior experts in gynecology, TCM, and pharmacy thoroughly discussed the pharmacological actions, synergistic effects, contraindications, and dosages of these herbs, and developed the initial formula of TJAOA103. Subsequently, we utilized multiple models to verify the safety and effectiveness of TJAOA103, and further optimized the formulation.

This is a prospective, single-arm clinical study designed to evaluate the safety and efficacy of the TCM formula TJAOA103 in women diagnosed with GSM. Using a pre-post analysis, we will assess the improvements in clinical symptoms, signs, sexual function, genitourinary health, and quality of life in participants with GSM following TJAOA103 administration to provide a safe and reliable novel therapeutic strategy for this population.

• total score of GSM symptoms [Срок оценки: From enrollment to the end of treatment at 4 or 12 weeks]
• score for a specific GSM symptom [Срок оценки: From enrollment to the end of treatment at 4 or 12 weeks]
• Vaginal Health Index Score (VHIS) [Срок оценки: From enrollment to the end of treatment at 4 or 12 weeks]
• vaginal pH [Срок оценки: From enrollment to the end of treatment at 4 or 12 weeks]
• Female Sexual Function Index-6 (FSFI-6) [Срок оценки: From enrollment to the end of treatment at 4 or 12 weeks]
• Overactive Bladder Syndrome Score (OABSS) [Срок оценки: From enrollment to the end of treatment at 4 or 12 weeks]
• score of International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) [Срок оценки: From enrollment to the end of treatment at 4 or 12 weeks]
• score of Menopause-Specific Quality of Life Questionnaire (MENQOL) [Срок оценки: From enrollment to the end of treatment at 4 or 12 weeks]