Bao Yuan Tang Extract and Galactooligosaccharides for Sleep Regulation

Sleep-Promoting Effects of Bao Yuan Tang Whole-Component Extract Combined With Galactooligosaccharides: A Prospective, Multicenter, Triple-blind, Randomized Controlled Trial

Certain classical formulas in traditional Chinese medicine and dietary prebiotics have demonstrated beneficial effects on various aspects of suboptimal health status in previous studies. This research aims to evaluate the effects of Bao Yuan Tang full-component extract combined with galactooligosaccharides on improving health-related outcomes in female registered nurse with suboptimal health status, including sleep disturbances, fatigue, endocrine dysregulation, and glucose and lipid metabolic abnormalities.

The prevalence of suboptimal health status, including sleep disturbances and endocrine dysregulation, has been increasing in recent years, highlighting the significant public health and social implications of developing effective health-promoting interventions. Bao Yuan Tang, a classic traditional Chinese medicine formula with a long history of clinical application, has shown notable benefits in regulating various aspects of suboptimal health status, such as sleep disturbances. All herbs in the composition of Bao Yuan Tang, including Codonopsis Radix (Dangshen), Astragali Radix (Huangqi), Glycyrrhizae Radix et Rhizoma (Gancao), Cinnamomi Cortex (Rougui), Ziziphi Spinosae Semen (Suanzaoren), and charred jujube (Jiaozao), are listed in the catalogue of substances traditionally recognized as both food and Chinese medicinal materials issued by the National Health Commission of the People's Republic of China and the State Administration for Market Regulation. However, high-quality clinical studies evaluating its actual efficacy remain limited to date.

Galactooligosaccharides (GOS), forming a widely used class of dietary prebiotics, have also been shown potential benefits in improving conditions such as metabolic abnormalities, constipation, and obesity through modulation of the gut microbiota. Based on these findings, we developed a combination product containing Bao Yuan Tang full-component extract and GOS to investigate whether this combination could exert synergistic effects on improving suboptimal health status. This study is planned to evaluate the effects of a combination product, and Bao Yuan Tang extract or GOS alone, in young female registered nurse aged 25-45 years with night-shift exposure on suboptimal health status-related outcomes, including sleep disturbances, fatigue, endocrine dysregulation, and glucose and lipid metabolic abnormalities. Given the unique occupational characteristics of nursing staff, including irregular working hours and substantial work-related stress, this population considered suitable for inclusion in the present study.

Inclusion Criteria:

• Female registered nurses aged 25-45 years.
• Participants must meet at least one of the following criteria, self-reported presence of at least one target symptom of the trial, including insomnia, daytime fatigue, or difficulty initiating sleep or Pittsburgh Sleep Quality Index (PSQI) score >7.
• Engagement in shift work for at least one month before enrollment, with either ≥ 4 night shifts or ≥32 hours of night-shift work during the preceding month.

Exclusion Criteria:

• Diagnosed with type 1 or type 2 diabetes mellitus and currently receiving pharmacological treatment.
• Diagnosed with clinically thyroid dysfunction, including hyperthyroidism or hypothyroidism, and currently receiving pharmacological treatment.
• Diagnosed with Cushing's syndrome, pituitary dysfunction, or other clearly defined endocrine disorders.
• Diagnosed with polycystic ovary syndrome (PCOS) and currently receiving pharmacological treatment.
• Use of medications that may affect study outcomes, including oral contraceptives, glucose-lowering agents, hormonal medications, hypnotics, lipid-regulating agents, or thyroid hormone preparations, within the past 3 months.
• Pregnancy, lactation, or planned pregnancy during the study period.
• Confirmed severe organic diseases, such as hepatic or renal insufficiency, cardiovascular disease, or malignancy.
• Known allergy to any component of the investigational product.
• Use of probiotics, prebiotics, or related traditional Chinese medicine preparations within the past 1 month.
• Participation in another clinical trial within the past 3 months.
• Planned engagement in vigorous exercise or a weight-management program during the study period.
• A previous diagnosis of psychiatric disorders, such as anxiety or depression.
• Any condition judged by the investigator to involve communication difficulties, poor compliance, or potential interference with adherence to the study protocol.