Bao Yuan Tang Extract and Galactooligosaccharides for Sleep Regulation

Condition(s) studied

Investigational drug(s) / intervention(s)

Combination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g): Participants will receive a combination product consisting of Bao Yuan Tang full-component extract (2.0g) and galactooligosaccharides (2.0g). The intervention will be administered twice daily, one sachet each time, for 3 weeks.

Bao Yuan Tang full-component extract 2.0g plus a placebo consisting of maltodextrin 2.0g: Participants will receive Bao Yuan Tang full-component extract (2.0g) plus a placebo consisting of maltodextrin (2.0g). The intervention will be administered twice daily, one sachet each time, for 3 weeks.

Galactooligosaccharides 2.0g: Participants will receive galactooligosaccharides (2.0g) combined with a maltodextrin placebo (2.0g). The intervention will be administered twice daily, one sachet each time, for 3 weeks.

maltodextrin placebo 4.0g: Participants will receive maltodextrin placebo (4.0g), administered twice daily, one sachet each time, for 3 weeks.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Pittsburgh Sleep Quality Index (PSQI) — 1 month
  Sleep quality will be assessed the original standard PSQI. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The data will be collected daily from baseline (Day 0) to the end (Day 30).
• Serum cortisol — Baseline (day 0), Day 10, and Day 21
  Blood samples will be collected at the day of enrollment and 10 and 21 days thereafter to assess changes in serum cortisol levels, the normal reference range is 140-630 nmol/L.
• Serum total cholesterol and triglyceride — Baseline (day 0), Day 10, and Day 21
  Blood samples will be collected at the day of enrollment and 10 and 21 days thereafter to measure serum total cholesterol and triglyceride levels, the normal reference levels are \<5.2 mmol/L for total cholesterol and \<1.7 mmol/L for triglycerides.

Trial sites (6)

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