Bao Yuan Tang Extract and Galactooligosaccharides for Sleep Regulation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-45
SponsorHepatopancreatobiliary Surgery Institute of Gansu Province

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Combination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g)
  • Bao Yuan Tang full-component extract 2.0g plus a placebo consisting of maltodextrin 2.0g
  • Galactooligosaccharides 2.0g
  • maltodextrin placebo 4.0g

Treatment groups

400 Participants
are divided into 4 treatment groups