An interventional study of Combination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g) and Bao Yuan Tang full-component extract 2.0g plus a placebo consisting of maltodextrin 2.0g in Sleep Disturbance, Fatigue Syndrome, Chronic and Endocrine Disorder, sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province. Not yet recruiting at 6 sites in China. Open to female participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province · Not applicable, Interventional, and Treatment
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.
263 studies on the registry are indexed under Fatigue Syndrome, Chronic; 61 are open to participants now.
This study's planned enrollment of 400 is above the median of 60 across 177 interventional studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →Hepatopancreatobiliary Surgery Institute of Gansu Province is the lead sponsor of 44 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bao Yuan Tang full-component extract (2.0g) and galactooligosaccharides (2.0g).
Dietary Supplement: 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).
Dietary Supplement: Bao Yuan Tang full-component extract 2.0g plus a placebo consisting of maltodextrin 2.0g
galactooligosaccharides (2.0g) combined with a maltodextrin placebo (2.0g).
Dietary Supplement: Galactooligosaccharides 2.0g
maltodextrin placebo (4.0g).
Other: maltodextrin placebo 4.0g
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.
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.
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.
Participants will receive maltodextrin placebo (4.0g), administered twice daily, one sachet each time, for 3 weeks.
Pittsburgh Sleep Quality Index (PSQI)
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).
Time frame: 1 month
Serum cortisol
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.
Time frame: Baseline (day 0), Day 10, and Day 21
Serum total cholesterol and triglyceride
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.
Time frame: Baseline (day 0), Day 10, and Day 21
Changes in sleep efficiency
Sleep efficiency is calculated as total sleep time divided by time spent in bed × 100%, with ≥85% generally considered normal. The change from baseline (Day 0) to the end of the intervention (Day 30) will be evaluated.
Time frame: 1 month
Sleep onset latency
Sleep onset latency is defined as the time from attempting to fall asleep to sleep onset, with \>30 minutes generally indicating difficulty initiating sleep. The change from baseline (Day 0) to the end of the intervention (Day 30) will be evaluated.
Time frame: 1 month
Multidimensional Fatigue Inventory (MFI-20)
Fatigue will be assessed using the original standard MFI-20. It includes five domains, each scored from 4 to 20, with higher scores indicating greater fatigue. The data will be collected daily from baseline (Day 0) to the end (Day 30).
Time frame: 1 month
Fasting blood glucose
Blood samples will be collected at the day of enrollment and 10 and 21 days thereafter to measure fasting blood glucose levels, The normal reference range is 3.9-6.1 mmol/L.
Time frame: Baseline (day 0), Day 10, and Day 21
Cluster of differentiation 4 positive/Cluster of differentiation 8 positive T-cell ratio
Peripheral blood samples will be collected on the day of enrollment and on Days 10 and 21 thereafter to measure the CD4+/CD8+ T-cell ratio by flow cytometry. The normal reference range is approximately 1.5 - 2.5.
Time frame: Baseline (Day 0), Day 10, and Day 21
Serum estradiol (E2)
Blood samples will be collected on the day of enrollment and on Days 10 and 21 thereafter to measure serum estradiol (E2) levels. The reference ranges are 20 - 250 pg/mL in the follicular phase, 190 - 649 pg/mL during ovulation, and 21 - 350 pg/mL in the luteal phase.
Time frame: Baseline (Day 0), Day 10, and Day 21
Gut microbiota analysis
Stool samples will be collected on the day of enrollment and on Days 10 and 21 thereafter for gut microbiota analysis, Changes in α-diversity, β-diversity, and differential microbiota will be assessed.
Time frame: Baseline (day 0), Day 10, and Day 21
Plan to share: No
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Hepatopancreatobiliary Surgery Institute of Gansu Province