Sleep DisturbanceNCT07774897
Bao Yuan Tang Extract and Galactooligosaccharides for Sleep Regulation
A study testing Combination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g) and Galactooligosaccharides 2.0g in people with Sleep Disturbance and Fatigue Syndrome, Chronic, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Fatigue Syndrome, Chronic, Endocrine Disorder
- What is being tested?
- Combination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g) and Galactooligosaccharides 2.0g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 6 sitesChina
- Study dates
- 30 Sep 2026to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650832
Yi Dai, Ph.D, +8615887800809, 179087201@qq.com
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Huaping Wei, MSN, +8613893146855, 1521583371@qq.com
The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, 730030
Xinman Dou, Ph.D, +8613909318916, douxm@lzu.edu.cn
The Fourth Affiliated Hospital of Hebei University of Traditional Chinese Medicine
Shijiazhuang, Hebei, 050031
Hu Chen, M.D., +8613933139501, 565302759@qq.com
The Seventh Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830028
Xing Wu, MSN, +8618099186318, 1484597330@qq.com
Xiangyang Central Hospital
Xiangyang, Hubei, 441000
Xiaohong Zhang, MSN, +8613972256041, 1207004166@qq.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Sleep Disturbance, Fatigue Syndrome, Chronic, Endocrine Disorder, Glucose Metabolism Disorder, Lipid Metabolism Disorders
- Being tested
- 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
- Keywords
- Bao Yuan Tang full-component extract, Galactooligosaccharides, Sleep quality, Prebiotic, Metabolic health
- Medical subject headings
- Parasomnias, Fatigue Syndrome, Chronic, Endocrine System Diseases, Glucose Metabolism Disorders, Lipid Metabolism Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g)Dietary supplement
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 2.0gDietary supplement
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 2.0gDietary supplement
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 4.0gOther
Participants will receive maltodextrin placebo (4.0g), administered twice daily, one sachet each time, for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Combination product group | Experimental | Bao Yuan Tang full-component extract (2.0g) and galactooligosaccharides (2.0g). Receives: Dietary Supplement: Combination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g) |
| Bao Yuan Tang group | Active comparator | Bao Yuan Tang full-component extract (2.0g) plus a placebo consisting of maltodextrin (2.0g). Receives: Dietary Supplement: Bao Yuan Tang full-component extract 2.0g plus a placebo consisting of maltodextrin 2.0g |
| Galactooligosaccharides group | Active comparator | galactooligosaccharides (2.0g) combined with a maltodextrin placebo (2.0g). Receives: Dietary Supplement: Galactooligosaccharides 2.0g |
| Placebo control group | Placebo comparator | maltodextrin placebo (4.0g). Receives: Other: maltodextrin placebo 4.0g |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Baseline (day 0), Day 10, and Day 21
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (day 0), Day 10, and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Contains Combination product group, Bao Yuan Tang group, Galactooligosaccharides group and Placebo control group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Wenbo Meng, M.D., Ph.D., Principal investigator, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774897
- Sponsor's protocol ID
- BYT-GOS-RCT-2026
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tian L, Lin Y, Yue P, Gao L, Wang L, Huang C, Zhao J, Jiang N, Xi J, Ma H, Liu Z, Zhong R, Fu W, Mi N, Bai M, Zhang B, Dai L, Li J, Chen H, Yuan J, Meng W. Oat β-Glucan and Galactooligosaccharides Influence Gallstone Formation by Modulating the Gut Microbiota, Particularly Desulfovibrionales. iMetaMed. 2026;2(1):e70029. doi: 10.1002/imm3.70029.
van Oortmerssen JAE, Mulder JWCM, Kavousi M, Roeters van Lennep JE. Lipid metabolism in women: A review. Atherosclerosis. 2025 Jun;405:119213. doi: 10.1016/j.atherosclerosis.2025.119213. Epub 2025 Apr 24.
PubMed 40300433Chen HC, Hsu NW, Chou P. Subgrouping Poor Sleep Quality in Community-Dwelling Older Adults with Latent Class Analysis - The Yilan Study, Taiwan. Sci Rep. 2020 Mar 25;10(1):5432. doi: 10.1038/s41598-020-62374-4.
PubMed 32214167Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771As-Sanie S, Mackenzie SC, Morrison L, Schrepf A, Zondervan KT, Horne AW, Missmer SA. Endometriosis: A Review. JAMA. 2025 Jul 1;334(1):64-78. doi: 10.1001/jama.2025.2975.
PubMed 40323608