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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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
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
Are there results?
Not yet: the study is under way

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.

Wenbo Meng, M.D., Ph.D. contact

+8613919177177

mengwb@lzu.edu.cn

Liang Tian, M.D. contact

+8615293146623

tianl2024@lzu.edu.cn

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

Other trials in China

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.

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 groups in NCT07774897
Study groupRoleWhat they receive
Combination product groupExperimentalBao 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 groupActive comparatorBao 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 groupActive comparatorgalactooligosaccharides (2.0g) combined with a maltodextrin placebo (2.0g).
Receives: Dietary Supplement: Galactooligosaccharides 2.0g
Placebo control groupPlacebo comparatormaltodextrin 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.

  1. 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

  2. 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

  3. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted19 Aug 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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)
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 40300433

  • Chen 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 32214167

  • Buysse 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 2748771

  • As-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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenbo Meng, M.D., Ph.D. (+8613919177177, mengwb@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh Sleep Quality Index (PSQI) (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07774897, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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