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NOT YET RECRUITING
NCT07774897
NA

Bao Yuan Tang Extract and Galactooligosaccharides for Sleep Regulation

Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

View on ClinicalTrials.gov

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.

Official title: Sleep-Promoting Effects of Bao Yuan Tang Whole-Component Extract Combined With Galactooligosaccharides: A Prospective, Multicenter, Triple-blind, Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

25 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-09-30

Completion Date

2027-09-30

Last Updated

2026-08-19

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

OTHER

maltodextrin placebo 4.0g

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

Locations (6)

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

The Second Hospital & Clinical Medical School, Lanzhou University

Lanzhou, Gansu, China

The Fourth Affiliated Hospital of Hebei University of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

The Seventh Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China