Traditional Chinese Medicine Herbal Sachet for Insomnia in Older Adults

NCT07788547 | Completed

• 1 other identifier: FCSD/MSN-0075/2023
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial was to determine whether nightly exposure to a Traditional Chinese Medicine herbal sachet could reduce insomnia symptoms and improve sleep quality in adults aged 60 years or older. Participants residing in five community-based integrated medical and elderly-care facilities in Qingdao, China, were assigned by chance to receive either the herbal sachet or a placebo sachet. Participants placed the assigned sachet within 30 centimeters of the head from 7:00 p.m. to 8:00 a.m. each night for eight weeks. Insomnia symptoms and sleep quality were assessed using the Athens Insomnia Scale and Pittsburgh Sleep Quality Index. Adverse reactions were monitored throughout the intervention

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Insomnia; Older Adults; Traditional Chinese Medicine; Chinese Herbal Sachet; Aromatherapy; Sleep Quality; Long-Term Care Facilities

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI) Total Score

  The PSQI assesses sleep quality during the previous month. It contains 19 self-rated items and 5 other-rated items. Eighteen self-rated items produce 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, producing a total score from 0 to 21. Higher scores indicate poorer sleep quality.

  Baseline (Day 1), Day 28, and Day 56

Secondary Outcomes (1)

• Athens Insomnia Scale (AIS) Total Score

  Baseline before intervention, Day 28, and Day 56

Study Arms (2)

Traditional Chinese Medicine Herbal Sachet

EXPERIMENTAL

Participants received usual sleep-related care plus a 100-g compound traditional Chinese medicine herbal sachet. The sachet was placed beside the pillow within 30 cm of the participant's head from 7:00 p.m. to 8:00 a.m. every night for 8 weeks. Sachets were collected and sealed each morning and replaced every 2 weeks.

Other: Traditional Chinese Medicine Herbal Sachet

Placebo Herbal Sachet

PLACEBO COMPARATOR

Participants received the same usual sleep-related care and schedule using a 100-g placebo herbal sachet. The placebo sachet had the same packaging as the experimental sachet but contained a different herbal mixture considered not to affect sleep. Sachets were placed within 30 cm of the participant's head from 7:00 p.m. to 8:00 a.m. every night for 8 weeks and replaced every 2 weeks.

Other: Placebo Herbal Sachet

Interventions

Traditional Chinese Medicine Herbal Sachet OTHER

Each 100-g sachet contained powdered Suan Zao Ren, Cao Jue Ming, Jiang Xiang, Ye Jiao Teng, Yuan Zhi, rose flower, jasmine flower, He Huan Pi, Mu Xiang, and Chen Xiang. The ingredients were powdered to 80-100 mesh, uniformly mixed, and sealed in a nonwoven inner bag with a linen outer bag. One sachet was used nightly for 8 weeks and replaced every 2 weeks.

Traditional Chinese Medicine Herbal Sachet

Placebo Herbal Sachet OTHER

Each 100-g placebo sachet contained Huo Xiang 15 g, Bai Zhi 15 g, Ge Gen 30 g, Che Qian Cao 18 g, and Fu Hai Shi 22 g. The ingredients were powdered to 80-100 mesh and packaged in the same manner as the experimental sachet. One sachet was used nightly for 8 weeks and replaced every 2 weeks.

Placebo Herbal Sachet

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 years or older.
• Athens Insomnia Scale (AIS) total score of 6 or higher.
• In generally good health or with a stable medical condition, with no major surgery, emergency event, or serious trauma during the previous 6 months.
• Able to remain at the same residential location throughout the study.
• No severe psychiatric disorder or cognitive impairment; able to read, write, and understand the study information; willing to participate and provide written informed consent.

You may not qualify if:

• Olfactory impairment or known allergy to any ingredient in the herbal or placebo sachets.
• Use of sedative-hypnotic medication, antipsychotic medication, Chinese herbal medicine, or proprietary Chinese medicine affecting sleep during the previous 2 weeks.
• Major medical or psychiatric illness, including severe cardiovascular or cerebrovascular disease, severe respiratory depression, or impaired liver or kidney function.

Sponsors & Collaborators

• Macao Polytechnic University: lead

Study Sites (1)

Baishan Elderly Apartment

Qingdao, Shandong, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants were randomized in a 1:1 ratio to receive either the traditional Chinese medicine herbal sachet or a placebo sachet for 8 weeks.

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 26, 2026
• Study Start: November 6, 2023
• Primary Completion: January 14, 2024
• Study Completion: January 14, 2024
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

CN (1)