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Traditional Chinese Medicine Herbal Sachet for Insomnia in Older Adults

NCT07788547 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-08-26

No results posted yet for this study

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

Interventions

OTHER

Traditional Chinese Medicine Herbal Sachet

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.

OTHER

Placebo Herbal Sachet

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.

Sponsors & Collaborators

  • Macao Polytechnic University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2024-01-14
Completion
2024-01-14

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788547 on ClinicalTrials.gov