Traditional Chinese Medicine Herbal Sachet for Insomnia in Older Adults

Macao Polytechnic University154 enrolled

Overview

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

This randomized, parallel-group, participant-blinded, placebo-controlled trial enrolled 154 adults aged 60 years or older with insomnia. Participants were allocated in a 1:1 ratio using a computer-generated random-number table and sequentially numbered, sealed, opaque envelopes. The active intervention was a 100-gram Traditional Chinese Medicine herbal sachet containing 10 powdered herbal ingredients. The formula was derived from an earlier expert-consensus development study. The placebo sachet contained five ingredients not expected to improve sleep and was designed to resemble the active sachet in size, weight, appearance, and texture. Participants placed the assigned sachet within 30 centimeters of the head from 7:00 p.m. until 8:00 a.m. each night for eight weeks. Sachets were replaced every two weeks and stored in sealed bags during the daytime. Both groups received the same routine sleep-related education and support. Insomnia symptoms and sleep quality were assessed at baseline, week 4, and week 8 using the Athens Insomnia Scale and Pittsburgh Sleep Quality Index. Adverse reactions, including allergic reactions and respiratory discomfort, were monitored throughout the intervention. The completed study was registered retrospectively.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Interventions

Traditional Chinese Medicine Herbal SachetOTHER

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.

Placebo Herbal SachetOTHER

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.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline (Day 1), Day 28, and Day 56

Secondary Outcomes

Athens Insomnia Scale (AIS) Total Score

The AIS contains 8 items scored from 0 to 3, producing a total score from 0 to 24. Higher scores indicate more severe insomnia symptoms. A total score of 6 or higher indicates insomnia.

Time frame: Baseline before intervention, Day 28, and Day 56