Skip to main content
OpenTrials
Completed

NCT Number: NCT07757724

Chinese Herbal Sachet Therapy for Sleep Quality in Menopausal Women

Many women sleep poorly during the menopausal transition. Some prefer not to take hormone therapy or sleeping tablets, and ask their nurses about other options. This study tested a traditional Chinese medicine aromatic sachet containing ten herbs, chosen by a panel of experts. Women placed the sachet beside their pillow each night for nine weeks and removed it each morning.

One hundred and twenty-two women aged 45 to 59 who reported poor sleep and were recruited in Macao took part. Half received the herbal sachet and half received a placebo sachet, which was identical in appearance, weight and packaging and carried a herbal scent, but did not contain the herbs being tested. Participants were not told which sachet they had been given. Sleep quality was measured using the Pittsburgh Sleep Quality Index at the start of the study and again after 3, 6 and 9 weeks.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Menopause Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

45 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Macao Polytechnic University

Macao, 999078, Macau

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 45 to 59 years; self-reported sleep disturbance during the menopausal transition with a baseline Pittsburgh Sleep Quality Index global score of at least 5; normal olfactory function; fluent in reading and writing Chinese; able to use a smartphone application for daily adherence logging; provided written informed consent.

Exclusion criteria

  • Severe systemic illness such as cancer or renal or hepatic failure; drug-induced insomnia; severe drug allergy history; acute respiratory illness; drug or alcohol dependence; secondary insomnia due to pain; pregnancy or lactation; current use of non-pharmacological sleep interventions such as acupuncture; current or newly initiated hormone replacement therapy, or unstable hypnotic medication use during the study period.

Treatment and study plan

Traditional Chinese medicine aromatic sachet

Other

Aromatic sachet containing Albizia flower 12 g, lavender 12 g, Acorus 5 g, rose 12 g, white chrysanthemum 12 g, Atractylodes 12 g, Angelica 12 g, mugwort 12 g, chuanxiong 7 g and cinnamon twig 7 g, 103 g total. Used nightly beside the pillow for nine weeks and replaced every three weeks.

Placebo aromatic sachet

Other

Odour-plausible placebo sachet containing Agastache rugosa, Angelica dahurica, Pueraria montana var. lobata, Plantago asiatica, pumice and Hibiscus sabdariffa, matched to the active sachet in appearance, weight and packaging. Used nightly beside the pillow for nine weeks and replaced every three weeks.

Primary outcomes

  1. Change in Pittsburgh Sleep Quality Index (PSQI) global score

    Time frame: Baseline, week 3, week 6, week 9

    The Pittsburgh Sleep Quality Index is a 19-item self-report instrument yielding seven component scores summed to a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality.

Secondary outcomes

  1. Proportion of participants with a PSQI global score of 5 or below

    Time frame: Baseline to week 9

    Proportion of participants achieving a PSQI global score of 5 or below, the conventional threshold for good sleep quality.

  2. Proportion of participants achieving a reduction of at least 3 points in PSQI global score

    Time frame: Baseline to week 9

    Proportion of participants whose PSQI global score decreased by at least 3 points from baseline, a commonly used marker of clinically meaningful improvement.

  3. Sleep Quality Improvement Index (SQII)

    Time frame: Baseline to week 9

    SQII was calculated by the Nimodipine method as (baseline PSQI - post-intervention PSQI) / baseline PSQI x 100%. Higher values indicate greater improvement in sleep quality.

Sponsors and collaborators

Lead sponsor

Macao Polytechnic University

Other

Registry information

Official study title

Effect of Chinese Herbal Sachet Therapy on Improving Sleep Quality of Midlife Women in Macao: A Randomized Placebo-Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.