Chinese Herbal Sachet Therapy for Sleep Quality in Menopausal Women

NCT07757724 | Completed

• 1 other identifier: RP/AE-03/2022
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Initiation and Maintenance Disorders; Menopause

Keywords

aromatherapy; traditional Chinese medicine; menopause; sleep quality; Pittsburgh Sleep Quality Index; nursing

Outcome Measures

Primary Outcomes (1)

• Change in Pittsburgh Sleep Quality Index (PSQI) global score

  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.

  Baseline, week 3, week 6, week 9

Secondary Outcomes (3)

• Proportion of participants with a PSQI global score of 5 or below

  Baseline to week 9

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

  Baseline to week 9

• Sleep Quality Improvement Index (SQII)

  Baseline to week 9

Study Arms (2)

TCM aromatic sachet

EXPERIMENTAL

Ten-herb traditional Chinese medicine aromatic sachet, 103 g total, in a non-woven inner bag (12 x 16 cm) inside a breathable linen outer bag (13 x 18 cm). Participants removed the sachet from a sealed plastic bag 15 minutes before bedtime, placed it within 30 cm of the pillow throughout the sleep period, and resealed it in the plastic bag on waking. The sachet was replaced every three weeks, for a total of nine weeks.

Other: Traditional Chinese medicine aromatic sachet

Placebo sachet

PLACEBO COMPARATOR

Placebo sachet identical to the active sachet in inner and outer bag, packaging, total weight, usage instructions and three-weekly replacement schedule, for a total of nine weeks. It contained Agastache rugosa, Angelica dahurica, Pueraria montana var. lobata, Plantago asiatica, pumice and Hibiscus sabdariffa, selected to give a plausible but non-identical herbal odour.

Other: Placebo aromatic sachet

Interventions

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.

TCM aromatic sachet

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.

Placebo sachet

Eligibility Criteria

• Age: 45 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Macao Polytechnic University: lead

Study Sites (1)

Macao Polytechnic University

Macao, Macao, 999078, Macau

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 Officials

• Cindy SIN U LEONG, DHSc, MHS, BSN, RN

  Macao Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not informed whether they received the active or placebo sachet. The research team was aware of group assignment, outcomes were self-reported, and blinding effectiveness was not assessed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: December 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)