Sleep Initiation and Maintenance DisordersNCT07757724
Chinese Herbal Sachet Therapy for Sleep Quality in Menopausal Women
A study testing Traditional Chinese medicine aromatic sachet in people with Sleep Initiation and Maintenance Disorders and Menopause, run by Macao Polytechnic University at 1 site in Macau.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 59 years, women only
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Menopause
- What is being tested?
- Traditional Chinese medicine aromatic sachet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteMacau
- Study dates
- 1 Dec 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 45 to 59 years
- Self-reported sleep disturbance during the menopausal transition
- Baseline Pittsburgh Sleep Quality Index (PSQI) global score of 5 or above
- Normal olfactory function
- Fluent in reading and writing Chinese
- Able to use a smartphone application for daily adherence logging
- Provided written informed consent
Who cannot join
- Severe systemic illness such as cancer or renal or hepatic failure
- Drug-induced insomnia
- History of severe drug allergy
- Acute respiratory illness
- Drug or alcohol dependence
- Secondary insomnia due to pain
Show all 10Show fewer
- Pregnancy or lactation
- Current use of non-pharmacological sleep interventions such as acupuncture
- Current or newly initiated hormone replacement therapy
- Unstable hypnotic medication use during the study period
Trial locations and contacts
1 site in 1 country.
Macau1 site
Macao Polytechnic University
Macao, Macao, 999078
About this study
Official title: Effect of Chinese Herbal Sachet Therapy on Improving Sleep Quality of Midlife Women in Macao: A Randomized Placebo-Controlled Trial
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.
Read the detailed description
This participant-blinded, randomized, placebo-controlled trial evaluated a Delphi-developed ten-herb traditional Chinese medicine aromatic sachet for self-reported sleep quality in community-dwelling menopausal women aged 45 to 59 years with a baseline Pittsburgh Sleep Quality Index (PSQI) global score of 5 or above. The formula was developed before recruitment through a three-round Delphi consensus with ten experts. Participants recruited through the study institution, two Macao community organisations and online channels were randomised 1:1 by computer-generated numbers to the active sachet or an odour-plausible placebo sachet identical in appearance, weight and packaging; participants were not told their allocation, while the research team was aware of it. Sachets were placed within 30 cm of the pillow nightly and replaced every three weeks for nine weeks; nightly adherence was logged through a WeChat check-in mini-program. The PSQI was completed at baseline and weeks 3, 6 and 9. The primary analysis used generalized estimating equations (normal distribution, identity link, exchangeable working correlation, robust standard errors) with group, time and group-by-time interaction, plus Mann-Whitney U comparisons at each timepoint; secondary outcomes were responder proportions (PSQI 5 or below; reduction of 3 or more points) and the Sleep Quality Improvement Index. Analyses were performed on the 112 participants who completed all four assessments (completer analysis). The trial was registered retrospectively after data collection was complete; the ethics approval (13 October 2023) and the pre-specified protocol predate enrolment (first participant December 2023).
- Being tested
- Traditional Chinese medicine aromatic sachet, Placebo aromatic sachet
- Keywords
- aromatherapy, traditional Chinese medicine, menopause, sleep quality, Pittsburgh Sleep Quality Index, nursing
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese medicine aromatic sachetOther
Aromatic sachet containing Albizia flower 12 g, lavender 12 g, Acorus (Acorus tatarinowii) 5 g, rose (Rosa rugosa) 12 g, white chrysanthemum 12 g, Atractylodes (Atractylodes lancea) 12 g, Angelica sinensis 12 g, mugwort 12 g, chuanxiong 7 g and cinnamon bark (Cinnamomi Cortex) 7 g, 103 g total, ground to powder and sealed in a non-woven inner bag (12 x 16 cm) inside a non-woven outer bag (13 x 18 cm). Used nightly within 30 cm of the pillow for nine weeks and replaced every three weeks.
Placebo aromatic sachetOther
Odour-plausible placebo sachet containing Agastache rugosa, Angelica dahurica, Pueraria montana var. lobata, Plantago asiatica and pumice, matched to the active sachet in appearance, weight and packaging. Used nightly beside the pillow for nine weeks and replaced every three weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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 non-woven 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. Receives: 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 and pumice, selected to give a plausible but non-identical herbal odour. Receives: Other: Placebo aromatic sachet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 3, week 6, week 9
Secondary outcomes (5)
Proportion of participants with a PSQI global score of 5 or below
Proportion of participants achieving a PSQI global score of 5 or below, the conventional threshold for good sleep quality.
Measured: Baseline to week 9
Proportion of participants achieving a reduction of at least 3 points in PSQI global score
Proportion of participants whose PSQI global score decreased by at least 3 points from baseline, a commonly used marker of clinically meaningful improvement.
Measured: Baseline to week 9
Sleep Quality Improvement Index (SQII)
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.
Measured: Baseline to week 9
Change in Greene Climacteric Scale (GCS) total score
The Greene Climacteric Scale is a 21-item self-report instrument. Each item is scored 0 to 3, giving a total score from 0 to 63. Higher scores indicate greater menopausal symptom burden.
Measured: Baseline, week 3, week 6, week 9
Change in Greene Climacteric Scale (GCS) symptom cluster scores
Cluster scores derived from the Greene Climacteric Scale: anxiety (items 1-6, range 0-18), depressive (items 7-11, range 0-15), somatic (items 12-18, range 0-21), vasomotor (items 19-20, range 0-6) and sexual function (item 21, range 0-3). Higher scores indicate greater symptom burden.
Measured: Baseline, week 3, week 6, week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Dec 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macao Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy Sin U Leong, Macao Polytechnic University
- Investigators
- Cindy Sin U LEONG, DHSc, RN, Principal investigator, Macao Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757724
- Sponsor's protocol ID
- RP/AE-03/2022
- Other IDs
- RP/AE-03/2022
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants did not consent to public release of individual participant data, and the ethics approval did not cover open data deposition. De-identified data may be considered on reasonable request to the corresponding author, subject to ethics committee approval.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chinese Herbal Sachet Therapy on Improving Sleep Quality of Midlife Women in Macao: A Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07757724
- Acronym / sponsor ID
- RP/AE-03/2022
- Keywords
- aromatherapy, traditional Chinese medicine, menopause, sleep quality, Pittsburgh Sleep Quality Index, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Macao Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This participant-blinded, randomized, placebo-controlled trial evaluated a Delphi-developed ten-herb traditional Chinese medicine aromatic sachet for self-reported sleep quality in community-dwelling menopausal women aged 45 to 59 years with a baseline Pittsburgh Sleep Quality Index (PSQI) global score of 5 or above. The formula was developed before recruitment through a three-round Delphi consensus with ten experts. Participants recruited through the study institution, two Macao community organisations and online channels were randomised 1:1 by computer-generated numbers to the active sachet or an odour-plausible placebo sachet identical in appearance, weight and packaging; participants were not told their allocation, while the research team was aware of it. Sachets were placed within 30 cm of the pillow nightly and replaced every three weeks for nine weeks; nightly adherence was logged through a WeChat check-in mini-program. The PSQI was completed at baseline and weeks 3, 6 and 9. The primary analysis used generalized estimating equations (normal distribution, identity link, exchangeable working correlation, robust standard errors) with group, time and group-by-time interaction, plus Mann-Whitney U comparisons at each timepoint; secondary outcomes were responder proportions (PSQI 5 or below; reduction of 3 or more points) and the Sleep Quality Improvement Index. Analyses were performed on the 112 participants who completed all four assessments (completer analysis). The trial was registered retrospectively after data collection was complete; the ethics approval (13 October 2023) and the pre-specified protocol predate enrolment (first participant December 2023).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM aromatic sachet | Experimental | Other: Traditional Chinese medicine aromatic sachetTen-herb traditional Chinese medicine aromatic sachet, 103 g total, in a non-woven inner bag (12 x 16 cm) inside a non-woven 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. |
| Placebo sachet | Placebo comparator | Other: Placebo aromatic sachetPlacebo 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 and pumice, selected to give a plausible but non-identical herbal odour. |
Who may qualify
- Ages
- 45 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 45 to 59 years
- Self-reported sleep disturbance during the menopausal transition
- Baseline Pittsburgh Sleep Quality Index (PSQI) global score of 5 or above
- Normal olfactory function
- Fluent in reading and writing Chinese
Key exclusion criteria (10 listed)
- Severe systemic illness such as cancer or renal or hepatic failure
- Drug-induced insomnia
- History of severe drug allergy
- Acute respiratory illness
- Drug or alcohol dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese medicine aromatic sachetAromatic sachet containing Albizia flower 12 g, lavender 12 g, Acorus (Acorus tatarinowii) 5 g, rose (Rosa rugosa) 12 g, white chrysanthemum 12 g, Atractylodes (Atractylodes lancea) 12 g, Angelica sinensis 12 g, mugwort 12 g, chuanxiong 7 g and cinnamon bark (Cinnamomi Cortex) 7 g, 103 g total, ground to powder and sealed in a non-woven inner bag (12 x 16 cm) inside a non-woven outer bag (13 x 18 cm). Used nightly within 30 cm of the pillow for nine weeks and replaced every three weeks. | Other | TCM aromatic sachet |
| Placebo aromatic sachetOdour-plausible placebo sachet containing Agastache rugosa, Angelica dahurica, Pueraria montana var. lobata, Plantago asiatica and pumice, matched to the active sachet in appearance, weight and packaging. Used nightly beside the pillow for nine weeks and replaced every three weeks. | Other | Placebo sachet |
Primary outcome
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.
5 secondary outcomes
Proportion of participants with a PSQI global score of 5 or below
Time frame: Baseline to week 9
Proportion of participants achieving a reduction of at least 3 points in PSQI global score
Time frame: Baseline to week 9
Sleep Quality Improvement Index (SQII)
Time frame: Baseline to week 9
Change in Greene Climacteric Scale (GCS) total score
Time frame: Baseline, week 3, week 6, week 9
Change in Greene Climacteric Scale (GCS) symptom cluster scores
Time frame: Baseline, week 3, week 6, week 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. Participants did not consent to public release of individual participant data, and the ethics approval did not cover open data deposition. De-identified data may be considered on reasonable request to the corresponding author, subject to ethics committee approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy Sin U LEONG, DHSc, RN principal investigator
Macao Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese medicine aromatic sachet in people with Sleep Initiation and Maintenance Disorders and Menopause, run by Macao Polytechnic University at 1 site in Macau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Macau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pittsburgh Sleep Quality Index (PSQI) global score (time frame: Baseline, week 3, week 6, week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.