Sleep Initiation and Maintenance DisordersNCT07788547
Traditional Chinese Medicine Herbal Sachet for Insomnia in Older Adults
A study testing Traditional Chinese Medicine Herbal Sachet in people with Sleep Initiation and Maintenance Disorders, run by Macao Polytechnic University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Traditional Chinese Medicine Herbal Sachet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2023to 14 Jan 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Traditional Chinese Medicine Herbal Sachet on Sleep in Older Adults With Insomnia: A Randomized, Single-Blind, Placebo-Controlled Trial
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
Read the detailed description
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.
- Being tested
- Traditional Chinese Medicine Herbal Sachet, Placebo Herbal Sachet
- Keywords
- Insomnia, Older Adults, Traditional Chinese Medicine, Chinese Herbal Sachet, Aromatherapy, Sleep Quality, Long-Term Care Facilities
- 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine Herbal Sachet | Experimental | Participants received usual sleep-related care plus a 100-g compound traditional Chinese medicine herbal sachet. The sachet was placed beside the pillow within 30 cm of the participant's head from 7:00 p.m. to 8:00 a.m. every night for 8 weeks. Sachets were collected and sealed each morning and replaced every 2 weeks. Receives: Other: Traditional Chinese Medicine Herbal Sachet |
| Placebo Herbal Sachet | Placebo comparator | Participants received the same usual sleep-related care and schedule using a 100-g placebo herbal sachet. The placebo sachet had the same packaging as the experimental sachet but contained a different herbal mixture considered not to affect sleep. Sachets were placed within 30 cm of the participant's head from 7:00 p.m. to 8:00 a.m. every night for 8 weeks and replaced every 2 weeks. Receives: Other: Placebo Herbal Sachet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1), Day 28, and Day 56
Secondary outcomes (1)
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.
Measured: Baseline before intervention, Day 28, and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start6 Nov 2023
- Primary completion14 Jan 2024
- Study completion14 Jan 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
- Model description
- Participants were randomized in a 1:1 ratio to receive either the traditional Chinese medicine herbal sachet or a placebo sachet for 8 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788547
- Sponsor's protocol ID
- FCSD/MSN-0075/2023
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Traditional Chinese Medicine Herbal Sachet on Sleep in Older Adults With Insomnia: A Randomized, Single-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07788547
- Acronym / sponsor ID
- FCSD/MSN-0075/2023
- Keywords
- Insomnia, Older Adults, Traditional Chinese Medicine, Chinese Herbal Sachet, Aromatherapy, Sleep Quality, Long-Term Care Facilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Macao Polytechnic UniversityUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 14 Jan 2024 (actual)
- Study completion
- 14 Jan 2024 (actual)
- First posted
- 26 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.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to receive either the traditional Chinese medicine herbal sachet or a placebo sachet for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine Herbal Sachet | Experimental | Other: Traditional Chinese Medicine Herbal SachetParticipants received usual sleep-related care plus a 100-g compound traditional Chinese medicine herbal sachet. The sachet was placed beside the pillow within 30 cm of the participant's head from 7:00 p.m. to 8:00 a.m. every night for 8 weeks. Sachets were collected and sealed each morning and replaced every 2 weeks. |
| Placebo Herbal Sachet | Placebo comparator | Other: Placebo Herbal SachetParticipants received the same usual sleep-related care and schedule using a 100-g placebo herbal sachet. The placebo sachet had the same packaging as the experimental sachet but contained a different herbal mixture considered not to affect sleep. Sachets were placed within 30 cm of the participant's head from 7:00 p.m. to 8:00 a.m. every night for 8 weeks and replaced every 2 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 Herbal SachetEach 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 | Traditional Chinese Medicine Herbal Sachet |
| Placebo Herbal SachetEach 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. | Other | Placebo Herbal Sachet |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI) Total Score
Time frame: Baseline (Day 1), Day 28, and Day 56
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.
1 secondary outcome
Athens Insomnia Scale (AIS) Total Score
Time frame: Baseline before intervention, Day 28, and Day 56
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 26 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Herbal Sachet in people with Sleep Initiation and Maintenance Disorders, run by Macao Polytechnic University at 1 site in China.
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 5 inclusion and 3 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 26 Aug 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 China. 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?
Pittsburgh Sleep Quality Index (PSQI) Total Score (time frame: Baseline (Day 1), Day 28, and Day 56). 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 26 Aug 2026.