Sleep DisturbancesNCT05212298
Effects of Herbal Sleep Formula on Patients With Insomnia and Tinnitus
A study testing The gel contains a mixture of glucose and maltodextrin, Herbal compound low-dose and Herbal compound high-dose in people with Sleep Disturbances and Tinnitus, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
This project is planned to collect non-dialysis adults who suffer from sleep and tinnitus disorders and refuse to take sleeping medicines in our hospital by random assignment and double-blind method. 120 adults were divided into 3 groups. 1. Control group: receive placebo treatment, once a day, four pills each time. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Sleep Disturbances, Tinnitus
- What is being tested?
- The gel contains a mixture of glucose and maltodextrin, Herbal compound low-dose and Herbal compound high-dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2021to 31 Jan 2026
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20~70 years old
- Non-dialysis patients
- Suffering from sleep disorders and tinnitus
- Refuse to take sleeping pills
Who cannot join
- Patients who are bedridden or unable to take care of themselves.
- dialysis patients.
- Patients who cannot understand the details of this study or cannot cooperate with the examination.
- History of alcohol or drug abuse.
- Pregnant and lactating women
- Patients with moderate to severe sleep apnea
- Take sleeping pills
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Chiayi City, 66247
About this study
Official title: Effects of Herbal Sleep Formula on Patients With Insomnia and Tinnitus: Prospective, Randomized, Double-blinded Clinical Trial
This project is planned to collect non-dialysis adults who suffer from sleep and tinnitus disorders and refuse to take sleeping medicines in our hospital by random assignment and double-blind method.
120 adults were divided into 3 groups.
Read more
- Control group: receive placebo treatment, once a day, four pills each time.
- Herbal compound low-dose group: once a day, two herbal compound capsules and two placebos each time. The total amount of herbal compound capsules is 582 mg.
- Herbal compound high-dose group: once a day, four capsules each time. The total amount of herbal compound capsules is 1164 mg.
All subjects received health questionnaire, sleep questionnaire and tinnitus questionnaire before the start of the test At the end of the treatment(3 months), the health questionnaire, sleep questionnaire, and tinnitus questionnaire were accepted.
Read the detailed description
Sleep disturbances were very popular in general population. The prevalence of sleep disturbances were about 20 ~30% in adults. Insomnia is a complex disease with many etiologies. For example, pressure from daily activity, psychiatric diseases, and organic diseases may contribute to sleep disturbances. Besides, insomnia often comorbid comorbidly with tinnitus, and form a vicious cycle between insomnia and tinnitus. In the aspect of treatment, besides psychological treatment, insomnia was often treated with hypnotics. Variable types of GABA agonists and/or antidepression agents, including selective serotonin reuptake inhibitor (SSRI) were often used for insomnia. However, the medical treatments for insomnia patients were unsatisfactory, and many patients search for traditional Chinese medicine and/or herbal medicine.
Tinnitus can be defined as a phantom auditory perception in the absence of an external sound source. It is a common auditory symptom with a prevalence ranges from 4.6% in a survey study in Iranian population to 25.3% in a nationally representative survey in the United States, depending on the definition of tinnitus and study populations. A recent nationwide survey of the general population of South Korea reported that the prevalence of any tinnitus was 20.7% among adults aged 20 to 98 years. The prevalence was higher in women and it increased with age. A cohort study in England indicated that the incidence of clinically significant tinnitus was 5.4 cases per 10,000 person-years.
Tinnitus can severely interfere with activities of daily living, with common comorbidities such as anxiety, irritability, depression, inability to concentration, and sleep disturbances. Studies based on both questionnaires and polysomnography reported that sleep disturbance are common in patients with tinnitus. Recently, the investigators found that the risk of tinnitus was increased in middle-aged and elderly patients with sleep disturbance and/or sleep apnea. In the aspect of treatment, GABA agonists were often used to for tinnitus, but the results are still unsatisfactory till now.
Since many years ago, traditional Chinese medicine or herbal medicine had take care of insomnia and tinnitus. Some herbal foods and/or drugs, for example Lemon Balm Extract、Rice bran fermentation extract (GABA)、L-Tryptophan, were suggested for these two diseases with various results. In this study ,the investigators aimed to investigate the effects of herbal sleep formula on the sleep and tinnitus of patients without hemodialysis or peritoneal dialysis.
This project is planned to collect non-dialysis adults who suffer from sleep and tinnitus disorders and refuse to take sleeping medicines in our hospital by random assignment and double-blind method.
120 adults were divided into 3 groups.
- Control group: receive placebo treatment, once a day, four pills each time.
- Herbal compound low-dose group: once a day, two herbal compound capsules and two placebos each time. The total amount of herbal compound capsules is 582 mg.
- Herbal compound high-dose group: once a day, four capsules each time. The total amount of herbal compound capsules is 1164 mg.
All subjects received health questionnaire, sleep questionnaire and tinnitus questionnaire before the start of the test At the end of the treatment(3 months), the health questionnaire, sleep questionnaire, and tinnitus questionnaire were accepted.
- Conditions
- Sleep Disturbances, Tinnitus
- Being tested
- The gel contains a mixture of glucose and maltodextrin, Herbal compound low-dose, Herbal compound high-dose
- Medical subject headings
- Parasomnias, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The gel contains a mixture of glucose and maltodextrinDietary supplement
The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.
Herbal compound low-doseDietary supplement
The total amount of herbal compound capsules is 582 mg.
Herbal compound high-doseDietary supplement
The total amount of herbal compound capsules is 1164 mg.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | receive placebo treatment, once a day, four pills each time. Receives: Dietary Supplement: The gel contains a mixture of glucose and maltodextrin |
| Herbal compound low-dose | Experimental | once a day, two herbal compound capsules and two placebos each time. The total amount of herbal compound capsules is 582 mg. Receives: Dietary Supplement: Herbal compound low-dose |
| Herbal compound high-dose | Experimental | once a day, four capsules each time. The total amount of herbal compound capsules is 1164 mg. Receives: Dietary Supplement: Herbal compound high-dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each aspect has a minimum score of 0 and a maximum of 3 points. The total score range is 0-21 points. When the PSQI score is greater than 5 points, it indicates that there is a sleep quality disorder. The higher the score, the worse the sleep quality.
Measured: 3 month
Tinnitus Handicap Inventory
The Tinnitus Handicap Inventory (THI) comprises 25 items grouped into three subscales: Functional, Emotional, and Catastrophic. The Functional subscale (11 items) deals with limitations caused by tinnitus in the areas of mental, social, and physical functioning. The Emotional subscale (9 items) concerns affective responses to tinnitus, e.g. anger, frustration, depression, anxiety. The Catastrophic subscale (5 items) probes the most severe reactions to tinnitus, such as loss of control, inability to escape from tinnitus, and fear of having a terrible disease. For each item a patient can respond with a "yes" (scored 4 points), "sometimes" (2 points), or "no" (0 points). The responses are summed within each subscale and for the total scale. The higher the score, the greater the perceived tinnitus severity.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start16 Sep 2021
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbancesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juen-Haur Hwang, MD, PhD., Study chair, Dalin Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212298
- Sponsor's protocol ID
- A10804001-4
- Status last verified
- Feb 2026
- First submitted
- 27 Aug 2021
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Herbal Sleep Formula on Patients With Insomnia and Tinnitus: Prospective, Randomized, Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT05212298
- Acronym / sponsor ID
- A10804001-4
- Conditions
- Sleep Disturbances, Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 28 Jan 2022 (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.
This project is planned to collect non-dialysis adults who suffer from sleep and tinnitus disorders and refuse to take sleeping medicines in our hospital by random assignment and double-blind method.
120 adults were divided into 3 groups.
- Control group: receive placebo treatment, once a day, four pills each time.
- Herbal compound low-dose group: once a day, two herbal compound capsules and two placebos each time. The total amount of herbal compound capsules is 582 mg.
- Herbal compound high-dose group: once a day, four capsules each time. The total amount of herbal compound capsules is 1164 mg.
All subjects received health questionnaire, sleep questionnaire and tinnitus questionnaire before the start of the test At the end of the treatment(3 months), the health questionnaire, sleep questionnaire, and tinnitus questionnaire were accepted.
Detailed description
Sleep disturbances were very popular in general population. The prevalence of sleep disturbances were about 20 ~30% in adults. Insomnia is a complex disease with many etiologies. For example, pressure from daily activity, psychiatric diseases, and organic diseases may contribute to sleep disturbances. Besides, insomnia often comorbid comorbidly with tinnitus, and form a vicious cycle between insomnia and tinnitus. In the aspect of treatment, besides psychological treatment, insomnia was often treated with hypnotics. Variable types of GABA agonists and/or antidepression agents, including selective serotonin reuptake inhibitor (SSRI) were often used for insomnia. However, the medical treatments for insomnia patients were unsatisfactory, and many patients search for traditional Chinese medicine and/or herbal medicine.
Tinnitus can be defined as a phantom auditory perception in the absence of an external sound source. It is a common auditory symptom with a prevalence ranges from 4.6% in a survey study in Iranian population to 25.3% in a nationally representative survey in the United States, depending on the definition of tinnitus and study populations. A recent nationwide survey of the general population of South Korea reported that the prevalence of any tinnitus was 20.7% among adults aged 20 to 98 years. The prevalence was higher in women and it increased with age. A cohort study in England indicated that the incidence of clinically significant tinnitus was 5.4 cases per 10,000 person-years.
Tinnitus can severely interfere with activities of daily living, with common comorbidities such as anxiety, irritability, depression, inability to concentration, and sleep disturbances. Studies based on both questionnaires and polysomnography reported that sleep disturbance are common in patients with tinnitus. Recently, the investigators found that the risk of tinnitus was increased in middle-aged and elderly patients with sleep disturbance and/or sleep apnea. In the aspect of treatment, GABA agonists were often used to for tinnitus, but the results are still unsatisfactory till now.
Since many years ago, traditional Chinese medicine or herbal medicine had take care of insomnia and tinnitus. Some herbal foods and/or drugs, for example Lemon Balm Extract、Rice bran fermentation extract (GABA)、L-Tryptophan, were suggested for these two diseases with various results. In this study ,the investigators aimed to investigate the effects of herbal sleep formula on the sleep and tinnitus of patients without hemodialysis or peritoneal dialysis.
This project is planned to collect non-dialysis adults who suffer from sleep and tinnitus disorders and refuse to take sleeping medicines in our hospital by random assignment and double-blind method.
120 adults were divided into 3 groups.
- Control group: receive placebo treatment, once a day, four pills each time.
- Herbal compound low-dose group: once a day, two herbal compound capsules and two placebos each time. The total amount of herbal compound capsules is 582 mg.
- Herbal compound high-dose group: once a day, four capsules each time. The total amount of herbal compound capsules is 1164 mg.
All subjects received health questionnaire, sleep questionnaire and tinnitus questionnaire before the start of the test At the end of the treatment(3 months), the health questionnaire, sleep questionnaire, and tinnitus questionnaire were accepted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: The gel contains a mixture of glucose and maltodextrinreceive placebo treatment, once a day, four pills each time. |
| Herbal compound low-dose | Experimental | Dietary Supplement: Herbal compound low-doseonce a day, two herbal compound capsules and two placebos each time. The total amount of herbal compound capsules is 582 mg. |
| Herbal compound high-dose | Experimental | Dietary Supplement: Herbal compound high-doseonce a day, four capsules each time. The total amount of herbal compound capsules is 1164 mg. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20~70 years old
- Non-dialysis patients
- Suffering from sleep disorders and tinnitus
- Refuse to take sleeping pills
Key exclusion criteria (7 listed)
- Patients who are bedridden or unable to take care of themselves.
- dialysis patients.
- Patients who cannot understand the details of this study or cannot cooperate with the examination.
- History of alcohol or drug abuse.
- Pregnant and lactating women
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 |
|---|---|---|
| The gel contains a mixture of glucose and maltodextrinThe gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein. | Dietary supplement | Control |
| Herbal compound low-doseThe total amount of herbal compound capsules is 582 mg. | Dietary supplement | Herbal compound low-dose |
| Herbal compound high-doseThe total amount of herbal compound capsules is 1164 mg. | Dietary supplement | Herbal compound high-dose |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: 3 month
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each aspect has a minimum score of 0 and a maximum of 3 points. The total score range is 0-21 points. When the PSQI score is greater than 5 points, it indicates that there is a sleep quality disorder. The higher the score, the worse the sleep quality.
Tinnitus Handicap Inventory
Time frame: 3 month
The Tinnitus Handicap Inventory (THI) comprises 25 items grouped into three subscales: Functional, Emotional, and Catastrophic. The Functional subscale (11 items) deals with limitations caused by tinnitus in the areas of mental, social, and physical functioning. The Emotional subscale (9 items) concerns affective responses to tinnitus, e.g. anger, frustration, depression, anxiety. The Catastrophic subscale (5 items) probes the most severe reactions to tinnitus, such as loss of control, inability to escape from tinnitus, and fear of having a terrible disease. For each item a patient can respond with a "yes" (scored 4 points), "sometimes" (2 points), or "no" (0 points). The responses are summed within each subscale and for the total scale. The higher the score, the greater the perceived tinnitus severity.
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 4 Feb 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.
Juen-Haur Hwang, MD, PhD. study chair
Dalin Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The gel contains a mixture of glucose and maltodextrin, Herbal compound low-dose and Herbal compound high-dose in people with Sleep Disturbances and Tinnitus, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
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 4 inclusion and 7 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 4 Feb 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 Taiwan. 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 (time frame: 3 month). The study lists 2 primary outcomes in all. 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 4 Feb 2026.