Sleep DisorderNCT06279312
The Effect of Adaptogen Elixir on Sleep Improvement
A study testing Adaptogen Elixir drink in people with Sleep Disorder and Anxiety Disorders, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
This study aims to examine the effectiveness of Adaptogen Elixir herbal drink in relieving emotions and improving sleep quality. Participants will be randomly assigned to either the placebo group or the Adaptogen Elixir herbal drink group, with 25 participants in each group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, Anxiety Disorders
- What is being tested?
- Adaptogen Elixir drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Feb 2024to 1 Apr 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged above 18 years old.
- Individuals experiencing insomnia issues (PSQI > 5) or high levels of anxiety (GAD-7 > 9).
- No medication use or regular use of sleeping pills or antidepressants in the past month.
- No ongoing mental illnesses.
- No ongoing physical illnesses.
- No other sleep disorders.
- No circadian rhythm issues.
- No consumption of sleep or stress-related supplements in the past month.
Who cannot join
- Pregnant or breastfeeding women.
- Individuals with significant organic diseases such as organ transplants, epilepsy or seizures, liver or kidney diseases, malignant tumors, endocrine disorders, or a history of alcohol or substance use disorders.
- Individuals known to be allergic to any components of the product.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to examine the effectiveness of Adaptogen Elixir herbal drink in relieving emotions and improving sleep quality. Participants will be randomly assigned to either the placebo group or the Adaptogen Elixir herbal drink group, with 25 participants in each group. On the day of the experiment (week 0), participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. Subsequently, participants will be given the experimental samples and instructed to consume them continuously for 4 weeks following the instruction. Follow-up assessments will be conducted in the 2nd and 4th weeks, participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions.
- Conditions
- Sleep Disorder, Anxiety Disorders
- Being tested
- Placebo drink, Adaptogen Elixir drink
- Keywords
- Adaptogen
- Medical subject headings
- Sleep Wake Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo drinkDietary supplement
consume 1 drink per day for 4 weeks
Adaptogen Elixir drinkDietary supplement
Also called Isagenix-Adaptogen Elixir
consume 1 drink per day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo drink | Placebo comparator | consume 1 drink per day for 4 weeks Receives: Dietary Supplement: Placebo drink |
| Adaptogen Elixir drink | Experimental | consume 1 drink per day for 4 weeks Receives: Dietary Supplement: Adaptogen Elixir drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep monitoring
The difference of electrocardiosignal between two specific points on the body surface will be used to reflect sleep state.
Measured: Week 0 (Baseline), Week 2, Week 4
Sleeping qualityy
The Pittsburgh Sleep Quality Index (PSQI) will be utilized to assess sleeping quality. The minimum value is 0, the maximum value is 42. The higher the score, the worse the outcome.
Measured: Week 0 (Baseline), Week 2, Week 4
Sleeping disorders
Insomnia Severity Index (ISI) will be utilized to assess sleeping disorders. The minimum value is 0, the maximum value is 28. The higher the score, the worse the outcome.
Measured: Week 0 (Baseline), Week 2, Week 4
Secondary outcomes (4)
Neuropeptide Y concentration
Venous blood samples will be collected to measure concentrations of Neuropeptide Y.
Measured: Week 0 (Baseline), Week 2, Week 4
Cortisol concentration
Saliva samples will be collected to measure concentrations of cortisol.
Measured: Week 0 (Baseline), Week 2, Week 4
Anxiety
Generalized Anxiety Disorder-7 (GAD-7) will be utilized to assess anxiety. The minimum value is 0, the maximum value is 21. The higher the score, the worse the outcome.
Measured: Week 0 (Baseline), Week 2, Week 4
Low Frequency/High Frequence (LF/HF) ratio
A sleep monitoring system will be utilized to measure LF/HF ratio
Measured: Week 0 (Baseline), Week 2, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start26 Feb 2024
- Primary completion31 Jul 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hsin-Chien Lee, Doctor, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279312
- Sponsor's protocol ID
- N202311065
- Status last verified
- Apr 2025
- First submitted
- 19 Feb 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adaptogen Elixir on Sleep Improvement
- ClinicalTrials.gov ID
- NCT06279312
- Acronym / sponsor ID
- N202311065
- Conditions
- Sleep Disorder, Anxiety Disorders
- Keywords
- Adaptogen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 28 Feb 2024 (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 study aims to examine the effectiveness of Adaptogen Elixir herbal drink in relieving emotions and improving sleep quality. Participants will be randomly assigned to either the placebo group or the Adaptogen Elixir herbal drink group, with 25 participants in each group. On the day of the experiment (week 0), participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. Subsequently, participants will be given the experimental samples and instructed to consume them continuously for 4 weeks following the instruction. Follow-up assessments will be conducted in the 2nd and 4th weeks, participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo drinkconsume 1 drink per day for 4 weeks |
| Adaptogen Elixir drink | Experimental | Dietary Supplement: Adaptogen Elixir drinkconsume 1 drink per day for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged above 18 years old.
- Individuals experiencing insomnia issues (PSQI > 5) or high levels of anxiety (GAD-7 > 9).
- No medication use or regular use of sleeping pills or antidepressants in the past month.
- No ongoing mental illnesses.
- No ongoing physical illnesses.
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding women.
- Individuals with significant organic diseases such as organ transplants, epilepsy or seizures, liver or kidney diseases, malignant tumors, endocrine disorders, or a history of alcohol or substance use disorders.
- Individuals known to be allergic to any components of the product.
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 |
|---|---|---|
| Placebo drinkconsume 1 drink per day for 4 weeks | Dietary supplement | Placebo drink |
| Adaptogen Elixir drinkAlso: Isagenix-Adaptogen Elixirconsume 1 drink per day for 4 weeks | Dietary supplement | Adaptogen Elixir drink |
Primary outcome
Sleep monitoring
Time frame: Week 0 (Baseline), Week 2, Week 4
The difference of electrocardiosignal between two specific points on the body surface will be used to reflect sleep state.
Sleeping qualityy
Time frame: Week 0 (Baseline), Week 2, Week 4
The Pittsburgh Sleep Quality Index (PSQI) will be utilized to assess sleeping quality. The minimum value is 0, the maximum value is 42. The higher the score, the worse the outcome.
Sleeping disorders
Time frame: Week 0 (Baseline), Week 2, Week 4
Insomnia Severity Index (ISI) will be utilized to assess sleeping disorders. The minimum value is 0, the maximum value is 28. The higher the score, the worse the outcome.
4 secondary outcomes
Neuropeptide Y concentration
Time frame: Week 0 (Baseline), Week 2, Week 4
Cortisol concentration
Time frame: Week 0 (Baseline), Week 2, Week 4
Anxiety
Time frame: Week 0 (Baseline), Week 2, Week 4
Low Frequency/High Frequence (LF/HF) ratio
Time frame: Week 0 (Baseline), Week 2, Week 4
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 11 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Hsin-Chien Lee, Doctor principal investigator
Taipei Medical 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 Adaptogen Elixir drink in people with Sleep Disorder and Anxiety Disorders, run by TCI Co., Ltd. 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 8 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 11 Apr 2025. 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?
Sleep monitoring (time frame: Week 0 (Baseline), Week 2, Week 4). The study lists 3 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 11 Apr 2025.