InsomniaPhase 2NCT02319993
Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia.
A Phase 2 study testing TIAN WANG BU XIN DAN and Suan Tzao Ren Tang in people with Insomnia, run by Chung Shan Medical University.
Trial summary
keywords： Traditional Chinese Medicine, Herbs, Clinical trial, Insomnia, Quality of life, Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Insomnia
- What is being tested?
- TIAN WANG BU XIN DAN and Suan Tzao Ren Tang
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Oct 2014
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insomnia disorders in patients 20-80 years of age, the Pittsburgh Sleep Assessment Scale (PSQI)> 6 points.
- No insomnia caused by other diseases. For example: mental illness (depression, etc.), sleep apnea, heart disease (acute myocardial infarction, heart rate is not the whole), hypertension, diabetes, cancer and so on.
- There are more than a week (including) three times to be more than 30 minutes to fall asleep and sleep less than six hours, there is a continuous months.
- Test subjects had to really understand the nature of this study, and participants signed consent.
Who cannot join
- Before participating in this study, three months, had a major accident or wheel graveyard shift or jet lag problems (such as a long flight).
- Any insomnia caused by other diseases. For example: mental illness (depression, etc.), sleep apnea, heart disease (acute myocardial infarction), poorly controlled hypertension (> 140 / 90mmHg), poorly controlled diabetes (HbA1C> 7%), cancer, digestive ulcers (undergoing treatment).
- 2 weeks into the experiment of taking melatonin or melatonin agonist, acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, prostaglandins and other drugs.
- If patients sleep disorders arise from nighttime urinary frequency. Pregnant or breastfeeding person.
- Patients unable to read and fill out the questionnaire by themselves this study.
About this study
Official title: Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia. A Multi-center Clinical Trial
keywords： Traditional Chinese Medicine, Herbs, Clinical trial, Insomnia, Quality of life, Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan
Read the detailed description
Title： Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in patients with primary insomnia. A multi-center, double blind, placebo controlled clinical trial.
(First year of two-years' project)
Design:
Randomized, placebo-controlled trial comprising 3 arms: SZRT, placebo, TWBXD.
Setting:
The Chung Shan Medical University Affiliated Hospital and the Taipei City Hospital.
Methods:
A total of 128 subjects 20-80 years of age with a history of insomnia at least 1 month were recruited randomly assigned to SZRT (n = 48), placebo (n =32), TWBXD (n =48) and were instructed to take 6 gm 2 times per day of SZRT, TWBXD or placebo for a period of 4 weeks. The primary outcome measures were the mean component scores of the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome parameter were the global score on the World Health Organization Quality of Life questionnaire - Taiwan brief version, drugs consumption counts, sleep diary and safety profiles by structures questionnaires.
- Conditions
- Insomnia
- Being tested
- TIAN WANG BU XIN DAN, Suan Tzao Ren Tang, Placebo
- Keywords
- Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan, Traditional Chinese Medicine, Herbs, Quality of life
- 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.
TIAN WANG BU XIN DANDrug
Also called TWBXD
assigned to TWBXD (n =48) and were instructed to take 6 gm 2 times per day of TWBXD for a period of 4 weeks.
Suan Tzao Ren TangDrug
Also called STRT
assigned to SZRT (n = 48) and were instructed to take 6 gm 2 times per day of SZRT for a period of 4 weeks.
PlaceboDrug
Also called P
1/10 TIAN WANG BU XIN DAN assigned to placebo (n =32) and were instructed to take 6 gm 2 times per day of placebo for a period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TIAN WANG BU XIN DAN | Experimental | Drug:TIAN WANG BU XIN DAN CONCENRATED GRANULES "CHUANG SONG ZONG" Receives: Drug: TIAN WANG BU XIN DAN |
| Suan Tzao Ren Tang | Experimental | Drug:Suan Tzao Ren Tang Granula Subtilae "CHUANG SONG ZONG" Receives: Drug: Suan Tzao Ren Tang |
| Placebo | Placebo comparator | Drug:1/10 TIAN WANG BU XIN DAN Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
Measured: 4 weeks
Secondary outcomes (1)
World Health Organization Quality of Life questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GCRC, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319993
- Sponsor's protocol ID
- CSH-CMCTC-101-001
- Status last verified
- Jan 2016
- First submitted
- 14 Dec 2014
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia. A Multi-center Clinical Trial
- ClinicalTrials.gov ID
- NCT02319993
- Acronym / sponsor ID
- CSH-CMCTC-101-001
- Conditions
- Insomnia
- Keywords
- Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan, Traditional Chinese Medicine, Herbs, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Dec 2014 (estimated)
- 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.
keywords： Traditional Chinese Medicine, Herbs, Clinical trial, Insomnia, Quality of life, Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan
Detailed description
Title： Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in patients with primary insomnia. A multi-center, double blind, placebo controlled clinical trial.
(First year of two-years' project)
Design:
Randomized, placebo-controlled trial comprising 3 arms: SZRT, placebo, TWBXD.
Setting:
The Chung Shan Medical University Affiliated Hospital and the Taipei City Hospital.
Methods:
A total of 128 subjects 20-80 years of age with a history of insomnia at least 1 month were recruited randomly assigned to SZRT (n = 48), placebo (n =32), TWBXD (n =48) and were instructed to take 6 gm 2 times per day of SZRT, TWBXD or placebo for a period of 4 weeks. The primary outcome measures were the mean component scores of the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome parameter were the global score on the World Health Organization Quality of Life questionnaire - Taiwan brief version, drugs consumption counts, sleep diary and safety profiles by structures questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TIAN WANG BU XIN DAN | Experimental | Drug: TIAN WANG BU XIN DANDrug:TIAN WANG BU XIN DAN CONCENRATED GRANULES "CHUANG SONG ZONG" |
| Suan Tzao Ren Tang | Experimental | Drug: Suan Tzao Ren TangDrug:Suan Tzao Ren Tang Granula Subtilae "CHUANG SONG ZONG" |
| Placebo | Placebo comparator | Drug: PlaceboDrug:1/10 TIAN WANG BU XIN DAN |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Insomnia disorders in patients 20-80 years of age, the Pittsburgh Sleep Assessment Scale (PSQI)> 6 points.
- No insomnia caused by other diseases. For example: mental illness (depression, etc.), sleep apnea, heart disease (acute myocardial infarction, heart rate is not the whole), hypertension, diabetes, cancer and so on.
- There are more than a week (including) three times to be more than 30 minutes to fall asleep and sleep less than six hours, there is a continuous months.
- Test subjects had to really understand the nature of this study, and participants signed consent.
Key exclusion criteria (5 listed)
- Before participating in this study, three months, had a major accident or wheel graveyard shift or jet lag problems (such as a long flight).
- Any insomnia caused by other diseases. For example: mental illness (depression, etc.), sleep apnea, heart disease (acute myocardial infarction), poorly controlled hypertension (> 140 / 90mmHg), poorly controlled diabetes (HbA1C> 7%), cancer, digestive ulcers (undergoing treatment).
- 2 weeks into the experiment of taking melatonin or melatonin agonist, acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, prostaglandins and other drugs.
- If patients sleep disorders arise from nighttime urinary frequency. Pregnant or breastfeeding person.
- Patients unable to read and fill out the questionnaire by themselves this study.
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 |
|---|---|---|
| TIAN WANG BU XIN DANAlso: TWBXDassigned to TWBXD (n =48) and were instructed to take 6 gm 2 times per day of TWBXD for a period of 4 weeks. | Drug | TIAN WANG BU XIN DAN |
| Suan Tzao Ren TangAlso: STRTassigned to SZRT (n = 48) and were instructed to take 6 gm 2 times per day of SZRT for a period of 4 weeks. | Drug | Suan Tzao Ren Tang |
| PlaceboAlso: P1/10 TIAN WANG BU XIN DAN assigned to placebo (n =32) and were instructed to take 6 gm 2 times per day of placebo for a period of 4 weeks. | Drug | Placebo |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4 weeks
1 secondary outcome
World Health Organization Quality of Life questionnaire
Time frame: 4 weeks
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 20 Jan 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TIAN WANG BU XIN DAN and Suan Tzao Ren Tang in people with Insomnia, run by Chung Shan Medical University.
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 5 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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) (time frame: 4 weeks). 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 20 Jan 2016.