SchizophreniaNCT01167348
The Effectiveness Of Auricular Acupressure On Body Weight Parameters On Patients With Schizophrenia
A study testing auricular acupressure in people with Schizophrenia and Obesity, run by TsaoTun Psychiatric Center, Department of Health, Taiwan at 1 site in Taiwan.
Trial summary
The purpose of this study is to examine whether auricular acupressure is effective in reducing body weight, waist circumference, or lipid profile. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Schizophrenia, Obesity
- What is being tested?
- auricular acupressure
- Type of treatment
- Surgery or procedure
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2010to Aug 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ICD:295,living in chronic ward for more than 2 month
- Body Mass Index (BMI) >or=24
- Age between 20 to 60
- Psychotic status stable and can communicate
Who cannot join
- Unstable psychotic status
- Participants who have endocrine disease
- Participants who have cardiac disease
- Participants who have immunological disease
- Participants who have liver or renal function impairment
- Pregnant woman or in milking stage
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- Cerebrovascular accident (CVA) stroke and disability
- Participant who attends weight control programs in recent 3 months
- Any conditions that clinical doctors refuse to let join in this study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tsao-Tun Psychiatric Center
Nantou City
Han-Yi Ching, MD, 886911587276, HYChing@mail.ttpc.doh.gov.tw
About this study
The purpose of this study is to examine whether auricular acupressure is effective in reducing body weight, waist circumference, or lipid profile.
- Conditions
- Schizophrenia, Obesity
- Being tested
- auricular acupressure
- Keywords
- auricular acupressure, obesity, schizophrenia, body weight
- Medical subject headings
- Schizophrenia, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular acupressureProcedure or surgery
Investigator will put a tape with a 0.5mmx0.5mm seed on the specific positions on the ear of participants of intervention group, and participants will be asked to press these specific positions 3 times a day.
What is being measured
The primary outcome is the main question the study is designed to answer.
Using Body weight scale (kilogram) and checking body weight for all participants
all participants are going to be measured body weight per week for 2 months.
Measured: 2 months
Secondary outcomes (2)
waist circumference
All participants are going to be measured waist circumference per week for 2 months.
Measured: 2 months
Fat percentage by using bio-Impedance Analysis(Tanita-519 machine)
All participants will be measured fat percentage by BIA(Tanita-519) per 2 months.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TsaoTun Psychiatric Center, Department of Health, Taiwan
- Sponsor type
- University, hospital or other
- Investigators
- Ching Han-Yi, MD, Principal investigator, Tsaotun Psychiatric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167348
- Sponsor's protocol ID
- Tsaotun Psychiatric Center
- Status last verified
- Jul 2010
- First submitted
- 16 Jul 2010
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness Of Auricular Acupressure On Body Weight Parameters On Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01167348
- Acronym / sponsor ID
- Tsaotun Psychiatric Center
- Conditions
- Schizophrenia, Obesity
- Keywords
- auricular acupressure, obesity, schizophrenia, body weight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- TsaoTun Psychiatric Center, Department of Health, TaiwanUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 22 Jul 2010 (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.
The purpose of this study is to examine whether auricular acupressure is effective in reducing body weight, waist circumference, or lipid profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ICD:295,living in chronic ward for more than 2 month
- Body Mass Index (BMI) >or=24
- Age between 20 to 60
- Psychotic status stable and can communicate
Key exclusion criteria (9 listed)
- Unstable psychotic status
- Participants who have endocrine disease
- Participants who have cardiac disease
- Participants who have immunological disease
- Participants who have liver or renal function impairment
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 |
|---|---|---|
| auricular acupressureInvestigator will put a tape with a 0.5mmx0.5mm seed on the specific positions on the ear of participants of intervention group, and participants will be asked to press these specific positions 3 times a day. | Procedure or surgery | – |
Primary outcome
Using Body weight scale (kilogram) and checking body weight for all participants
Time frame: 2 months
all participants are going to be measured body weight per week for 2 months.
2 secondary outcomes
waist circumference
Time frame: 2 months
Fat percentage by using bio-Impedance Analysis(Tanita-519 machine)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
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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.
Ching Han-Yi, MD principal investigator
Tsaotun Psychiatric Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auricular acupressure in people with Schizophrenia and Obesity, run by TsaoTun Psychiatric Center, Department of Health, Taiwan 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 9 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: status not confirmed, as of the sponsor's last update on 23 Jul 2010. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han-Yi Ching, MD (886911587276, HYChing@mail.ttpc.doh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Using Body weight scale (kilogram) and checking body weight for all participants (time frame: 2 months). 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 23 Jul 2010.