Skin ItchingNCT00737451
Association of Thyroid Autoimmunity and Chronic Urticaria
An observational study of Skin Itching and Chronic Urticaria, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Increase prevalence of thyroid autoimmunity is found in patients with chronic urticaria. About 5-34% of chronic urticaria patients is associated with the presence of thyroid autoimmunity who are euthyroid status whereas 5-10% of them with either hyperthyroidism or hypothyroidism. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Itching, Chronic Urticaria
- What is being tested?
- blood sampling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 155 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2008to Nov 2010
- Phase
- Observational
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18 and above with complaint of skin itching
Who may be able to join
- 18 years old and above
- skin itching for more than 6 months
Who cannot join
- pure physical urticaria, infectious diseases, and food or food addictive hypersensitivity, chronic infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Thyroid Autoimmunity and Chronic Urticaria in Taiwan
Increase prevalence of thyroid autoimmunity is found in patients with chronic urticaria. About 5-34% of chronic urticaria patients is associated with the presence of thyroid autoimmunity who are euthyroid status whereas 5-10% of them with either hyperthyroidism or hypothyroidism.
Read the detailed description
There is no such report on the association of thyroid autoantibodies and chronic urticaria in Taiwan population yet. This study is designed to investigate the prevalence of thyroid autoimmunity associated with chronic urticaria in Taiwanese population. In addition, we intend to find out the change in the level of thyroid autoimmunity after the treatment in order to further understand their relationship. We also intend to find out the prognostic parameters in patients with the presence of thyroid autoimmunity and chronic urticaria.
- Conditions
- Skin Itching, Chronic Urticaria
- Being tested
- blood sampling
- Keywords
- urticaria, goiter
- Medical subject headings
- Pruritus, Chronic Urticaria, Urticaria, Goiter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBehavioural
blood sampling 10ml from the study subjects
| Study group | Role | What they receive |
|---|---|---|
| skin itching | Not described Receives: Behavioral: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of thyroid autoimmunity in chronic urticaria in Taiwan
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ItchingStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju-Ying Jiang, Far Eastern Memorial Hospital
- Investigators
- Jiang Ju Ying, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737451
- Sponsor's protocol ID
- 96051
- Status last verified
- Sep 2009
- First submitted
- 30 Jun 2008
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Thyroid Autoimmunity and Chronic Urticaria in Taiwan
- ClinicalTrials.gov ID
- NCT00737451
- Acronym / sponsor ID
- 96051
- Conditions
- Skin Itching, Chronic Urticaria
- Keywords
- urticaria, goiter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Aug 2008 (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.
Increase prevalence of thyroid autoimmunity is found in patients with chronic urticaria. About 5-34% of chronic urticaria patients is associated with the presence of thyroid autoimmunity who are euthyroid status whereas 5-10% of them with either hyperthyroidism or hypothyroidism.
Detailed description
There is no such report on the association of thyroid autoantibodies and chronic urticaria in Taiwan population yet. This study is designed to investigate the prevalence of thyroid autoimmunity associated with chronic urticaria in Taiwanese population. In addition, we intend to find out the change in the level of thyroid autoimmunity after the treatment in order to further understand their relationship. We also intend to find out the prognostic parameters in patients with the presence of thyroid autoimmunity and chronic urticaria.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| skin itching | – | Behavioral: blood sampling |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 and above with complaint of skin itching
Key inclusion criteria (2 listed)
- 18 years old and above
- skin itching for more than 6 months
Key exclusion criteria (1 listed)
- pure physical urticaria, infectious diseases, and food or food addictive hypersensitivity, chronic infection
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 |
|---|---|---|
| blood samplingblood sampling 10ml from the study subjects | Behavioural | skin itching |
Primary outcome
The prevalence of thyroid autoimmunity in chronic urticaria in Taiwan
Time frame: one year
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 27 Mar 2012.
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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.
Jiang Ju Ying, MD principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Itching and Chronic Urticaria, run by Far Eastern Memorial 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 2 inclusion and 1 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 27 Mar 2012. 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?
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?
The prevalence of thyroid autoimmunity in chronic urticaria in Taiwan (time frame: one year). 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 27 Mar 2012.