Rhinitis, AllergicNCT02486159
The Oligonucleotide Chip Analysis for Allergic Rhinitis Treatment in Herbal Plaster and Acupuncture
A study testing Herbal plaster (Sanfujiu) and Acupuncture in people with Rhinitis, Allergic, run by Chang Gung Memorial Hospital.
Trial summary
Using Oligonucleotide Chip Analysis, investigators compared gene expression levels in allergic rhinitis patients before and after a series of acupoint herbal plaster and Acupuncture treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Rhinitis, Allergic
- What is being tested?
- Herbal plaster (Sanfujiu) and Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Aug 2011
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Exhibited sneezing, runny nose, and congestion for more than 9 months of the year
- Did not take medication in the previous month
- Provided written consent to enter a Chang Gung Memorial Hospital Institutional Review Board (IRB)
Who cannot join
- Sinusitis
- Nasal polyps
- unwilling or unable to complete the full course of treatment
About this study
Using Oligonucleotide Chip Analysis, investigators compared gene expression levels in allergic rhinitis patients before and after a series of acupoint herbal plaster and Acupuncture treatment.
In the first year, Twenty-three participants with persistent allergic rhinitis each received four acupoint herbal plaster treatments, applied using the moxibustion technique, and clinical outcomes were evaluated using the Rhinitis Quality of Life Questionnaire (RQLQ). Peripheral blood samples were analyzed using an ImmunoCAP Phadiatop test, and patients were classified as phadiatop (Ph)-positive or -negative. Microarray results were examined for genes that were differentially expressed between (1) Ph-positive and -negative patients treated with herbal paste; and (2) before and after herbal paste treatment in the Ph-positive patient group.
In the second year, Twenty-seven participants with persistent allergic rhinitis each received four acupoint herbal plaster treatments and 8 courses of acupuncture treatment over 4 weeks in the same time.
Read the detailed description
This project「The oligonucleotide chip analysis for allergic rhinitis treatment in herbal plaster and acupuncture」 will be performed at Genomic Medicine Research Core Laboratory- GMRCL in Chung Gang Memorial Hospital. Allergic rhinitis patient will receive herbal plaster treatment in the first year, blood sample was attained before and after therapy. Then investigators use oligonucleotide chip to analyze the immunomodulatory effects of TCM in the treatment of allergic rhinitis. In the second year, the patient received herbal plaster and Acupuncture treatment in the same time.
Many allergic rhinitis patients accept TCM treatment here in Taiwan. According to recent journal reports, Traditional Chinese medicine performed in accordance with the principles of TCM would show significant immune-modulating effects, herbal plaster is an effective, safe and convenient treatment for allergic rhinitis. The mechanism of its efficacy needs further study. This project plan to combine the experience of clinical doctor and GMRCL Microarray for the mechanism of herbal plaster on allergic rhinitis.
Investigators study the effects of herbal plaster treatment for allergic rhinitis in the first year. And study the combine effect of herbal plaster and Acupuncture treatment in the second year. All patients during 18-45 years old were treated over a time period of 4 weeks. Patients' general well-being and several peripheral blood parameters were determined before and after the herbal plaster treatment. RNA was extracted from the blood and pooled into patient pool. Oligonucleotide chips were used to analysis the pooled RNA each year. The microarray analysis for the genomic change before and after the herbal plaster treatment or herbal plaster with Acupuncture treatment was studied .
- Conditions
- Rhinitis, Allergic
- Being tested
- Herbal plaster (Sanfujiu), Acupuncture
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal plaster (Sanfujiu)Drug
Also called Sanfujiu
The Acupoint herbal plaster consisted of mustard seed, fumarate, asarum, angelica, cinnamon, and ginger at a ratio of 3:3:2:2:0.5:4, respectively. The treatment was prepared by dissolving the ginger in water and adding the powder to form a plaster. Mixtures were formed into cakes of approximately 1.5 × 1.5 × 0.5 cm3 and were held in position using plastic sheets.
AcupunctureProcedure or surgery
Eight (8) acupuncture treatment sessions over 4 weeks were performed for each volunteer. The standard protocol for acupuncture treatment covered the most commonly treated acupoints for allergic rhinitis: LI4, ST36, LI20 in both sides, and EX-HN3. After insertion of needles at each acupoint, manual stimulation of needles on LI20 and EX-HN3 was repeated 3 times at 5-minute intervals. Electrostimulation was applied to the needles inserted in ST36 and LI4 with a frequency of 3-5 Hz, and the intensity was adjusted according to each volunteer's tolerance. All needles were removed 20 minutes later in each treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Herbal plaster and Acupuncture | Experimental | In the first year: Acupoint herbal plaster applications every one week over a 4-week period for a total of 4 applications.
In the second year: Acupoint herbal plaster used as the same method as first year, and combined with Acupuncture treatment in the same time. Receives: Drug: Herbal plaster (Sanfujiu); Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the third week
RQLQ, includes 28 questions in 7 categories. The RQLQ was designed to measure the impact of rhinitis on quality of life. It considers that allergic rhinitis patients often are troubled by nasal symptoms, eye symptoms, sleep problems, emotional problems, social issues, and other symptoms.
Measured: T0: before the first acupoint herbal plaster application, T3: the third week, 24 hours after the third acupoint herbal plaster application
Secondary outcomes (3)
Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the fourth week
RQLQ, includes 28 questions in 7 categories. The RQLQ was designed to measure the impact of rhinitis on quality of life. It considers that allergic rhinitis patients often are troubled by nasal symptoms, eye symptoms, sleep problems, emotional problems, social issues, and other symptoms.
Measured: T0: before the first acupoint herbal plaster application, T5: the fourth week, 24hours after the fourth acupoint herbal plaster applications
Compare gene expression levels before and after a series of acupoint herbal plaster and Acupuncture treatment
GeneChip Human Genome U133 Plus2 array (Affymetrix, Santa Clara, CA, USA) containing approximately 54,675 probes. Patient peripheral blood samples were obtained in 5-ml volumes at the following 6 times (T0-T5) during the study: (1) before (T0) and 24 h after the 1st (T1) acupoint herbal plaster application; (2)the third week, before (T2) and 24 h after the 3rd (T3) acupoint herbal plaster application; and (3) the fourth week, before the 4th (T4) and 24 h after the 4th (T5) acupoint herbal plaster application.
Measured: 6 times in four weeks
Detect serum allergen-specific IgE antibodies in patient
ImmunoCAP Phadiatop is a blood test widely used by ENT specialists in Taiwan to detect serum allergen-specific IgE antibodies. When patient provided written consent to enter the Chang Gung Memorial Hospital Institutional Review Board (IRB)-approved human trial, Patient diagnoses were confirmed by otolaryngologists. And the ImmunoCAP Phadiatop (InVitroSight, Phadia AB, Uppsala, Sweden) was performed.
Measured: When patient diagnoses were confirmed by otolaryngologists (baseline). Then the ImmunoCAP Phadiatop was performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hen-Hong Chang, M.D., PHD, Principal investigator, Department of Chinese Medicine, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486159
- Sponsor's protocol ID
- 98-0938B
- Status last verified
- Jun 2015
- First submitted
- 16 Jun 2015
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tai CJ, Chien LY. The treatment of allergies using Sanfujiu: A method of applying Chinese herbal medicine paste to acupoints on three peak summer days. Am J Chin Med. 2004;32(6):967-76. doi: 10.1142/S0192415X04002569.
PubMed 15673201Tai CJ, Chang CP, Huang CY, Chien LY. Efficacy of Sanfujiu to treat allergies: patient outcomes at 1 year after treatment. Evid Based Complement Alternat Med. 2007 Jun;4(2):241-6. doi: 10.1093/ecam/nel082. Epub 2006 Nov 24.
PubMed 17549242Juniper EF, Guyatt GH. Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis. Clin Exp Allergy. 1991 Jan;21(1):77-83. doi: 10.1111/j.1365-2222.1991.tb00807.x.
PubMed 2021881Benson M, Svensson PA, Carlsson B, Jernas M, Reinholdt J, Cardell LO, Carlsson L. DNA microarrays to study gene expression in allergic airways. Clin Exp Allergy. 2002 Feb;32(2):301-8. doi: 10.1046/j.1365-2222.2002.01300.x.
PubMed 11929497Shiue HS, Lee YS, Tsai CN, Hsueh YM, Sheu JR, Chang HH. Gene expression profile of patients with phadiatop-positive and -negative allergic rhinitis treated with acupuncture. J Altern Complement Med. 2010 Jan;16(1):59-68. doi: 10.1089/acm.2009.0024.
PubMed 20070140Petti FB, Liguori A, Ippoliti F. Study on cytokines IL-2, IL-6, IL-10 in patients of chronic allergic rhinitis treated with acupuncture. J Tradit Chin Med. 2002 Jun;22(2):104-11.
PubMed 12125480Shiue HS, Lee YS, Tsai CN, Chang HH. Treatment of allergic rhinitis with acupoint herbal plaster: an oligonucleotide chip analysis. BMC Complement Altern Med. 2016 Nov 4;16(1):436. doi: 10.1186/s12906-016-1418-0.
PubMed 27814709
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oligonucleotide Chip Analysis for Allergic Rhinitis Treatment in Herbal Plaster and Acupuncture
- ClinicalTrials.gov ID
- NCT02486159
- Acronym / sponsor ID
- 98-0938B
- Conditions
- Rhinitis, Allergic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 1 Jul 2015 (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.
Using Oligonucleotide Chip Analysis, investigators compared gene expression levels in allergic rhinitis patients before and after a series of acupoint herbal plaster and Acupuncture treatment.
In the first year, Twenty-three participants with persistent allergic rhinitis each received four acupoint herbal plaster treatments, applied using the moxibustion technique, and clinical outcomes were evaluated using the Rhinitis Quality of Life Questionnaire (RQLQ). Peripheral blood samples were analyzed using an ImmunoCAP Phadiatop test, and patients were classified as phadiatop (Ph)-positive or -negative. Microarray results were examined for genes that were differentially expressed between (1) Ph-positive and -negative patients treated with herbal paste; and (2) before and after herbal paste treatment in the Ph-positive patient group.
In the second year, Twenty-seven participants with persistent allergic rhinitis each received four acupoint herbal plaster treatments and 8 courses of acupuncture treatment over 4 weeks in the same time.
Detailed description
This project「The oligonucleotide chip analysis for allergic rhinitis treatment in herbal plaster and acupuncture」 will be performed at Genomic Medicine Research Core Laboratory- GMRCL in Chung Gang Memorial Hospital. Allergic rhinitis patient will receive herbal plaster treatment in the first year, blood sample was attained before and after therapy. Then investigators use oligonucleotide chip to analyze the immunomodulatory effects of TCM in the treatment of allergic rhinitis. In the second year, the patient received herbal plaster and Acupuncture treatment in the same time.
Many allergic rhinitis patients accept TCM treatment here in Taiwan. According to recent journal reports, Traditional Chinese medicine performed in accordance with the principles of TCM would show significant immune-modulating effects, herbal plaster is an effective, safe and convenient treatment for allergic rhinitis. The mechanism of its efficacy needs further study. This project plan to combine the experience of clinical doctor and GMRCL Microarray for the mechanism of herbal plaster on allergic rhinitis.
Investigators study the effects of herbal plaster treatment for allergic rhinitis in the first year. And study the combine effect of herbal plaster and Acupuncture treatment in the second year. All patients during 18-45 years old were treated over a time period of 4 weeks. Patients' general well-being and several peripheral blood parameters were determined before and after the herbal plaster treatment. RNA was extracted from the blood and pooled into patient pool. Oligonucleotide chips were used to analysis the pooled RNA each year. The microarray analysis for the genomic change before and after the herbal plaster treatment or herbal plaster with Acupuncture treatment was studied .
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Herbal plaster and Acupuncture | Experimental | Drug: Herbal plaster (Sanfujiu), Procedure: AcupunctureIn the first year: Acupoint herbal plaster applications every one week over a 4-week period for a total of 4 applications. In the second year: Acupoint herbal plaster used as the same method as first year, and combined with Acupuncture treatment in the same time. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Exhibited sneezing, runny nose, and congestion for more than 9 months of the year
- Did not take medication in the previous month
- Provided written consent to enter a Chang Gung Memorial Hospital Institutional Review Board (IRB)
Key exclusion criteria (3 listed)
- Sinusitis
- Nasal polyps
- unwilling or unable to complete the full course of treatment
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 |
|---|---|---|
| Herbal plaster (Sanfujiu)Also: SanfujiuThe Acupoint herbal plaster consisted of mustard seed, fumarate, asarum, angelica, cinnamon, and ginger at a ratio of 3:3:2:2:0.5:4, respectively. The treatment was prepared by dissolving the ginger in water and adding the powder to form a plaster. Mixtures were formed into cakes of approximately 1.5 × 1.5 × 0.5 cm3 and were held in position using plastic sheets. | Drug | Herbal plaster and Acupuncture |
| AcupunctureEight (8) acupuncture treatment sessions over 4 weeks were performed for each volunteer. The standard protocol for acupuncture treatment covered the most commonly treated acupoints for allergic rhinitis: LI4, ST36, LI20 in both sides, and EX-HN3. After insertion of needles at each acupoint, manual stimulation of needles on LI20 and EX-HN3 was repeated 3 times at 5-minute intervals. Electrostimulation was applied to the needles inserted in ST36 and LI4 with a frequency of 3-5 Hz, and the intensity was adjusted according to each volunteer's tolerance. All needles were removed 20 minutes later in each treatment session. | Procedure or surgery | Herbal plaster and Acupuncture |
Primary outcome
Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the third week
Time frame: T0: before the first acupoint herbal plaster application, T3: the third week, 24 hours after the third acupoint herbal plaster application
RQLQ, includes 28 questions in 7 categories. The RQLQ was designed to measure the impact of rhinitis on quality of life. It considers that allergic rhinitis patients often are troubled by nasal symptoms, eye symptoms, sleep problems, emotional problems, social issues, and other symptoms.
3 secondary outcomes
Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the fourth week
Time frame: T0: before the first acupoint herbal plaster application, T5: the fourth week, 24hours after the fourth acupoint herbal plaster applications
Compare gene expression levels before and after a series of acupoint herbal plaster and Acupuncture treatment
Time frame: 6 times in four weeks
Detect serum allergen-specific IgE antibodies in patient
Time frame: When patient diagnoses were confirmed by otolaryngologists (baseline). Then the ImmunoCAP Phadiatop was performed.
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 12 May 2017.
- Background: PubMed 15673201Tai CJ, Chien LY. The treatment of allergies using Sanfujiu: A method of applying Chinese herbal medicine paste to acupoints on three peak summer days. Am J Chin Med. 2004;32(6):967-76. doi: 10.1142/S0192415X04002569.
- Background: PubMed 17549242Tai CJ, Chang CP, Huang CY, Chien LY. Efficacy of Sanfujiu to treat allergies: patient outcomes at 1 year after treatment. Evid Based Complement Alternat Med. 2007 Jun;4(2):241-6. doi: 10.1093/ecam/nel082. Epub 2006 Nov 24.
- Background: PubMed 2021881Juniper EF, Guyatt GH. Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis. Clin Exp Allergy. 1991 Jan;21(1):77-83. doi: 10.1111/j.1365-2222.1991.tb00807.x.
- Background: PubMed 11929497Benson M, Svensson PA, Carlsson B, Jernas M, Reinholdt J, Cardell LO, Carlsson L. DNA microarrays to study gene expression in allergic airways. Clin Exp Allergy. 2002 Feb;32(2):301-8. doi: 10.1046/j.1365-2222.2002.01300.x.
- Background: PubMed 20070140Shiue HS, Lee YS, Tsai CN, Hsueh YM, Sheu JR, Chang HH. Gene expression profile of patients with phadiatop-positive and -negative allergic rhinitis treated with acupuncture. J Altern Complement Med. 2010 Jan;16(1):59-68. doi: 10.1089/acm.2009.0024.
- Background: PubMed 12125480Petti FB, Liguori A, Ippoliti F. Study on cytokines IL-2, IL-6, IL-10 in patients of chronic allergic rhinitis treated with acupuncture. J Tradit Chin Med. 2002 Jun;22(2):104-11.
- Derived from this study: PubMed 27814709Shiue HS, Lee YS, Tsai CN, Chang HH. Treatment of allergic rhinitis with acupoint herbal plaster: an oligonucleotide chip analysis. BMC Complement Altern Med. 2016 Nov 4;16(1):436. doi: 10.1186/s12906-016-1418-0.
- Individual participant dataSharing planned: No
Related trials for Rhinitis, Allergic
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
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.
Hen-Hong Chang, M.D., PHD principal investigator
Department of Chinese Medicine, Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Herbal plaster (Sanfujiu) and Acupuncture in people with Rhinitis, Allergic, run by Chang Gung Memorial Hospital.
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 3 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 12 May 2017. 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. 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?
Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the third week (time frame: T0: before the first acupoint herbal plaster application, T3: the third week, 24 hours after the third acupoint herbal plaster application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02486159, which also lists 7 linked publications.
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 12 May 2017.