Allergic Rhinitis (AR)NCT02470845
Trial of Tian Jiu Therapy for Allergic Rhinitis
A study testing herbal patches of Tian Jiu group in people with Allergic Rhinitis (AR), run by Hong Kong Baptist University at 1 site in China.
Trial summary
The aim of this study is to investigate the efficacy and safety of Tian Jiu in the treatment of allergic rhinitis compared with placebo and waitlist patients in Hong Kong. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Allergic Rhinitis (AR)
- What is being tested?
- herbal patches of Tian Jiu group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Sep 2016
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Positive skin prick tests
- High circulating levels of allergen-specific IgE antibody detected by a specific blood test for allergy called radioallergosorbent test (RAST)]
- Clinical history or allergen to have been identified
- Nasal provocation (test)
Who cannot join
- Allergic asthma, moderate to severe atopic dermatitis, autoimmune disorders, severe chronic inflammatory diseases, history of anaphylactic reactions, hypersensitivity to cetirizine or related drugs, specific immunotherapy during the past 3 years or planned in the next 2 years, pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Tian Jiu Therapy for Allergic Rhinitis
The aim of this study is to investigate the efficacy and safety of Tian Jiu in the treatment of allergic rhinitis compared with placebo and waitlist patients in Hong Kong.
Read the detailed description
This will be a prospective, randomized, single-blinded, controlled trial in patients with AR. After a one-week run-in period, eligible subjects will be randomly assigned to the Tian Jiu group, placebo-control group and waitlist-control group. The TJ and placebo-control groups will undergo a 4-week treatment with one session per week and one 4-week post-treatment follow-up. Participants in the waitlist-control group will not receive any treatment during the first 4 weeks but will be required to be assessed. The total study period will be nine weeks.
- Conditions
- Allergic Rhinitis (AR)
- Being tested
- herbal patches of Tian Jiu group, placebo patches of placebo-control group
- 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 patches of Tian Jiu groupDrug
The formula of herbal patch consists of BaiJieZi (Sinapis Semen), Yan Hu Suo（CorydulisRhizoma）、ZhiGan Sui (Kansui Radix)、Xi Xin (Asari Radix et rhizama) and Rengong She xiang(Moschus Artifactus) . The four herbs will be ground into powder, mixed thoroughlywith 20% BaiJieZi (Sinapis Semen), 25% Yan Hu Suo（CorydulisRhizoma), 15% ZhiGan Sui (Kansui Radix), and 40% Xi Xin (Asari Radix et rhizama), and the mixed powder will mix with fresh ginger juice in the ratio of 20g to 25 ml. The mixture will be made to a patch weighted as 2g and 1cm*1cm round size. 0.02g artificial She Xiang (Moschus Artifactus) will be added on top of each patch. Each patch will be applied on one acupoint.
placebo patches of placebo-control groupDrug
The placebo patch consists of flour and edible pigments. These two ingredients will be mixed with water and made to patches weighted as 2g and 1cm*1cm round size.Each patch will be applied on one acupoint.
| Study group | Role | What they receive |
|---|---|---|
| Tian Jiu group | Experimental | The TJ group will undergo a 4-week treatment with herbal patches one session per week and a 4-week post-treatment follow-up, of one assessment session per week. Participants in the TJ group will be treated with herbal patches of Tian Jiu group on five acupoints on the back. Receives: Drug: herbal patches of Tian Jiu group |
| Placebo-control group | Sham comparator | The placebo-control group will undergo a 4-week treatment with placebo patches one session per week and a 4-week post-treatment follow-up, of one assessment session per week. Participants in this group will be treated with placebo patches of placebo-control group on the same acupionts as the TJ group. Receives: Drug: placebo patches of placebo-control group |
| Waitlist-control group | No intervention | The waitlist-control group will receive no treatment during the first 4 weeks but, beginning with the 5th week this group will receive TJ treatment for four weeks as compensatory. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of total nasal symptom score
The change in the weekly average of total nasal symptom score (TNSS) recorded in participants' diaries from baseline（ Week 0） to end of the treatment（ Week 4）and post-treatment follow-up ( Week 8)
Measured: 4 weeks
Secondary outcomes (2)
Change of the Rhinitis Quality of Life Questionnaire (RQLQ)
The change in symptoms will be measured using the Rhinitis Quality of Life Questionnaire (RQLQ), by comparing the baseline( Week 0) with the scores within treatment (Week 2, 3), end of treatment( Week 4) and post-treatment follow-up ( Week 8).
Measured: 8 weeks
Change in need for medication
The change in need for medication will be measured using an RM score (RMS), by comparing the baseline (Week 0) with the scores within treatment (Week 2, 3), end of treatment( Week 4) and post-treatment follow-up ( Week 8).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJul 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic Rhinitis (AR)Studies 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
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhaoXiang Bian, Hong Kong Baptist University
- Investigators
- Zhao Xiang Bian, Ph.D., M. D., Principal investigator, School of Chinese Medicine, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470845
- Sponsor's protocol ID
- TJAR001
- Status last verified
- Mar 2017
- First submitted
- 17 May 2015
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kun W, Zhong LL, Dai L, Cheng CW, Lu AP, Bian ZX. Tian Jiu therapy for allergic rhinitis: study protocol for a randomized controlled trial. Trials. 2016 May 17;17(1):248. doi: 10.1186/s13063-016-1374-5.
PubMed 27189087
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Tian Jiu Therapy for Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02470845
- Acronym / sponsor ID
- TJAR001
- Conditions
- Allergic Rhinitis (AR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Jun 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.
The aim of this study is to investigate the efficacy and safety of Tian Jiu in the treatment of allergic rhinitis compared with placebo and waitlist patients in Hong Kong.
Detailed description
This will be a prospective, randomized, single-blinded, controlled trial in patients with AR. After a one-week run-in period, eligible subjects will be randomly assigned to the Tian Jiu group, placebo-control group and waitlist-control group. The TJ and placebo-control groups will undergo a 4-week treatment with one session per week and one 4-week post-treatment follow-up. Participants in the waitlist-control group will not receive any treatment during the first 4 weeks but will be required to be assessed. The total study period will be nine weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tian Jiu group | Experimental | Drug: herbal patches of Tian Jiu groupThe TJ group will undergo a 4-week treatment with herbal patches one session per week and a 4-week post-treatment follow-up, of one assessment session per week. Participants in the TJ group will be treated with herbal patches of Tian Jiu group on five acupoints on the back. |
| Placebo-control group | Sham comparator | Drug: placebo patches of placebo-control groupThe placebo-control group will undergo a 4-week treatment with placebo patches one session per week and a 4-week post-treatment follow-up, of one assessment session per week. Participants in this group will be treated with placebo patches of placebo-control group on the same acupionts as the TJ group. |
| Waitlist-control group | No intervention | –The waitlist-control group will receive no treatment during the first 4 weeks but, beginning with the 5th week this group will receive TJ treatment for four weeks as compensatory. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Positive skin prick tests
- High circulating levels of allergen-specific IgE antibody detected by a specific blood test for allergy called radioallergosorbent test (RAST)]
- Clinical history or allergen to have been identified
- Nasal provocation (test)
Key exclusion criteria (1 listed)
- Allergic asthma, moderate to severe atopic dermatitis, autoimmune disorders, severe chronic inflammatory diseases, history of anaphylactic reactions, hypersensitivity to cetirizine or related drugs, specific immunotherapy during the past 3 years or planned in the next 2 years, pregnancy or breastfeeding.
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 patches of Tian Jiu groupThe formula of herbal patch consists of BaiJieZi (Sinapis Semen), Yan Hu Suo（CorydulisRhizoma）、ZhiGan Sui (Kansui Radix)、Xi Xin (Asari Radix et rhizama) and Rengong She xiang(Moschus Artifactus) . The four herbs will be ground into powder, mixed thoroughlywith 20% BaiJieZi (Sinapis Semen), 25% Yan Hu Suo（CorydulisRhizoma), 15% ZhiGan Sui (Kansui Radix), and 40% Xi Xin (Asari Radix et rhizama), and the mixed powder will mix with fresh ginger juice in the ratio of 20g to 25 ml. The mixture will be made to a patch weighted as 2g and 1cm*1cm round size. 0.02g artificial She Xiang (Moschus Artifactus) will be added on top of each patch. Each patch will be applied on one acupoint. | Drug | Tian Jiu group |
| placebo patches of placebo-control groupThe placebo patch consists of flour and edible pigments. These two ingredients will be mixed with water and made to patches weighted as 2g and 1cm*1cm round size.Each patch will be applied on one acupoint. | Drug | Placebo-control group |
Primary outcome
Change of total nasal symptom score
Time frame: 4 weeks
The change in the weekly average of total nasal symptom score (TNSS) recorded in participants' diaries from baseline（ Week 0） to end of the treatment（ Week 4）and post-treatment follow-up ( Week 8)
2 secondary outcomes
Change of the Rhinitis Quality of Life Questionnaire (RQLQ)
Time frame: 8 weeks
Change in need for medication
Time frame: 8 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 15 Mar 2017.
- Derived from this study: PubMed 27189087Kun W, Zhong LL, Dai L, Cheng CW, Lu AP, Bian ZX. Tian Jiu therapy for allergic rhinitis: study protocol for a randomized controlled trial. Trials. 2016 May 17;17(1):248. doi: 10.1186/s13063-016-1374-5.
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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.
Zhao Xiang Bian, Ph.D., M. D. principal investigator
School of Chinese Medicine, Hong Kong Baptist 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 herbal patches of Tian Jiu group in people with Allergic Rhinitis (AR), run by Hong Kong Baptist University at 1 site in China.
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 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 15 Mar 2017. 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 China. 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?
Change of total nasal symptom score (time frame: 4 weeks). 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 NCT02470845, which also lists 1 linked publication.
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 15 Mar 2017.