Patch,Chinese HerbPhase 2NCT02580682
Sanfu Herbal Patch and Sanfu Moxibustion for Persistent Allergic Rhinitis: a Controlled Clinical Trial
A Phase 2 study testing Sanfu herbal patch, Sanfu moxibustion and Sanfu herbal patch and moxibustion in people with Patch,Chinese Herb and Moxibustion, run by Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust at 1 site in China.
Trial summary
To observe the efficacy of Sanfu herbal patch and Sanfu moxibustion on persistent allergic rhinitis,and comparing the differences between the combination of these 2 methods with each method alone. Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Patch,Chinese Herb, Moxibustion, Allergic Rhinitis
- What is being tested?
- Sanfu herbal patch, Sanfu moxibustion and Sanfu herbal patch and moxibustion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Dec 2020
- 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 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients recruited to this study must meet the following inclusion criteria:
- Males or females aged between 5 and 60 years.
- Each PAR patient must be diagnosed by an otolaryngologist using the following diagnostic criteria: major symptoms of paroxysm rhinocnesmus, continuous sneezing, nasal obstruction, and significant quantities of clear and thin nasal mucus, accompanied by symptoms of hyposmia and itching of the eyes and throat. These symptoms should last for or add up to 1 hour a day. The attacks should occur for more than 4 weeks and at last for at least 4 days each week.
- One of 2 laboratory results is positive: skin prick test or serum high circulating levels of allergen-specific IgE antibody detected by a specific blood test for allergy called a radioallergosorbent (RAST) test
- The course of the disease is more than 1 year.
- Voluntary signing of an informed consent form.
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- No current participation in any other clinical trials. Exclusion criteria
- Patients with any of the following conditions will be excluded:
- Allergies to the herbal medicines, a moxa smoke or adhesive tape applied in this study, and the skin at the specific acupoint has physical scars or breakage.
- Patients with other allergic diseases, such as allergic asthma.
- Patients who received acupuncture and moxibustion treatment, Chinese herbal medicine, nasal inhalation of herbal medicine, physical therapy or other external treatment for AR within the last 4 weeks
- Patients who received immune therapy or systematic hormonotherapy in the past 1 year.
- Pregnant women, lactating women, or women preparing for pregnancy in 2 years.
- Patients with serious medical disorders such as congenital heart disease, severe nephropathy, mental diseases, and infectious diseases including tuberculosis, hepatitis, and AIDS.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hubei university of TCM
Wuhan, Hubei, 430000
Fengxia Liang, Doctor, +86 18971371818, 315938821@qq.com
About this study
Official title: San-fu Herbal Patch and San-fu Moxibustion for Persistent Allergic Rhinitis: a Randomized Controlled Clinical Trial
To observe the efficacy of Sanfu herbal patch and Sanfu moxibustion on persistent allergic rhinitis,and comparing the differences between the combination of these 2 methods with each method alone.
- Conditions
- Patch,Chinese Herb, Moxibustion, Allergic Rhinitis
- Being tested
- Sanfu herbal patch, Sanfu moxibustion, Sanfu herbal patch and moxibustion
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sanfu herbal patchDrug
The formula of the patch consists of Huang Qi (Astagalus Membranaceus), Fu Zi (Aconiti Lateralis Radix Praeparata), Yan Hu Suo (Rhizoma Corydalis), Xi Xin (Herba As5ari), Bai Jie Zi (Semen Sinapis Albae) and Rou Gui(Cortex Cinnamomi), in a proportion of 2:2:1:1:2:1.
Sanfu moxibustionDrug
Moxibustion is a kind of thermal therapy without any feeling of pain or swell.Moxibustion exerts its therapeutic effect by thermal power and the application of moxa.
Sanfu herbal patch and moxibustionDrug
use Sanfu moxibustion followed by Sanfu herbal patch
| Study group | Role | What they receive |
|---|---|---|
| Sanfu herbal patch | Experimental | one kind of acupoint application which used in hot dog days of summer,The formula of the patch consists of Huang Qi (Astagalus Membranaceus), Fu Zi (Aconiti Lateralis Radix Praeparata), Yan Hu Suo (Rhizoma Corydalis), Xi Xin (Herba asarum), Bai Jie Zi (Semen Sinapis Albae), and Rou Gui (Cortex Cinnamomi) at a ratio of 2:2:1:1:2:1.The bilateral Feishu (BL13), Pishu (BL20), Shenshu (BL23), Neiguan (PC6), and Guanyuan (CV4) acupoints were selected for treatment Receives: Drug: Sanfu herbal patch |
| Sanfu moxibustion | Experimental | use moxibustion in hot dog days of summer,and adopting the indirect moxibustion box method at the bilateral BL13, BL20, and BL23 acupoints Receives: Drug: Sanfu moxibustion |
| Sanfu herbal patch and Sanfu moxibustion | Experimental | use herbal patch and moxibustion together in hot dog days Receives: Drug: Sanfu herbal patch and moxibustion |
| controlled | No intervention | patients in this group will not accept herbal patch or moxibustion therapy in these 3 years. After the 3-year experimental period they will be offered corresponding treatments for free as well, so they are in our wait list. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score(TNSS)
In TNSS, symptoms of nasal congestion , sneezing, nasal itching and rhinorrhea are assessed by scores ranging from 0 to 3. A score of 0 indicates no symptoms, 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity .TNSS is calculated by adding the score for each symptom together
Measured: three years
Secondary outcomes (3)
visual analogue scale (VAS)
VAS is a 10cm scale to assess the impact of AR on life quality ranging from score of 0 to 10, which stands for "no impact" to "serious impact
Measured: three years
Rhinitis Quality of Life Questionnaire (RQLQ)
The RQLQ contains 28 questions to evaluate impairment of everyday life caused by symptoms of nose and eyes. Seven dimensions will be assessed, including daily life, sleep, non-nosal/optical symptoms, practical problems, nosal symptoms, optical symptoms and emotion. Every question should be answered by scores: 0 - not trouble, 1 - any trouble at all, 2 - somewhat troubled, 3 - moderately troubled, 4 - quite a bit of trouble, 5 - very troubled, 6 - extremely troubled.
Measured: three years
36-item Short-Form Health Survey (SF-36)
SF-36 consists of 36 items categorized as eight dimensions: social functioning (two items), role limitation-emotion (three items), mental health (five items), physical functioning (ten items), role limitation-physical (four items), bodily pain (two items), vitality (four items), general health (five items) and one question of health change in recent one year.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startJul 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patch,Chinese HerbStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580682
- Sponsor's protocol ID
- XTCX2014-SFT
- Status last verified
- Apr 2017
- First submitted
- 18 Oct 2015
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: we have recruited approximately sixty patients in tha last year, informations including contacting numbers, medical history, questionnaires and follow-up materials, we have not decided in which way we could share these data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- San-fu Herbal Patch and San-fu Moxibustion for Persistent Allergic Rhinitis: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02580682
- Acronym / sponsor ID
- XTCX2014-SFT
- Conditions
- Patch,Chinese Herb, Moxibustion, Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and MoxibustUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Oct 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.
To observe the efficacy of Sanfu herbal patch and Sanfu moxibustion on persistent allergic rhinitis,and comparing the differences between the combination of these 2 methods with each method alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sanfu herbal patch | Experimental | Drug: Sanfu herbal patchone kind of acupoint application which used in hot dog days of summer,The formula of the patch consists of Huang Qi (Astagalus Membranaceus), Fu Zi (Aconiti Lateralis Radix Praeparata), Yan Hu Suo (Rhizoma Corydalis), Xi Xin (Herba asarum), Bai Jie Zi (Semen Sinapis Albae), and Rou Gui (Cortex Cinnamomi) at a ratio of 2:2:1:1:2:1.The bilateral Feishu (BL13), Pishu (BL20), Shenshu (BL23), Neiguan (PC6), and Guanyuan (CV4) acupoints were selected for treatment |
| Sanfu moxibustion | Experimental | Drug: Sanfu moxibustionuse moxibustion in hot dog days of summer,and adopting the indirect moxibustion box method at the bilateral BL13, BL20, and BL23 acupoints |
| Sanfu herbal patch and Sanfu moxibustion | Experimental | Drug: Sanfu herbal patch and moxibustionuse herbal patch and moxibustion together in hot dog days |
| controlled | No intervention | –patients in this group will not accept herbal patch or moxibustion therapy in these 3 years. After the 3-year experimental period they will be offered corresponding treatments for free as well, so they are in our wait list. |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Males or females aged between 5 and 60 years.
- Each PAR patient must be diagnosed by an otolaryngologist using the following diagnostic criteria: major symptoms of paroxysm rhinocnesmus, continuous sneezing, nasal obstruction, and significant quantities of clear and thin nasal mucus, accompanied by symptoms of hyposmia and itching of the eyes and throat. These symptoms should last for or add up to 1 hour a day. The attacks should occur for more than 4 weeks and at last for at least 4 days each week.
- One of 2 laboratory results is positive: skin prick test or serum high circulating levels of allergen-specific IgE antibody detected by a specific blood test for allergy called a radioallergosorbent (RAST) test
- The course of the disease is more than 1 year.
- Voluntary signing of an informed consent form.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Sanfu herbal patchThe formula of the patch consists of Huang Qi (Astagalus Membranaceus), Fu Zi (Aconiti Lateralis Radix Praeparata), Yan Hu Suo (Rhizoma Corydalis), Xi Xin (Herba As5ari), Bai Jie Zi (Semen Sinapis Albae) and Rou Gui(Cortex Cinnamomi), in a proportion of 2:2:1:1:2:1. | Drug | Sanfu herbal patch |
| Sanfu moxibustionMoxibustion is a kind of thermal therapy without any feeling of pain or swell.Moxibustion exerts its therapeutic effect by thermal power and the application of moxa. | Drug | Sanfu moxibustion |
| Sanfu herbal patch and moxibustionuse Sanfu moxibustion followed by Sanfu herbal patch | Drug | Sanfu herbal patch and Sanfu moxibustion |
Primary outcome
Total Nasal Symptom Score(TNSS)
Time frame: three years
In TNSS, symptoms of nasal congestion , sneezing, nasal itching and rhinorrhea are assessed by scores ranging from 0 to 3. A score of 0 indicates no symptoms, 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity .TNSS is calculated by adding the score for each symptom together
3 secondary outcomes
visual analogue scale (VAS)
Time frame: three years
Rhinitis Quality of Life Questionnaire (RQLQ)
Time frame: three years
36-item Short-Form Health Survey (SF-36)
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Individual participant dataSharing planned: Undecided. we have recruited approximately sixty patients in tha last year, informations including contacting numbers, medical history, questionnaires and follow-up materials, we have not decided in which way we could share these data.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sanfu herbal patch, Sanfu moxibustion and Sanfu herbal patch and moxibustion in people with Patch,Chinese Herb and Moxibustion, run by Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust 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 14 inclusion and 0 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 26 Mar 2018. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fengxia Liang, Doctor (+86 18971371818, 315938821@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Nasal Symptom Score(TNSS) (time frame: three years). 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 26 Mar 2018.