Rhinitis, Allergic, PerennialNCT02653339
Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.
A study testing Qufeng Shengshi Fang and Loratadine and Loratadine in people with Rhinitis, Allergic, Perennial, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a controlled clinical trials about traditional Chinese medicine named Qufeng Shengshi Fang,which consisted of cicada slough,bombyx batryticatus,radix angelicae,radix sileris,honeysuckle flower,forsythia,lithospermum and radix glycyrrhizae,and Loratadine on treatment of Allergic Rhinitis.There are 180 Patients… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Qufeng Shengshi Fang and Loratadine and Loratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Aug 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet allergic rhinitis (include allergic rhinitis with asthma) diagnostic criteria at Peking Union Medical College Hospital Department of Allergy;
- have allergic rhinitis in episodes.
- without antihistamine,local anaesthetic or traditional Chinese medicine in last months.
- signed the informed consent form.
Who cannot join
- have severe deviation of nasal septum and nasal polyps.
- have nasal surgery or a history of cancer(tumor).
- have other serious illness or evidence of mental disorders.
- female in pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital traditional Chinese medicine department
Beijing, Beijing Municipality, 100730
Xiaoyang Zhang, Doctor, (+86)13910769068, zhangxymz@163.com
About this study
This is a controlled clinical trials about traditional Chinese medicine named Qufeng Shengshi Fang,which consisted of cicada slough,bombyx batryticatus,radix angelicae,radix sileris,honeysuckle flower,forsythia,lithospermum and radix glycyrrhizae,and Loratadine on treatment of Allergic Rhinitis.There are 180 Patients with allergic rhinitis recruited from Department of Allergy and Traditional Chinese.To carry on statistical analysis of the result of the self and between-group cross-reference by two questionnaires filled before and after treatment.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Qufeng Shengshi Fang and Loratadine, Loratadine
- Keywords
- traditional Chinese medicine, Loratadine, questionnaire survey
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qufeng Shengshi Fang and LoratadineDrug
The patients with allergic rhinitis are divided into two groups, one is experimental group, and the other is control group.
The experimental group patients are treated with Qufeng by oral, 200ml two times a day and Loratadine by oral,10mg QD
LoratadineDrug
Also called Claritin,WS1-(X-014)-2004Z
The patients with allergic rhinitis are divided into two groups, one is experimental group, and the other is control group.
The control group patients are treated with Loratadine by oral, 10mg QD
| Study group | Role | What they receive |
|---|---|---|
| Qufeng Shengshi Fang and Loratadine | Experimental | Qufeng Shengshi Fang is a traditional Chinese medicine form 8 kinds of herbs. Loratadine is the second generation antihistamines, after converted into its active metabolite Carrie period (carebastine), its antihistamines and allergy effect has been demonstrated in vitro and in vivo tests, also received data from clinical trials. Receives: Drug: Qufeng Shengshi Fang and Loratadine; Drug: Loratadine |
| Loratadine | Active comparator | Loratadine (INN) is a second-generation H1 histamine antagonist drug used to treat allergies. In structure, it is closely related to tricyclic antidepressants, such as imipramine, and is distantly related to the atypical antipsychotic quetiapine.Loratadine is marketed by Schering-Plough[needs update] under several trade names (e.g., Claritin) and also by Shionogi in Japan. It is available as a generic drug and is marketed for its nonsedating properties. In a version named Claritin-D or Clarinase, it is combined with pseudoephedrine, a decongestant; this makes it useful for colds, as well as allergies but adds potential side effects of insomnia, anxiety, and nervousness. Receives: Drug: Qufeng Shengshi Fang and Loratadine; Drug: Loratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement clinical symptoms of Allergen Rhinitis
Clinical symptoms of Allergen Rhinitis including Rhinocnesmus (0: No symptom;1:Intermittent;2:Formication but supportable;3:Formication and insupportable),Sneeze (0: No symptom;1:3-5 times everyday;2:6-10 times everyday;3:>11 times everyday),Rhinorrhea (0: No symptom;1:modicum;2:medium;3:mass),Rhinobyon (0: No symptom;1:Conscious inspiratory;2:Intermittent;3:Mostly breathing through mouth),Itchy eyes(0: No symptom;1:Pruritus but supportable;2:Need rub eyes occasionally;3:Need rub eyes frequently),Racryorrhea (0: No symptom;1:With sneezing;2:between 1and 3;3:No sneeze also ),Itchy ears and palate(0: No symptom;1:Intermittent;2:Pruritus but supportable;3:Pruritus and insupportable). Assessing the change by comparing the symptom score before and after treatment.
Measured: 0,4 and 8 weeks
Secondary outcomes (12)
Liver Function Examination
Liver function examination including alanine aminotransferase (ALT) (U/L) , aspartate transaminase (AST) (U/L) and glutamyl transpeptidase (GGT)(U/L).
Measured: 0,4 and 8 weeks
Renal Function Examination
Renal function examination including blood urea nitrogen(BUN)(mmol/L)and urine creatinine(UCr) (mmol/d).
Measured: 0,4 and 8 weeks
Secretory immunoglobulin E Examination
Measured: 0 and 8 weeks
Blood Routine Examination
Blood Routine Examination including white blood cell(WBC)(*10^9/L),monocyte number(MONO#)(*10^9/L),monocyte percentage (MONO%)(%),lymphocyte number(LY#)(*10^9/L),lymphocyte percentage (LY%)(%),neutrophil number(NEUT#)(*10^9/L),neutrophil percentage (NEUT%)(%),eosinophil number(NEUT#)(*10^9/L),eosinophil percentage (NEUT%)(%),red blood cell(RBC)(*10^12/L),hemoglobin(HGB) (g/L) and platelet count(PLT)(*10^9/L).
Measured: 0,4 and 8 weeks
Urine Routine Examination
Urine Routine Examination including occult blood(BLD)(Cells/μL) and proteinuria(PRO)(g/L).
Measured: 0,4 and 8 weeks
Fractional Exhaled Nitric Oxide Examination
Measured: 0 and 8 weeks
Test of Cytokine
Cytokines is a kind of low-molecular-weight soluble protein, which has function of regulating inherent immunity and adaptive immunity, erythropoiesis, cell growth and injured tissue repair and others.In the study FlowCellect™ Mouse Th2 Intracellular Cytokine Kit (FCIM025124) and Th17 Intracellular Cytokine Kit (FCIM025125) will be used to compare the change on cytokine before and after treatment. This FlowCellect Mouse Cytokine Th2 Identification Kit for flow cytometry is designed to enable a researcher a quick \& easy way to detect IL-4 expression in mouse Th2 CD4+ T-cells. This FlowCellect Mouse Cytokine Th17 Identification Kit for flow cytometry is designed to enable a researcher a quick \& easy way to detect IL-17 expression in mouse Th17 CD4+ T-cells.
Measured: 8 weeks
Test of Metabonomics
Metabolomics is the scientific study of chemical processes involving metabolites. Specifically, metabolomics is the "systematic study of the unique chemical fingerprints that specific cellular processes leave behind", the study of their small-molecule metabolite profiles. The metabolome represents the collection of all metabolites in a biological cell, tissue, organ or organism, which are the end products of cellular processes. Small molecules are the objects in Metabonomics which relative molecular mass is less than 1000.In the study NMR will be used as a way to assess the change on Metabonomics before and after treatment.
Measured: 8 weeks
Test of Proteomics
The proteome is the entire set of proteins expressed by a genome, cell, tissue or organism at a certain time. More specifically, it is the set of expressed proteins in a given type of cell or organism, at a given time, under defined conditions. The term is a portmanteau of proteins and genome. Proteomics is the study of the proteome.In the study Mass Spectrometry will be used to compare the change on proteome before and after treatment.
Measured: 8 weeks
Change of Exosomes
Exosomes as a utricle bubble structure are widely distributed in the peripheral blood, urine, saliva, ascites, amniotic fluid, and other body fluids. Exosomes carry different components, which are secreted by different cells, and these components give exosomes a variety in biological functions, such as potential biomarkers of immune cells, cancer, etc.In the study Ribo™ Exosome Isolation Reagent (for plasma or serum) will be used to compare the change on exosomes before and after treatment.
Measured: 8 weeks
IncRNA Sequencing
Long non-coding RNAs (lnc RNAs) are non-protein coding RNA molecules with the sequence longer than 200 nucleotides. They are four times amount as protein coding transcripts and play important roles in diverse cellular regulations. Function identification of these lncRNAs remains challenging although abundant efforts were put in this field. In the study gene expression profile , named RiboArrayTM lncDETECTTM Human Array, will be used which are provided by RiboBio Co., Ltd.
Measured: 8 weeks
Pulmonary function Examination
Pulmonary function Examination including forced expiratory volume in one second(FEV1)(L), forced vital capacity rate of one second(FEV1.0/FVC)(%), maximal mid-expiratory flow velocity(L/s), maximal expiratory flow in 50% vital capacity(L), maximal expiratory flow in 75% vital capacity(L) and peak expiratory flow rate(PEFR)(L/s).
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 Jan 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaochun Liang, Doctor, Study director, Peking Union Medical College Hospital traditional Chinese medicine department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653339
- Sponsor's protocol ID
- JS-958
- Status last verified
- Jan 2016
- First submitted
- 19 Dec 2015
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.
- ClinicalTrials.gov ID
- NCT02653339
- Acronym / sponsor ID
- JS-958
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- traditional Chinese medicine, Loratadine, questionnaire survey
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 12 Jan 2016 (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.
This is a controlled clinical trials about traditional Chinese medicine named Qufeng Shengshi Fang,which consisted of cicada slough,bombyx batryticatus,radix angelicae,radix sileris,honeysuckle flower,forsythia,lithospermum and radix glycyrrhizae,and Loratadine on treatment of Allergic Rhinitis.There are 180 Patients with allergic rhinitis recruited from Department of Allergy and Traditional Chinese.To carry on statistical analysis of the result of the self and between-group cross-reference by two questionnaires filled before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qufeng Shengshi Fang and Loratadine | Experimental | Drug: Qufeng Shengshi Fang and Loratadine, Drug: LoratadineQufeng Shengshi Fang is a traditional Chinese medicine form 8 kinds of herbs. Loratadine is the second generation antihistamines, after converted into its active metabolite Carrie period (carebastine), its antihistamines and allergy effect has been demonstrated in vitro and in vivo tests, also received data from clinical trials. |
| Loratadine | Active comparator | Drug: Qufeng Shengshi Fang and Loratadine, Drug: LoratadineLoratadine (INN) is a second-generation H1 histamine antagonist drug used to treat allergies. In structure, it is closely related to tricyclic antidepressants, such as imipramine, and is distantly related to the atypical antipsychotic quetiapine.Loratadine is marketed by Schering-Plough[needs update] under several trade names (e.g., Claritin) and also by Shionogi in Japan. It is available as a generic drug and is marketed for its nonsedating properties. In a version named Claritin-D or Clarinase, it is combined with pseudoephedrine, a decongestant; this makes it useful for colds, as well as allergies but adds potential side effects of insomnia, anxiety, and nervousness. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- meet allergic rhinitis (include allergic rhinitis with asthma) diagnostic criteria at Peking Union Medical College Hospital Department of Allergy;
- have allergic rhinitis in episodes.
- without antihistamine,local anaesthetic or traditional Chinese medicine in last months.
- signed the informed consent form.
Key exclusion criteria (4 listed)
- have severe deviation of nasal septum and nasal polyps.
- have nasal surgery or a history of cancer(tumor).
- have other serious illness or evidence of mental disorders.
- female in pregnancy and lactation
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 |
|---|---|---|
| Qufeng Shengshi Fang and LoratadineThe patients with allergic rhinitis are divided into two groups, one is experimental group, and the other is control group. The experimental group patients are treated with Qufeng by oral, 200ml two times a day and Loratadine by oral,10mg QD | Drug | Loratadine, Qufeng Shengshi Fang and Loratadine |
| LoratadineAlso: Claritin,WS1-(X-014)-2004ZThe patients with allergic rhinitis are divided into two groups, one is experimental group, and the other is control group. The control group patients are treated with Loratadine by oral, 10mg QD | Drug | Loratadine, Qufeng Shengshi Fang and Loratadine |
Primary outcome
Improvement clinical symptoms of Allergen Rhinitis
Time frame: 0,4 and 8 weeks
Clinical symptoms of Allergen Rhinitis including Rhinocnesmus (0: No symptom;1:Intermittent;2:Formication but supportable;3:Formication and insupportable),Sneeze (0: No symptom;1:3-5 times everyday;2:6-10 times everyday;3:>11 times everyday),Rhinorrhea (0: No symptom;1:modicum;2:medium;3:mass),Rhinobyon (0: No symptom;1:Conscious inspiratory;2:Intermittent;3:Mostly breathing through mouth),Itchy eyes(0: No symptom;1:Pruritus but supportable;2:Need rub eyes occasionally;3:Need rub eyes frequently),Racryorrhea (0: No symptom;1:With sneezing;2:between 1and 3;3:No sneeze also ),Itchy ears and palate(0: No symptom;1:Intermittent;2:Pruritus but supportable;3:Pruritus and insupportable). Assessing the change by comparing the symptom score before and after treatment.
12 secondary outcomes
Liver Function Examination
Time frame: 0,4 and 8 weeks
Renal Function Examination
Time frame: 0,4 and 8 weeks
Secretory immunoglobulin E Examination
Time frame: 0 and 8 weeks
Blood Routine Examination
Time frame: 0,4 and 8 weeks
Urine Routine Examination
Time frame: 0,4 and 8 weeks
Fractional Exhaled Nitric Oxide Examination
Time frame: 0 and 8 weeks
Test of Cytokine
Time frame: 8 weeks
Test of Metabonomics
Time frame: 8 weeks
Test of Proteomics
Time frame: 8 weeks
Change of Exosomes
Time frame: 8 weeks
IncRNA Sequencing
Time frame: 8 weeks
Pulmonary function Examination
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
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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.
Xiaochun Liang, Doctor study director
Peking Union Medical College Hospital traditional Chinese medicine department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qufeng Shengshi Fang and Loratadine and Loratadine in people with Rhinitis, Allergic, Perennial, run by Peking Union Medical College Hospital 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 4 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 22 Apr 2016. 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.
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 Xiaoyang Zhang, Doctor ((+86)13910769068, zhangxymz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement clinical symptoms of Allergen Rhinitis (time frame: 0,4 and 8 weeks). 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 22 Apr 2016.