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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Xiaoyang Zhang, Doctor contact

(+86)13910769068

zhangxymz@163.com

China1 site
  • Peking Union Medical College Hospital traditional Chinese medicine department

    Beijing, Beijing Municipality, 100730

    Xiaoyang Zhang, Doctor, (+86)13910769068, zhangxymz@163.com

Other trials in China

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.

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 groups in NCT02653339
Study groupRoleWhat they receive
Qufeng Shengshi Fang and LoratadineExperimentalQufeng 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
LoratadineActive comparatorLoratadine (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.

  1. 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)
  1. 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

  2. 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

  3. Secretory immunoglobulin E Examination

    Measured: 0 and 8 weeks

  4. 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

  5. Urine Routine Examination

    Urine Routine Examination including occult blood(BLD)(Cells/μL) and proteinuria(PRO)(g/L).

    Measured: 0,4 and 8 weeks

  6. Fractional Exhaled Nitric Oxide Examination

    Measured: 0 and 8 weeks

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted12 Jan 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionMar 2018 (estimated)
  4. Study completionAug 2018 (estimated)

Resources

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)
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

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.

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