Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.

Peking Union Medical College Hospital180 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Rhinitis, Allergic, Perennial

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (1)

Peking Union Medical College Hospital traditional Chinese medicine department

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 0，4 and 8 weeks

Secondary Outcomes

Liver Function Examination

Liver function examination including alanine aminotransferase (ALT) (U/L) , aspartate transaminase (AST) (U/L) and glutamyl transpeptidase （GGT）(U/L).

Time frame: 0，4 and 8 weeks

Renal Function Examination

Renal function examination including blood urea nitrogen(BUN)（mmol/L）and urine creatinine(UCr) (mmol/d).

Time frame: 0，4 and 8 weeks

Secretory immunoglobulin E Examination

Time frame: 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).

Time frame: 0，4 and 8 weeks

Central Contacts

Xiaoyang Zhang, Doctor

CONTACT

(+86)13910769068 zhangxymz@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Urine Routine Examination

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

Time frame: 0，4 and 8 weeks

Fractional Exhaled Nitric Oxide Examination

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 8 weeks