Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.

Rhinitis, Allergic, Perennial Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02653339
• Other study ID #: JS-958
• Status: Not yet recruiting
• Phase: N/A
• First received: December 19, 2015
• Last updated: January 8, 2016
• Start date: February 2016
• Est. completion date: August 2018

Study information

• Verified date: January 2016
• Source: Peking Union Medical College Hospital
• Contact: Xiaoyang Zhang, Doctor
• Phone: (+86)13910769068
• Email: zhangxymz[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical 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 Ebastine 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: August 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Qufeng Shengshi Fang and Ebastine
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 ebastine by oral,10mg QD
• Ebastine
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 ebastine by oral, 10mg QD

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital traditional Chinese medicine department	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks	No
Secondary	Liver Function Examination	Liver function examination including alanine aminotransferase (ALT) (U/L) , aspartate transaminase (AST) (U/L) and glutamyl transpeptidase (GGT)(U/L).	4 weeks	Yes
Secondary	Renal Function Examination	Renal function examination including blood urea nitrogen(BUN)(mmol/L)and urine creatinine(UCr) (mmol/d).	4 weeks	Yes
Secondary	Secretory immunoglobulin E Examination		4 weeks	No
Secondary	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).	4 weeks	Yes
Secondary	Urine Routine Examination	Urine Routine Examination including occult blood(BLD)(Cells/µL) and proteinuria(PRO)(g/L).	4 weeks	Yes
Secondary	Fractional Exhaled Nitric Oxide Examination		4 weeks	No
Secondary	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.	8 weeks	No
Secondary	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.	8 weeks	No
Secondary	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.	8 weeks	No
Secondary	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.	8 weeks	No
Secondary	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.	8 weeks	No
Secondary	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).	4 weeks	No