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IRCT20210913052453N2 IRCT 2022-06-21 Asadabad University of Medical Sciences Treatment of Upper Respiratory Infection Efficacy of Jinhua Qinggan Granules (JHQG) for the Treatment of Upper Respiratory Infection: A Clinical Trial 2022-06-22 anticipated 1000 Complete https://irct.ir/trial/63779 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The study will be conducted in 5 countries and each country includes a sample of 200 people, Randomization description: In this method we use random sequence generation using web randomization. Which is a type of Permuted block randomization. The output it gives us is an Excel file. And inside the Excel file, how each person enters which block is completely randomly determined. For example, if the block size is four, then the first four participants enrolled form the first block, and the next four form the next block, and so on. Randomization occurs within the blocks, so with blocks of size four there are six possible patterns: AABB, ABAB, ABBA, BAAB, BABA, and BBAA. Each block will randomize according to one of these six patterns, with the patterns chosen randomly and, generally, independently from block to block, Blinding description: The test drug should be coded according to the randomization list and the subject will be assigned to the group strictly according to the number of investigational drugs. After the final selection, subject number will be assigned to eligible 1000 subjects for identification i.e. 001, 002, …. 1000. All subjects will receive the corresponding treatment according to the distribution table (the trial drug, the control drug distributed according to the proportion of (3;1). The drug number will be kept same as the CRF number. 3 Condition 1: Acute nasopharyngitis. Condition 2: Acute sinusitis. Condition 3: Acute pharyngitis. Condition 4: Acute tonsillitis. Condition 5: Acute laryngitis and tracheitis. Condition 6: Acute obstructive laryngitis [croup] and epiglottitis. Condition 7: Acute upper respiratory infections of multiple and unspecified sites. Intervention 1: Intervention group: The treatment group will take Jinhua Qinggan granules. Jinhua Qinggan granules were invented during the H1N1 pandemic in 2009 (SFDA Approval number: Chinese medicine Z20160001); the prescription was designed by the Chinese and Western medical experts organized by the Beijing Administration of Traditional Chinese Medicine. Jinhua Qinggan granules doage: 5g/sachet; 1 sachet each time, 3 times daily aftermeal, dissolve in boil water. The course of treatment is 5 days, and the visit points are set on the 1st and 5th day, in which the 5th day is follow-up. Patients will be assessed by using 4-category ordinal scale and clinical signs and symptoms on 2nd, 3rd, 4th, and 5th day. All effectiveness and safety inspection items will be done once before the trial and once at follow-up point i.e. 5th day. In case of any new abnormality or abnormality aggravation after the treatment, should be followed up until normal or stable. Intervention 2: Control group: The Placebo control group shall receive JHQG Granules simulation (placebo) agent. The JHQG Placebo should be administered orally according to the recommended time and dose. Yes - There is a plan to make this available What will be shared: The purpose of this study is to publish the data in the form of an article that includes all the information including the results, working method, and consent form. When: Access started from 1402 To whom: Researchers working in academic and scientific institutions Conditions: If you use the method and results of this study, it is necessary to refer to this article and use it Where to obtain: Hemen moradi-sardareh How to obtain: We will contact them as soon as possible after the request Comments:
public Hemen Moradi-Sardareh
Assadabad city, Imam Khomeini Square, at the beginning of Rafsanjani street, the headquarters of the Faculty of Medical Sciences and Health Services of Assadabad
Assadabad Iran (Islamic Republic of) 6541843189 +98 81 3312 2499 hemen.moradi@yahoo.com Asadabad University of Medical Sciences scientific Ebrahim Nadi
Hamedan, Research Square, Shahid Fahmideh Street
Hamadan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۷۳۶ +98 81 3131 0000 nadi@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Body Temperature > 37.5ºC and highest point <39ºC within 24hours of enrollment, Within 12 hours of screening, three or more of the following main symptoms: Nasal Congestion, Rhinorrhea, Sore and/or scratchy throat, sneezing, headache, muscle or body aches, or malaise. The subject has signed the informed consent form. 18 years 65 years Both Other Respiratory diseases or acute and chronic nasal diseases or abnormal nasal mucosal function after nasal surgery or nasopharyngeal radiotherapy Severe primary health conditions associated with cardiovascular, cerebrovascular, pulmonary, hepatic, renal, endocrine and hematological diseases, hematopoietic system and mental illness or serious diseases affecting their survival, such as cancer or AIDS With severe cardiopulmonary dysfunction, cardiopulmonary insufficiency Subjects, who were treated with other Chinese and western drugs (including drugs for common cold, antiviral, antibiotics, and similar traditional Chinese medicine) and antipyretic and analgesic drugs within 6 hours before enrollment. Allergic individuals and those who are known to be allergic to experimental drugs. Pregnant women, and lactating women Subject, who has participated in the past 1 month in another clinical study. Subjects who are not suitable for the clinical trial based on investigators’ judgment. Subjects who consume alcohol. J00 J01 J02 J03 J04 J05 J06 Acute nasopharyngitis [common cold] Acute sinusitis Acute pharyngitis Acute tonsillitis Acute laryngitis and tracheitis Acute obstructive laryngitis [croup] and epiglottitis Acute upper respiratory infections of multiple and unspecified sites Treatment - Drugs Placebo Intervention group: The treatment group will take Jinhua Qinggan granules. Jinhua Qinggan granules were invented during the H1N1 pandemic in 2009 (SFDA Approval number: Chinese medicine Z20160001); the prescription was designed by the Chinese and Western medical experts organized by the Beijing Administration of Traditional Chinese Medicine. Jinhua Qinggan granules doage: 5g/sachet; 1 sachet each time, 3 times daily aftermeal, dissolve in boil water. The course of treatment is 5 days, and the visit points are set on the 1st and 5th day, in which the 5th day is follow-up. Patients will be assessed by using 4-category ordinal scale and clinical signs and symptoms on 2nd, 3rd, 4th, and 5th day. All effectiveness and safety inspection items will be done once before the trial and once at follow-up point i.e. 5th day. In case of any new abnormality or abnormality aggravation after the treatment, should be followed up until normal or stable Control group: The Placebo control group shall receive JHQG Granules simulation (placebo) agent. The JHQG Placebo should be administered orally according to the recommended time and dose. Curative Rate Evaluation. Timepoint: Measure the body temperature by treatment day 2/3/4/5. Method of measurement: In this study, data are obtained based on clinical and laboratory studies. Lab tests (Improvement in Lymphocyte count, CRP, ESR levels etc.). Timepoint: Measurements will be taken before and after the treatment period. Method of measurement: In this study, data are obtained based on clinical and laboratory studies. Recovery time: disappearance of all symptoms of more than 24 hours. Timepoint: Measurements are performed before and after treatment. Method of measurement: By questionnaire, clinical and laboratory. Defervescence rate (body temperature < 37 °C for more than 24 hours). Timepoint: Measurements are performed before, 2/3/4/5 after beginning of treatment, and after treatment. Method of measurement: By questionnaire, clinical and laboratory. Defervescence start time: (Time between treatment and body temperature decrease 0.5°C for more than 24h). Timepoint: Measurements are performed before and after treatment. Method of measurement: By questionnaire, clinical and laboratory. Recovery time of individual symptom. Timepoint: Measurements are performed before and after treatment. Method of measurement: By questionnaire, clinical and laboratory. Disappearance of individual symptom (symptom score reach 1 or 0 for more than 24 hours). Timepoint: Measurements are performed before and after treatment. Method of measurement: By questionnaire, clinical and laboratory. The quality of life of the product will be assessed by using the patient’s Quality of Life Assessment Questionnaire (QOL). Timepoint: Measurements are performed before and after treatment. Method of measurement: By questionnaire, clinical and laboratory. Ju Xie Chang (Beijing) Pharmaceutical Co. Ltd Asadabad University of Medical Sciences Ju Xie Chang (Beijing) Pharmaceutical Co. Ltd Approved 2022-05-25 research ethic committees of Asadabad school of medical sciences Hamadan Province, Assadabad County, Imam Khomeini Square, at the beginning of Rafsanjani St., the headquarters of the Faculty of Medical Sciences and Health Services of Assadabad Asadabad Hamadan Iran (Islamic Republic of)