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IRCT20110811007297N5 IRCT 2018-04-04 Shiraz University of Medical Sciences effect of simple zofa (hyssopus officinalis) syrup on persistant asthma : A randomized, tripple blind, controlled, clinical trial effect of simple zofa (hyssopus officinalis) syrup on persistant asthma 2017-10-23 anticipated 60 Complete https://irct.ir/trial/7747 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Qualified patients divide into tow groups of thirty. Only researcher can deciphers each battle according to early form of randomization, Blinding description: Paticipants,Care provider, Outcome assessor, Investigator and Data analyser wont know encoding. In this study, Care provider, Outcome assessor and Investigator are the same. Randomization and encoding will be done by pharmacist of Ahura company. Appearance of drug and placebo will be the same. They will be encode by two different digital code. Only researcher can deciphers each battle according to early form of randomization. 3 persistent asthma. Intervention 1: Intervention group: En Intervention group patients will consume oral intervention drug (hyssop syrup) twice a day( fasting and bed time with 6.5 gram hyssop in each time) for 4 weeks( consumption volume will determine after drug production). Patients will be advised to eat drug with warm water for prevention of constipation. Drug will be added to their common treatment. It means that according to EPR3 treatment protocol, at first line, long-acting beta-agonist (salmeterol) and inhaled steroid are prescribed to all patients( short-acting beta-agonist (salbutamol) is advised to all patients if necessary. Drug and placebo will produce by Ahura company. Drug component: floral branch of Hyssopus officinalis L . Place of plant purchase: Aramis grocery, Isfahan gate, in front of the Ali Ibn Abitaleb mosque, Dr. Ansarifard. Documentation of plant: Matching of bought plant with Hyssopus officinalis L. was done by Botanist School of Pharmacy, Shiraz and were maintained by PM984 code at her barium of that school. Drug production: Candy syrup will produce after Zufa extract by Ahura company. Placebo production: Candy syrup will produce by Ahura company too. GC-mass analysis of Zufa essence was done by phytochemistry group of Shiraz medical university. Identity was done according to Adamz book. Intervention 2: Control group: Control group patients will consume oral placebo (candy syrup) twice a day( as the same as Intervention group patients consumption). Patients will be advised to eat drug with warm water for prevention of constipation. Drug will be added to their common treatment. It means that according to EPR3 treatment protocol, at first line, long-acting beta-agonist (salmeterol) and inhaled steroid are prescribed to all patients( short-acting beta-agonist (salbutamol) is advised to all patients if necessary. Drug and placebo will produce by Ahura company. Yes - There is a plan to make this available What will be shared: outcome major information including: fev1/fvc pre and post study When: 6 months after results pressing To whom: scientific reaserchers Conditions: After publication of the extracted article of the clinical trial Where to obtain: su.azadeh.2005@gmail.com How to obtain: Sending the request via the email Comments:
public Dr Amir Mohammad Jaladat
Zand av. medical school
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3234 5145 drjaladat@gmail.com Shiraz University of Medical Sciences scientific Dr Leila Hoseini
Zand av. medical school
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3234 5145 leilahoseini@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) older than 18 years old patients confirm of disease by internist. diagnosis criteria: acording to NAEP EPR3 criteria for persistant asthma disease: FEV1: 60-80% 18 years no limit Both history of allergy to plant of mint family dissatisfaction of treatment in each stage side effect development through treatment theophylline cosumption diabetic patients convulsion history pregnant patients patienta that need to hospitalize Exacerbation at beginning of study smokers diability in statement of symptom intensity J45.0 Predominantly allergic asthma Treatment - Drugs Placebo Intervention group: En Intervention group patients will consume oral intervention drug (hyssop syrup) twice a day( fasting and bed time with 6.5 gram hyssop in each time) for 4 weeks( consumption volume will determine after drug production). Patients will be advised to eat drug with warm water for prevention of constipation. Drug will be added to their common treatment. It means that according to EPR3 treatment protocol, at first line, long-acting beta-agonist (salmeterol) and inhaled steroid are prescribed to all patients( short-acting beta-agonist (salbutamol) is advised to all patients if necessary. Drug and placebo will produce by Ahura company. Drug component: floral branch of Hyssopus officinalis L . Place of plant purchase: Aramis grocery, Isfahan gate, in front of the Ali Ibn Abitaleb mosque, Dr. Ansarifard. Documentation of plant: Matching of bought plant with Hyssopus officinalis L. was done by Botanist School of Pharmacy, Shiraz and were maintained by PM984 code at her barium of that school. Drug production: Candy syrup will produce after Zufa extract by Ahura company. Placebo production: Candy syrup will produce by Ahura company too. GC-mass analysis of Zufa essence was done by phytochemistry group of Shiraz medical university. Identity was done according to Adamz book. Control group: Control group patients will consume oral placebo (candy syrup) twice a day( as the same as Intervention group patients consumption). Patients will be advised to eat drug with warm water for prevention of constipation. Drug will be added to their common treatment. It means that according to EPR3 treatment protocol, at first line, long-acting beta-agonist (salmeterol) and inhaled steroid are prescribed to all patients( short-acting beta-agonist (salbutamol) is advised to all patients if necessary. Drug and placebo will produce by Ahura company Spirometry indicator: FEV1 and FEV1 /FVC. Timepoint: at the first of the study(before intervention) and 4 weeks after intervention. Method of measurement: spirometry set. Asthma treatment investigation score(The Expert Panel Report 3 (EPR 3)). Timepoint: at the first of the study(before intervention) and 4 weeks after intervention. Method of measurement: asthma treatment investigation questionnaire (The Expert Panel Report 3 (EPR 3)). Asthma control test(ACT) score. Timepoint: at the first of the study(before intervention) , 4 weeks and 8 week after intervention. Method of measurement: asthma control test questionnaire(ACT). Wheezing intensity determination. Timepoint: At the first of the study(before intervention) and 4 weeks after intervention. Method of measurement: History and physical exam with stethoscope. Lung dystemperament. Timepoint: At the first of the study(before intervention) and 4 weeks after intervention. Method of measurement: Primary questionnaire of lung dystemperament investigation in terms of warm and cold and primary questionnaire of lung dystemperament investigation in terms of wet and drought. Shiraz University of Medical Sciences Approved 2017-11-13 Ethics committee of Shiraz University of Medical school Zand street, Emam Hosein square, medical school, department number 2, 8th floor, ethic committee Shiraz Fars Iran (Islamic Republic of)