: A randomized, tripple blind, controlled, clinical trial effect of simple zofa (hyssopus officinalis) syrup on persistant asthma

effect of simple hyssop syrup on asthmatic patients

In this research, 60 asthmatic eligible patients were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.

Patients known by plan notifications (playing in the Shiraz government and nongovernment care centers) will come to Hakim Emaddin Shirazi clinic. They will visit by an internist and persistant asthmatic patients will be referd to traditional medicine resident. Eligible patients refer to spirometry part of shahid faghihi hospital after informed consent signing. Then they refer to Hakim Emaddin Shirazi clinic for receiving drug, primary outcome measures registration(spirometry indicator: FEV1 , FEV1 /FVC , EPR3 asthma treatment investigation score(7th index), ACT score(6th index)). Researcher calls all the patients in second week to prevent missing and ask them about drug consumption and probably side effects. patients will be visited after 4 weeks in Hakim Emaddin Shirazi clinic and will be refered to shahid faghihi hospital for final spirometry. Then they refer to Hakim Emaddin Shirazi clinic for secondary outcome measures registration(FEV1 , FEV1 /FVC , EPR3 asthma treatment investigation score(7th index), ACT score(6th index)). Completing ethic form(8th index), demographic information form(first index), lung nature form(3th and 4th index), receiving drug consumption checklist(5th index) and recording of wheezing intensity will be done at the first visit. Completing lung nature form and recording of wheezing intensity will be done at the second visit too. Wheezing intensity definition( according to history and physical exam): sever: difficult breathing at rest, expiration wheezing and generalized rhonchi(1 score), moderate: non difficult breathing at rest, expiration wheezing and generalized rhonchi(2 score), mild: prolonged expiration,scattered rhonchi(3 score). ACT form will be completed after 8 weeks too via calling.Returning to clinic will be advised to all patients if symptom get worst or side effect appear. 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). 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. if side effect happen, drug will be interrupted and necessary cares will be done. Participants,care provider, outcome assessor, investigator and data analyzer will be blind. 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.

Inclusion criteria: older than 18 years old patients, confirm of disease by internist. diagnosis criteria: according to NAEP EPR3 criteria for persistent asthma disease: FEV1: 60-80%; Exclusion criteria: 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, patient that need to hospitalize, exacerbation at beginning of study, smokers, disability in statement of symptom intensity

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). 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.

spirometry indicator: FEV1 , FEV1 /FVC ; EPR3 asthma treatment investigation score(7th index); ACT score(6th index).

Qualified patients divide into tow groups of thirty. Only researcher can deciphers each battle according to early form of randomization.

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.

outcome major information including: fev1/fvc pre and post study

6 months after results pressing

scientific reaserchers

After publication of the extracted article of the clinical trial

su.azadeh.2005@gmail.com

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