]>
IRCT20170705034918N2 IRCT 2018-09-09 Shahre-kord University of Medical Sciences The effect of herbal inhalation of Hydroalcoholic Extract of lavender, Coriandrum sativum, Zataria multiflora, Mentha piperita, in treatment of Sinus Headache Clinical assessment of herbal inhalation of Hydroalcoholic Extract of lavender, Coriandrum sativum, Zataria multiflora, Mentha piperita, in treatment of Sinus Headache: A Randomized Double Blind Clinical Trial 2018-02-20 anticipated 64 Complete https://irct.ir/trial/26558 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified randomized collection will be done Based on age and gender; In such a way male and female patients will be assigned to the control and intervention group individually; and Randomization will be done by Random Allocation Software, Blinding description: Pharmaceutical and placebo products, with the same packaging, are categorized as A and B; And All phases of pharmaceutical formula and placebo preparation are carried out by a pharmacognosit co-worker. it should be noted that researcher and also patients will not be informed of the contents of any products. 2-3 Sinus Headache. Intervention 1: In the intervention group, every 8 hours, patients add 5 ml of the drug to 250 ml of boiling water and inhale the vapor of it for 15 minutes and the patients and researchers will not be aware of the contents of the drug and the placebo. The drug used in the intervention group contains a hydroalcoholic extracts of lavender, Coriandrum sativum, Zataria multiflora and Mentha piperita in a specified proportion according to the method mentioned in the British Pharmacopoeia, and the formulation will be prepared by the pharmacognostic colleagues. (Duration of the using drug is 14 days). Intervention 2: In the control group, patients will be given placebo every 8 hours, they add 5 ml of the placebo to 250 ml of boiling water and inhale the vapor of it for 15 minutes and Duration of the using placebo is 14 days. The placebo contains a Food coloring with no active ingredient and the same as the original medicine will be designed and packaged so the patients and researchers will not be aware of the contents of the the placebo. Yes - There is a plan to make this available What will be shared: Personal information of patients is confidential. When: The beginning of the data access period is after collecting and analyzing them until the paper is published. To whom: Executor of plan Conditions: In order to analyze and review the results of the study Where to obtain: Executor of plan How to obtain: The Information is not given to people who are not responsible for the research. Comments:
public Reza Heidari-soureshjani
Kashani Blvd.
Shahrekord Iran (Islamic Republic of) 8815894749 +98 38 3333 6539 heidari.reza1995@gmail.com Shahre-kord University of Medical Sciences scientific Dr Zahra Lorigooini
Kashani Blvd.
Shahrekord Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 38 3334 6692 gueini.z@skmu.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) People with a history of sinusitis assessed by the physician. People with no history of migraine headaches. People having at least three other symptoms of sinusitis such as nasal congestion. People with pain in one or more than one sinuses. no limit no limit Both People who have ulcer in their mouth and nose. People Having a history of allergy J32 Chronic sinusitis Treatment - Drugs Placebo In the intervention group, every 8 hours, patients add 5 ml of the drug to 250 ml of boiling water and inhale the vapor of it for 15 minutes and the patients and researchers will not be aware of the contents of the drug and the placebo. The drug used in the intervention group contains a hydroalcoholic extracts of lavender, Coriandrum sativum, Zataria multiflora and Mentha piperita in a specified proportion according to the method mentioned in the British Pharmacopoeia, and the formulation will be prepared by the pharmacognostic colleagues. (Duration of the using drug is 14 days) In the control group, patients will be given placebo every 8 hours, they add 5 ml of the placebo to 250 ml of boiling water and inhale the vapor of it for 15 minutes and Duration of the using placebo is 14 days. The placebo contains a Food coloring with no active ingredient and the same as the original medicine will be designed and packaged so the patients and researchers will not be aware of the contents of the the placebo. Headaches. Timepoint: Before and two weeks after the intervention. Method of measurement: Based on VAS criteria. Rhinorrhea. Timepoint: Before and two weeks after the intervention. Method of measurement: Self-reported. Nasal congestion. Timepoint: Before and two weeks after the intervention. Method of measurement: Self-reported. Dyspnea. Timepoint: Before and two weeks after the intervention. Method of measurement: Self-reported. Shahre-kord University of Medical Sciences Approved 2017-07-01 Ethics committee of shahrekord University of Medical Sciences Kashani Blvd, Shahrekord University of Medical Sciences Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)