Protocol summary
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Study aim
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Determine the effect of adding herbal compound based on Plantago major and almond gum on clinical symptoms and Pulmonary function tests in patients with resistant to treat Asthma
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Design
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In this study, 25 patients with resistant asthma who have inclusion criteria will be admitted to the Ghaem hospital and private clinics will be selected. It is a non-randomized, not-blind, nonplacebo-controlled, multicenter, Phase 2 clinical trial
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Settings and conduct
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The study is conducted in Ghaem hospital in Mashhad and private clinics and will not have blinding
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Participants/Inclusion and exclusion criteria
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Inclusion criteria is Resistant to treat Asthma in step 4 with A dry cough;
Exclusion criteria are patients with Unstable asthma, Upper respiratory tract infection, Gut Obstruction, Pregnancy and lactation and Concurrent use of other immunosuppressive drugs
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Intervention groups
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Intervention is treatment with a therapeutic package containing plantain seed and Almond gum.
Time of intervention is 4 weeks.
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Main outcome variables
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The study outcomes are reduction or improvement in Asthma symptoms regarding spirometry parameters, Asthma control test, and Asthma quality of life questionnaires.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016012026117N1
Registration date:
2017-01-31, 1395/11/12
Registration timing:
prospective
Last update:
2017-12-10, 1396/09/19
Update count:
1
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Registration date
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2017-01-31, 1395/11/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Mashhad University of Medical Sciences
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Expected recruitment start date
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2017-02-19, 1395/12/01
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Expected recruitment end date
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2017-06-22, 1396/04/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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ُStudy the effect of Plantago major and Almond gum on clinical symptoms and Pulmonary function tests in patients with resistant to treat Asthma
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Public title
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Effect of a herbal medicine combination in resistant to treat Asthma
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with resistant to treat asthma who had often dry cough in their history
Exclusion criteria:
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Age
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No age limit
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
25
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-06-11, 1395/03/22
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Ethics committee reference number
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IR.MUMS.REC.1395.181
Health conditions studied
1
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Description of health condition studied
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Asthma
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ICD-10 code
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J45.0
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ICD-10 code description
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Predominantly allergic asthma Allergic: bronchitis NOS rhinitis with asthma Atopic asthma Extrinsic allergic asthma Hay fever with asthma
Primary outcomes
1
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Description
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Asthma symptoms
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Timepoint
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Before and four weeks after intervention
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Method of measurement
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AQLQ and ACT Questionnaires
Secondary outcomes
1
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Description
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Airway obstruction
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Timepoint
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Before and 4 weeks after intervention
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Method of measurement
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Spirometry
Intervention groups
1
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Description
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Intervention group: Oral drug:Powder of almond gum and Plantago major seeds; Dose: 5 grams of the pack contains 3 grams of almond gum powder and 2 grams of Plantago major seed, every 8 hours, the duration of treatment (consumption): 4 weeks; How to use: Patients should dissolve the content of each pack in 150 ccs warm water and consume it after 30 minutes by maintaining an hour away from food.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Patients' information belongs to the project implementer and Mashhad University of Medical Sciences
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The clinical study report will be shared in the form of a paper
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When the data will become available and for how long
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The clinical study report will be available 6 months after the publication of the results
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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It is possible to use the results of the study for other research projects in collaboration with the execution research project and Mashhad University of Medical Sciences
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From where data/document is obtainable
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Applicants can contact the execution research project for this purpose
Email address: Anushiravanim@mums.ac.ir
Contact number 00989153218505
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What processes are involved for a request to access data/document
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The applicant can contact the execution research project 1 year after the publication of the results
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Comments
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