Protocol summary
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Study aim
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Investigation of the effect of " Prunus Dulcis Linctus" on the Asthmatic Patients (refractory with Chronic Cough)
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Design
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A clinical trial with a control group, single_blind, non_random, phase 3 on 100 patients.
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Settings and conduct
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Patients selected from the breathing laboratory of Imam Reza hospital of Tabriz University of Medical Sciences, Iran in 2021. In this study, 100 Subjects were divided into two groups; one group was treated with Prunus Dulcis Linctus for 14 Days and another group took the only placebo (participants were not informed whether they receive the intervention drug or placebo).
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age (>14) and chronic coughing. Patients with Kidney failure and Diabetes were excluded.
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Intervention groups
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Participants were divided into two groups (50 individuals in each); one group was treated with 15 g of the Prunus Dulcis Linctus ( 5 g in the morning , 5 g in the midday and 5 g at night) fot 14 days and another group took the only placebo.
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Main outcome variables
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Intensity of chronic cough in the intervention and control groups.
General information
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Reason for update
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The company for supplying the Prunus Dulcis Linctus and placebo was changed from "Salamat Kodeh Baharan Traditional Medicine" company to "Andisheh Teb Booali" company.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210315050707N1
Registration date:
2021-06-01, 1400/03/11
Registration timing:
registered_while_recruiting
Last update:
2021-07-12, 1400/04/21
Update count:
1
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Registration date
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2021-06-01, 1400/03/11
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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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Expected recruitment start date
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2021-04-21, 1400/02/01
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Expected recruitment end date
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2021-07-21, 1400/04/30
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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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Investigation the effect of the " Prunus Dulcis Linctus" on asthmatic Patients ( refractory with chronic cough)
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Public title
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Investigation the effect of the " Prunus Dulcis Linctus" on treatment of cough
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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 asthma whose cough has not been treated with common medications.
Patients over 14 years
Patients who have signed the consent form.
Exclusion criteria:
Patients with Kidney failure and Diabetes
Patients who were unavailable for follow-up
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Age
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From 14 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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This study was conducted as a single_blind. Given that the appearance of the medicinal substance containing Prunus Dulcis Linctus extract is the same as that of Placebo medicinal substance, Patient werw not informed about the nature of them and they didn't know whether thay were the main drug or Placebo.
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Placebo
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Used
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Assignment
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Parallel
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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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2021-05-17, 1400/02/27
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Ethics committee reference number
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IR.TBZMED.REC.1400.176
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
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ICD-10 code description
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Asthma
Primary outcomes
1
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Description
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Refractory Asthma
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Timepoint
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Comparison of Spirometry values as well as patient history before and two weeks after the "Prunus Dulcis Linctus" consumption.
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Method of measurement
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Spirometry test - Cough Questionnaire
Intervention groups
1
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Description
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Intervention group: the intervention group including fifty people, whose admission requirements has been confirmed according to determined criteria, was treated with 15 g of the Prunus Dulcis Linctus ( 5 g in the morning , 5 g in the midday and 5 g at night) for 14 days. Prunus Dulcis Linctus under study made by Andishe teb booali company,Iran .
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Category
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Treatment - Drugs
2
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Description
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Control group: including fifty people who their clinical features are the same as the intervention group. They received placebo instead of interventional as the same procedure as the intervention group. Placebo under study made by Andishe teb booali company, Iran .
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Category
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Placebo
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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Tabriz 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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There is not more Data for sharing.
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available