Objective: Determine the efficacy of Plantago major and Almond gum on clinical symptoms and Pulmonary function tests in patients with resistant to treat Asthma.
Design study: non-randomized, not-blind, non- placebo controlled, multi center, Phase 2 clinical trial
The method of study:
Inclusion criteria: Resistant to treat Asthma in step 4, Dry cough.
Exclusion criteria: Unstable asthma, Upper respiratory tract infection, Gut Obstruction, Pregnancy and lactation, Concurrent use of other immunosuppressive drugs
Target sample size: 25
Interventions: Diagnostic spirometry before and after treatment, Treatment with therapeutic package containing plantain seed and Almond gum.
Time of intervention: 6 weeks.
Outcomes: Reduce or improve in Asthma symptoms regarding spirometry, Asthma control test, and Asthma quality of life questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012026117N1
Registration date:2017-01-31, 1395/11/12
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-01-31, 1395/11/12
Registrant information
Name
Masoumeh Kaboli Farshchi
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2081
Email address
kabolifm911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ُStudy the effect of Plantago major and Almond gum on clinical symptoms and Pulmonary function tests in patients with resistant to treat Asthma
Public title
Effect of a herbal medicine combination in resistant to treat Asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Resistant to treat Asthma in step 4, Dry cough
Exclusion criteria: Unstable asthma; Upper respiratory tract infention; Gut Obstruction; Pregnancy and lactation; Concurrent use of other immunosuppressive drugs.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah Avenue, Central Building, Mashhad University of Medical Sciences, University Ethics Committee
City
Mashhad
Postal code
Approval date
2016-06-11, 1395/03/22
Ethics committee reference number
IR.MUMS.REC.1395.181
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.0
ICD-10 code description
Predominantly allergic asthma Allergic: bronchitis NOS rhinitis with asthma Atopic asthma Extrinsic allergic asthma Hay fever with asthma
Primary outcomes
1
Description
Asthma symptoms
Timepoint
Before and six weeks after intervention
Method of measurement
AQLQ and ACT Questionnaires
Secondary outcomes
1
Description
Airway obstruction
Timepoint
Before and 6 weeks after intervention
Method of measurement
Spirometry
Intervention groups
1
Description
Intervention group: Oral drug:Powder of almond gum and plantago major seeds;
Dose: 5 grams of pack contains 3 grams of almond gum powder and 2 grams of plantago major seed, every 8 hours, the duration of treatment (consumption): 6 weeks; How to use: Patients should dissolve the content of each pack in 150 cc warm water and consume it after 30 minute by maintaining an hour away from food.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Clinic
Full name of responsible person
Dr Farahzad Jabbari Azad, Allergy and Clinical Immunologist, Associate Professor
Street address
Special Clinic for Allergic diseases, Dr shariati Sq, Parastar St, Mashhad, Khorasan Razavi
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi, Research Vice Chancellor
Street address
Vice Chancellery for Research of Mashhad University of Medical Sciences, Golestan Crossroad, Daneshgah Ave, Mashhad, Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Sadat Kaboli Farshchi
Position
PhD Student of Traditional and Complementary Medicine
Other areas of specialty/work
Street address
Six Jahad Ave, Mashhad Faculty of Traditional Medicine
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
kabolifm911@mums.ac.ir
Web page address
www.mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Anushiravani
Position
Assistant Professor
Other areas of specialty/work
Street address
6 Jahad Ave, Mashhad Faculty of Traditional Medicine
City
Mashhad
Postal code
Phone
+98 518552188
Fax
Email
Anushiravanim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Sadat Kaboli Farshchi
Position
PhD Student of Traditional and Complementary Medicine
Other areas of specialty/work
Street address
Six Jahad Ave, Mashhad Faculty of Traditional Medicine
City
Mashhad
Postal code
9135913556
Phone
+98 51 3855 2188
Fax
+98 51 3853 5980
Email
kabolifm911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)