Objective: Dyspnea in Traditional Persian medicine and evaluation and comparison the effect of camel milk and standard treatment on symptoms in asthma patients. Design: randomized, single blind phase 2-3 trial study. setting and conduct: a- participants including major eligibility criteria - major inclusion criteria: asthma patients - major exclusion criteria: severe drug reactions; non-compliance with the prescribed milk; smoking or other drug uses; suffering from other underlying diseases; hospital admittion; pregnancy; discourage patients from continuing to participate in the plan - sample size: 46 patients b- intervention: 500 cc camel milk daily with standard asthma treatment c- intervention time: 3 months d- main outcome: change of clinical finding, change of spirometry, change of ACT (asthma control test) questionnaire. These parameters will be evaluated again after completing the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102930541N1
Registration date:2017-01-25, 1395/11/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-25, 1395/11/06
Registrant information
Name
Mohammad Ravaghi
Name of organization / entity
Persian Traditional Medicine Student
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2188
Email address
ravaghim911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences ,Vice chancellor for research
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dyspnea in Traditional Persian Medicine and evaluation and comparison the effect of camel milk and standard treatment on symptoms in asthma patients
Public title
The effect of camel milk on asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 15-40; asthma diagnosis according to spirometry and hystory. Exclusion criteria: severe drug reactions; non-compliance with the prescribed milk; smoking or other drug uses; suffering from other underlying diseases; hospital admittion; pregnancy; discourage patients from continuing to participate in the plan.
Age
From 15 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Mashhad University of Medical Sciences
Street address
Ethics committee of Mashhad University of Medical sciences, central office of Mashhad University of Medical Sciences, Daneshgah ave., Mashhad, Iran
City
Mashhad
Postal code
Approval date
2016-05-28, 1395/03/08
Ethics committee reference number
IR.MUMS.REC.1395.61
Health conditions studied
1
Description of health condition studied
asthma
ICD-10 code
J45
ICD-10 code description
asthma
Primary outcomes
1
Description
asthma symptoms
Timepoint
before treatment, one and two month after treatment and after treatment
Method of measurement
ACT questionnaire
2
Description
FEV1
Timepoint
before treatment, one and two month after treatment and after treatment
Method of measurement
spirometry
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group we prescribe salbutamol or salmetrol and fluticasone inhaler according to asthma degree and camel milk 250 cc two times a day for 3 months.
Category
Treatment - Drugs
2
Description
In control group we prescribe salbutamol or salmetrol and fluticasone inhaler according to asthma degree for 3 months without placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Traditional and Complementary Medicine clinic
Full name of responsible person
Mohammad Ravaghi
Street address
Faculty of Traditional and Complementary Medicine, Razi sharghi ave., 10 Dey sq., Mashhad, Iran
City
Mashad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences ,Vice chancellor for research
Full name of responsible person
Said Islame
Street address
Ghoreishi building, Daneshgah street, University of Medical Sciences, Vice chancellor for research, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences ,Vice chancellor for research
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, Faculty of Traditional and Complementary Medicine
Full name of responsible person
Mohammad Ravaghi
Position
Persian Traditional Medicine student
Other areas of specialty/work
Street address
Faculty of Traditional and Complementary Medicine, Razi sharghi ave., 10 Dey sq., Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51385521889
Fax
+98 51 3853 5980
Email
ravaghim911@mums.ac.ir; dr_ravaghi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Internal Medicine Department, Ghaem hospital, Mashhad University of Medical Sciences
Full name of responsible person
Seyyd Musa Al-Reza Hosseini
Position
Subspecialist of Gastroenterology
Other areas of specialty/work
Street address
Department of Internal Medicine, Ghaem hospital, Ahmadabad street, Mashhad
City
Mashhad
Postal code
Phone
+98 51384000009
Fax
+98 51 3801 2742
Email
hoseinimr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Traditional and Complementary Medicine
Full name of responsible person
Mohammad Ravaghi
Position
Persian Traditional Medicine student
Other areas of specialty/work
Street address
Faculty of Traditional and Complementary Medicine, Razi sharghi ave., 10 Dey sq., Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
+98 51 3853 5980
Email
ravaghim911@mums.ac.ir; dr_ravaghi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)