evaluation of the effect of compound "Ma-ol-asal" on clinical manifestation of the adult asthma 18-60 years old
Design
After getting Ethics committee reference number and IRCT registration, patients who have mild to moderate asthma 18-60 years that have diagnosed by lung specialist and have inclusion criteria, divide to case and control group.
Settings and conduct
taking a history.
all patients were carefully examined, completed a Asthma Control Test (ACT). The classic treatment of asthma was performed for both groups, which include the use of fluticasone spray 250/25 mcg1 puff every 12 hours. In addition to the aforementioned treatment, the experimental group also receive compound "Ma-ol-asal".
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with asthma 18-60 years old that is referred to the pulmonary clinic of the Loghman Hospital
Exclusion criteria: under 18 and over 60 years old
patients with severe asthma and require hospitalization
patients with underlying diseases such as CF,COPD, heart failure, GERD, bronchiectasis, Pulmonary embolism and sarcoidosis
Addicts to cigarettes
BMI > 29
pregnant and lactating women
Intervention groups
Asthmatic patients who receive compound "Ma-ol-asal" and classic treatment.
Asthmatic patients who receive placebo and classic treatment.
Main outcome variables
Shortness of breath
Cough
Wheez
Spray intake
Patient's function
Asthma control rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181115041664N1
Registration date:2020-05-10, 1399/02/21
Registration timing:retrospective
Last update:2020-05-10, 1399/02/21
Update count:0
Registration date
2020-05-10, 1399/02/21
Registrant information
Name
Narges Kaveh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
nkaveh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of compound "Ma-ol-asal" on clinical manifestation of the adult asthma
Public title
The effect of compound "Ma-ol-asal" on treatment of the adult asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
mild to moderate asthma
18-60 years old
Referral to the pulmonary clinic of Loghman Hospital, Tehran, Iran
Exclusion criteria:
under 18 and over 60 years old
patients with severe asthma and require hospitalization
patients with underlying diseases such as CF,COPD, heart failure, GERD, bronchiectasis, Pulmonary embolism and sarcoidosis
Addicts to cigarettes
BMI > 29
pregnant and lactating women
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Block
Randomization unit: Individual
Randomization tool: Random numbers table
How to build a sequence: In the random numbers table, the random number is selected from the table and is selected in rows or columns in the up and down and left or right directions of the next. Because amount of 4 blocks conditions for the two groups is six, the numbers are greater than 6 and the zero ignored and each digit identifies the block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients enter the study after studying and completing the form of informed consent and knowledge that drugs and placebo are not known.
The researcher does not know the drug cods for medication or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid-Beheshti University of Medical Sciences
Street address
The Office of Management Research, Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-01-06, 1397/10/16
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.828
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Breathlessness
Timepoint
Before and after the intervention
Method of measurement
Asthma control Test
2
Description
Cough
Timepoint
Before and after the intervention
Method of measurement
Asthma control Test
3
Description
Wheez
Timepoint
Before and after the intervention
Method of measurement
Asthma control Test
4
Description
Spray Intake
Timepoint
Before and after the intervention
Method of measurement
Asthma control Test
5
Description
Patient`s function
Timepoint
Before and after the intervention
Method of measurement
Asthma control Test
6
Description
Asthma control rate
Timepoint
Before and after the intervention
Method of measurement
Asthma control Test
7
Description
B.M.I
Timepoint
Before and after the intervention
Method of measurement
kg/m2
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: receiver 10cc syrup in 100cc lukewarm water, 3 times per day with Seretide spray 1 puff every 12 hours for 3 months. Each 100cc of compound honey syrup contains 2 gr. of Cinnamomum verum, 2 gr. of Elettaria cardamomum, 1 gr.Zingiber officinalRoscoe, 1 gr. Alpinia galangal and 1 gr. Crocus sativus with water and honey. Medicine is provided by Niac company.
Category
Treatment - Drugs
2
Description
Control group: Receiver 10cc placebo in 100cc lukewarm water, 3 times per day with Seretide spray 1 puff every 12 hours for 3 months. Each 100cc of placebo syrup contains 0.1% sodium benzoate, 0.1% saccharin and 0.25% C.M.G. Placebo is provided by Niac company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman hospital
Full name of responsible person
Narges Kaveh
Street address
Shams Alley, Valiasr Avenue
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8877 3521
Email
sitm@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rasool Choopani
Street address
Shahid Beheshti University of Medical Sciences, Next to Taleghani Hospital, Evin, Shahid Chamran Highway, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8877 3521
Email
sitm@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Kaveh
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8877 3521
Email
arash27.nk@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rasool Choopani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8877 3521
Email
rchoopani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Kaveh
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8877 3521
Email
arash27.nk@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We have not got any plans for dispersion.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available