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Evaluation the effect of squill oxymel, Traditional Medicine product, in the treatment of moderate to severe asthma in patients 18 to 70 years old: triple-blind randomized Clinical trial

Protocol summary

Summary
The purpose of this study is to evaluate the effect of Squill Oxymel in the patients with asthma. The study is a randomized, triple-blind and single-center which will be carried out on 51 patients with moderate to severe asthma referred to Imam Khomeini Hospital. Inclusion criteria include: age 18 to 50 years, treated with conventional medications and patients with moderate to severe asthma that was insufficiently controlled despite treatment with medium or high dose inhaled corticosteroids. Exclusion criteria include: add or remove the drugs that interfere with asthma (NSAIDs and corticosteroids) and infections leading to hospitalization. Method: with randomization (blocks), Patients will be divided into 3 groups of 17 people: Intervention Group 1 (Squill Oxymel, Oral Syrup, 10 ml twice a day), Intervention Group 2 (simple Honey Oxymel, Oral Syrup, 10 ml twice a day) and Control Group (placebo). Patients will be treated for 6 weeks. The Primary outcomes included quality of life and FEV1. Secondary outcomes included the FEV1 / FVC, RV, TLC, RV / TLC and RAW. These changes will be assessed with the quality of life questionnaires St. George (SGRQ), spirometry breathing test and wind box before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014111119912N1
Registration date: 2015-02-12, 1393/11/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-02-12, 1393/11/23
Registrant information
Name
Hossein Karegar-Borzi
Name of organization / entity
College of Traditional Medicine of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2298 8550
Email address
h-karegar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-02-14, 1393/11/25
Expected recruitment end date
2015-06-15, 1394/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of squill oxymel, Traditional Medicine product, in the treatment of moderate to severe asthma in patients 18 to 70 years old: triple-blind randomized Clinical trial
Public title
Evaluation of the effect of squill oxymel In asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 to 70 years; asthma patients with moderate to severe asthma who have clinical criteria include: FEV1 between 40% to 80% of the predicted and asthma that was insufficiently controlled despite treatment with medium or high dose inhaled corticosteroids; treated with conventional drugs; Lack of pregnancy; Lack of breastfeeding; Lack of the use other herbal medicines; Lack of active peptic ulcer and cardiovascular disease (especially heart block) or renal disease; Not concomitant use of anticoagulant; Non-smoking. Exclusion criteria: Add or remove the drugs that interferes with asthma (such as NSAIDs); Infections leading to hospitalization; the patient's unwillingness to continue treatment.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, Keshavarz Ave., Tehran
City
Tehran
Postal code
Approval date
2014-11-09, 1393/08/18
Ethics committee reference number
9021309004-126326

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
asthma

Primary outcomes

1

Description
asthma quality of life
Timepoint
Before and after the intervention (end of week 6)
Method of measurement
St. George's Respiratory Questionnaire (SGRQ)

2

Description
FEV1
Timepoint
Before and after the intervention (end of week 6)
Method of measurement
Spirometry testing

Secondary outcomes

1

Description
FEV1/FVC
Timepoint
Before and after the intervention (end of week 6)
Method of measurement
Spirometry testing

2

Description
RV (Residual Volume)
Timepoint
Before and after the intervention (end of week 6)
Method of measurement
body box plethysmography

3

Description
TLC (total lung capacity)
Timepoint
Before and after the intervention (end of week 6)
Method of measurement
body box plethysmography

4

Description
RV/TLC
Timepoint
Before and after the intervention (end of week 6)
Method of measurement
body box plethysmography

5

Description
RAW total (Resistance Air Way total)
Timepoint
Before and after the intervention (end of week 6)
Method of measurement
body box plethysmography

6

Description
RAW in, ex (Resistance Air Way)
Timepoint
Before and after the intervention (end of week 6)
Method of measurement
body box plethysmography

Intervention groups

1

Description
Intervention Group1 (Medication): Squill Oxymel (traditional medicine products)Oral Syrup (250ml), 10 ml twice a day for 6 weeks
Category
Treatment - Drugs

2

Description
Intervention Group2 (Medication): simple Honey OxymelOral Syrup (250ml), 10 ml twice a day for 6 weeks
Category
Treatment - Drugs

3

Description
Control Group (placebo): a mixture of honey, water, color additive, etc. Oral Syrup (250ml), 10 ml twice a day for 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mehrnaz Asadi
Street address
Keshavarz Blvd., Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
College of Traditional Medicine of Tehran University of Medical Sciences
Full name of responsible person
Dr. Roja Rahimi
Street address
College of Traditional Medicine of Tehran University of Medical, Behesht Street, Vahdat Eslami Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
College of Traditional Medicine of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hossein Karegar-Borzi
Position
PhD Student of Traditional Medicine
Other areas of specialty/work
Street address
College of Traditional Medicine of Tehran University of Medical Sciences, Behesht Street, Vahdat Eslami Street
City
Tehran
Postal code
Phone
+98 21 5563 9724
Fax
Email
h-karegar@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hossein Karegar-Borzi
Position
PhD Student of Traditional Medicine
Other areas of specialty/work
Street address
College of Traditional Medicine of Tehran University of Medical Sciences, Behesht Street, Vahdat Eslami Street
City
Tehran
Postal code
Phone
+98 21 5563 9724
Fax
Email
h-karegar@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hossein Karegar-Borzi
Position
PhD Student of Traditional Medicine
Other areas of specialty/work
Street address
College of Traditional Medicine of Tehran University of Medical Sciences, Behesht Street, Vahdat Eslami Street
City
Tehran
Postal code
Phone
+98 21 5563 9724
Fax
Email
h-karegar@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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