Asthma is characterized by frequent episodes of shortness of breath, wheezing and coughing. The management of asthma is based on avoidance of the trigger factors, oral and inhaled medications albeit some herbals. Ziziphus spina-christi(L.) used for bronchitis and coughing. It had never been investigated in clinical trials to evaluate the efficacy in asthmatic patients. The aim of this study is to evaluate the effect of Z.spina–christi leaf extract in adult asthmatic patients. A randomized, double blind, placebo control, parallel clinical trial to compare the extract with placebo in moderate to severe asthmatic patients. 50 previously diagnosed asthmatic patients and stable on current therapies were randomly divided in 2 arms. Placebo group and extract group; 25 patients in each arm who are on regular repeat medications plus placebo or extract and were used twice a day on alternate days as a steam inhalation. The Pulmonary Function Test (PFT) and St George’s questionnaire were completed at base line. Follow up weekly for a period of 2 month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311173106N14
Registration date:2014-01-22, 1392/11/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-22, 1392/11/02
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Pharmaceutical Sciences branch of Islamic Azad University, 2- investigators financial sources
Expected recruitment start date
2012-09-15, 1391/06/25
Expected recruitment end date
2013-09-01, 1392/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Managemnt of adult asthma:a randomized-double blind -placebo controlled-parallel trial of Ziziphus spina christi leaf extract
Public title
Study of the effect of inhaled extract of ziziphus spina christi leaf in asthmetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of asthma diagnosis; the patients who signature satisfaction letter of ethical committee; stable on current therapy.
Exclusion criteria: another respiratory complications; lung cancer; acute infection and exacerbation; pregnancy; non agreements and non cooperatives.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic azad university-pharmaceutical science branch
Street address
N99,Yasaman alley,Yakhchal st, shariati st,
City
Tehran
Postal code
Approval date
2012-08-30, 1391/06/09
Ethics committee reference number
11849
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.8
ICD-10 code description
Mixed asthma
Primary outcomes
1
Description
FEV1
Timepoint
After 1month and after 2 months
Method of measurement
By liter and by spirometry machinery
Secondary outcomes
1
Description
Assessment of quality of life
Timepoint
After 1 month and 2 months
Method of measurement
ST George respiratory questionnaire
Intervention groups
1
Description
The patients who are on regular repeat medication,had used Ziziphus spina christi leaf extract by the route of steam inhalation,2o drops of extract in half of liter of water for 15 minutes twice a day on alternate days for 2 month.
Category
Treatment - Drugs
2
Description
The patients who are on regular repeat medication,had used placebo by the route of steam inhalation,2o drops of extract in half of liter of water for 15 minutes twice a day on alternate days for 2 month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali hospital
Full name of responsible person
Street address
Damavand street, Emam hosein square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad university-pharmaceutical science branch
Full name of responsible person
Dr. Mehdi Rajabi
Street address
No.99,Yasaman alley,Yakhchal st.,Shariati st.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad university-pharmaceutical science branch
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad university -pharmaceutical science branch
Full name of responsible person
Dr. Mehdi Rajabi
Position
PhD-Assistant professor
Other areas of specialty/work
Street address
Yasaman alley, yakhchal st, shariati st,
City
Tehran
Postal code
Phone
+98 21 2260 9043
Fax
Email
mehdirj@aol.co.uk
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)