The goal of this study is to prescribe Achillea wilhelmsii capsule for patients with irritable bowel syndrome and evaluating ts efficacy. This study is a randomized double blind placebo controlled clinical trial which is done in Emam khomeini hospital and Emam reza hospital of Kermanshah University of Medical Sciences .Inclusion criteria were patients with the age of more than 18; ability to swallow the capsule; patients with IBS who their disease are approved by complete medical evaluation. Exclusion criteria include pregnant patients and nursing mothers; patients with any active stomach-interic disease; patients who have to use other drugs that interference with this medication; patients who are disposed to a serious health danger; patients with severe allergy to this plant. 90 patients are treated randomly with capsules containing 250 mg Achillea wilhelmsii powder or placebo orally twice a day for 30 days. Response to the medication in patients under the treatment will be evaluated based on IBS-QOL and IBS-Severity questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110120071N3
Registration date:2016-12-29, 1395/10/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-29, 1395/10/09
Registrant information
Name
Mohammad Hosein Farzaei
Name of organization / entity
Faculty of Pharmacy, Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3825 0271
Email address
mh-farzaee@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of Achillea wilhelmsii capsule in irritable bowel syndrome patients:a randomized double blind placebo controlled clinical trial
Public title
Evaluation the efficacy of Achillea wilhelmsii capsule in irritable bowel syndrome patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : age>18 ; ability to swallow the capsule ; patients who sign the testimonials and cooperate during the study ; patients who are not cured with Achillea wilhelmsii during a last month ; Patients who their diseases are approved by complete medical evaluation.
Exclusion criteria : pregnant patients and nursing mothers ; patients with any active stomach-interic disease ; patients who have to use other drugs that interference with this medication (such as laxative، antidepressants، opioid and narcotic analgesics ) ; patients who are disposed to a serious health danger, such as severe cardiac, liver or renal diseases ; If significant side effects occur, the patient will be excluded from the study ; patients with severe allergy to this plant (dermatitis contact) will be excluded.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Kermanshah
City
Kermanshah
Postal code
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
KUMS.REC.1395.440
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrom
ICD-10 code
K58.9 , K5
ICD-10 code description
Irritable bowel syndrome with diarrhea, Irritable bowel syndrome without diarrhoea
Primary outcomes
1
Description
Diarrhea
Timepoint
Before using the drug-2 weeks after using the drug-30 days after using the drugs
Method of measurement
Based on IBS-QOL and IBS-SEVERITY questionary
2
Description
Constipation
Timepoint
Before using the drug-2 weeks after using the drug-30 days after using the drugs
Method of measurement
Based on IBS-QOL and IBS-SEVERITY questionary
3
Description
Bloat
Timepoint
Before using the drug-2 weeks after using the drug-30 days after using the drugs
Method of measurement
Based on IBS-QOL and IBS-SEVERITY questionary
4
Description
Abdominal pain
Timepoint
Before using the drug-2 weeks after using the drug-30 days after using the drugs
Method of measurement
Based on IBS-QOL and IBS-SEVERITY questionary
Secondary outcomes
1
Description
Photosensivity
Timepoint
Before start use drug-two weeks after use drug-four weeks after use drug
Method of measurement
Based on side effect questionary
2
Description
Digestive problems
Timepoint
Before start use drug-two weeks after use drug-four weeks after use drug
Method of measurement
Based on side effect questionary
Intervention groups
1
Description
Tow capsule (each capsule contain 250mg achillea wilhelmsii ) daily for a month in test group.
Category
Treatment - Drugs
2
Description
Tow capsule (each capsule contain 250mg HPMC )daily for a month in placebo group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeini Hospital, Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hosein Farzaei
Street address
Emam khomeini Hospital, Kermanshah University of Medical Sciences
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice – Chancellery of Research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Behrooz Hamzeh
Street address
Vice – Chancellery of Research, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice – Chancellery of Research, Kermanshah 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
Faculty of pharmacy, Kermanshah University of Medical Sciences
Full name of responsible person
Sayede Padide Derakhshande
Position
Student of pharmacy
Other areas of specialty/work
Street address
Faculty of pharmacy, Kermanshah University of Medical Sciences, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3426 6770
Fax
Email
padide.derakhshande73@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of pharmacy, Kermanshah University of Medical Sciences
Full name of responsible person
Dr Mohamad Hosein Farzaee
Position
Traditional medicine/ PhD
Other areas of specialty/work
Street address
Faculty of pharmacy, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Phone
+98 83 3426 6770
Fax
Email
mh.farzaei@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Pharmacy, Kermanshah University of Medical Sciences
Full name of responsible person
Sayede Padide Derakhshande
Position
Student of Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3825 0271
Fax
Email
p.derakhshande73@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)