The goal of this study is to prescribe Achillea wilhelmsii capsule for patients with ulcerative colitis and evaluation the efficacy of it in a randomized double blind placebo controlled clinical trial. This study is done in Emam khomeini hospital and Emam reza hospital of Kermanshah university of medical science . 44 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 Mayo score (Disease Activity Index) and a blood test for hematologic and biochemical evaluation will be done at the beginning and the end of study. Inclusion criteria: age>18- ability to swallow the capsule- patients who are not cured with Achillea wilhelmsii during a last month.-Patients who their diseases are approved by complete medical evaluation, colonoscopy, pathology and laboratory data.-Only patients with mild to moderate ulcerative colitis. Exclusion criteria: smokers- pregnant patients and nursing mothers- Patients who have to use other drugs that interference with this medication.- patients who are disposed to a serious health danger, such as severe cardiac, liver or renal diseases.- In case of appearing significant side effects- patients with severe allergy to this plant (dermatitis contact).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102620071N2
Registration date:2017-01-22, 1395/11/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-22, 1395/11/03
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
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-11-25, 1395/09/05
Expected recruitment end date
2017-02-23, 1395/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of Achillea wilhelmsii capsule in ulcerative colitis patients:a randomized double blind placebo controlled clinical trial
Public title
Evaluation the efficacy of Achillea wilhelmsii capsule in ulcerative colitis 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.(In cases which patients do not have education,the investigator should read the testimonial for them.if they are satisfied, the investigator can include them to the study.)- patients who are not cured with Achillea wilhelmsii during a last month.-Patients who their diseases are approved by complete medical evaluation, colonoscopy, pathology and laboratory data.-Only patients with mild to moderate ulcerative colitis can be include to this study. Exclusion criteria:smokers-pregnant patients and nursing mothers-patients who have to use other drugs that interference with this medication (such as systemic NSAID, antihistamins or systemic antibiotics during last 2 weeks)- patients who are suffering from other diseases in addition to ulcerative colitis that the etiology of them are oxidative stress, such as metabolic syndrome, diabetic leg ulcer, coronary arterial disease, pulmonary infection, 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 and followed to end of the study.- If a patient do not want to continue to cooperating for any reasons, he will be excluded from the study.- patients with severe allergy to this plant (dermatitis contact) will be excluded.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is performed using blocking method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah university of medical sciences
City
Kermanshah
Postal code
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
KUMS.REC.1395.448
Health conditions studied
1
Description of health condition studied
ulcerative colitis
ICD-10 code
k51.9
ICD-10 code description
Ulcerative colitis, unspecified
Primary outcomes
1
Description
number of excretion daily
Timepoint
before using the drug-2 weeks after using the drug-30 days after using the drugs
Method of measurement
based on Mayo clinic questionary and ESR,CBC,CRP
2
Description
Rate of rectal bleeding
Timepoint
before using the drug-2 weeks after using the drug-30 days after using the drugs
Method of measurement
based on Mayo clinic score, CRP, CBC, and ESR
Secondary outcomes
1
Description
photo sensitivity- gastrointestinal disorders
Timepoint
Two weeks after using the drug- 30 days after using the drug
Method of measurement
based on side effect questionary
Intervention groups
1
Description
Two capsules (each capsule contains 250 mg Achillea wilhelmsii) daily for a month, from Kermnanshah apothecary
Category
Treatment - Drugs
2
Description
Two capsules (each capsule contains 250 mg hydroxypropyl methylcellulose from Sigma company) daily for a month
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 Chancellor for Research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Behrooz Hamzeh
Street address
Vice Chancellor for 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 Chancellor for 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
Mahtab Amiri
Position
PharmacyStudent
Other areas of specialty/work
Street address
Faculty of pharmacy, Kermanshah University of Medical Sciences
City
kermanshah
Postal code
Phone
+98 83 3725 3516
Fax
Email
mahtaba942rocketmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Mohamad hosein Farzaee
Position
Associate Professor/ PhD
Other areas of specialty/work
Street address
Faculty of pharmacy, Kermanshah University of Medical Sciences
City
kermanshah
Postal code
Phone
+98 83 3426 6780
Fax
Email
mh-farzaee@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)