The aim of this study is to assess the effectiveness of almond on improvement of symptoms in IBS patients. Criteria for entering the study: Criteria for entering the study are the presence of Rome III cirrhosis, which include: pain; recurrent abdominal discomfort for at least three days a month in the last three months, with the elimination of two of the following: defecation with bowel movements; The onset of symptoms with a change in the frequency of bowel movements; the onset of symptoms along with a change in the stool shape; withdrawal criteria for patients who did not take the medicine on a regular basis; patients who did not complete the assessment form completely. The study candidates are patients who refer to Afzalipour hospital from October 2016 to October 2017. A number of 50 patients were randomized into two groups of intervention which receives almond granules (40g/day) for 20 consecutive days and placebo group which receive equal wheat flour granules daily for 20 days.the patients will be evaluated through a data assessment form respect to symptoms of abdominal pain intensity and consequence, bowel movement frequency and bloating severity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070234861N1
Registration date:2017-10-09, 1396/07/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-09, 1396/07/17
Registrant information
Name
Fariba Sharififar
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5020
Email address
fsharififar@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Kerman University of Medical Sciences
Expected recruitment start date
2016-12-20, 1395/09/30
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of almond fruit (Prunus amygdalus L.) on sevirity of symptoms in irritable bowel syndrome
Public title
effect of almond fruit in IBS patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Criteria for entering the study are the presence of Rome III cirrhosis, which include: pain; recurrent abdominal discomfort for at least three days a month in the last three months, with the elimination of two of the following: defecation with bowel movements; The onset of symptoms with a change in the frequency of bowel movements; the onset of symptoms along with a change in the stool shape;
Exclusion criteria
withdrawal criteria for patients who did not take the medicine on a regular basis; patients who did not complete the assessment form completely
Age
No age limit
Gender
Both
Phase
N/A
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
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Deputy
Street address
Tahmase Abad Crossroads, Ibn Sina Avenue
City
kerman
Postal code
7619813159
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IRKMUREC139601195
Health conditions studied
1
Description of health condition studied
irritable bowel syndrome
ICD-10 code
K58.0
ICD-10 code description
Irritable bowel syndrome with diarrhoea
Primary outcomes
1
Description
pain location
Timepoint
20 day
Method of measurement
Data validation form
2
Description
pain consequency
Timepoint
days 0 and 20
Method of measurement
data evaluation form
3
Description
pain consequency
Timepoint
days 0 and 20
Method of measurement
data evaluation form
4
Description
pain intensity
Timepoint
days 0 and 20
Method of measurement
data evaluation form
Secondary outcomes
1
Description
Buttal in daily functio
Timepoint
20 day
Method of measurement
Data validation form
2
Description
.pain intensity
Timepoint
days 0 and 20
Method of measurement
data evaluation form
3
Description
analgesic drug taking
Timepoint
days 0 and 20
Method of measurement
data evaluation form
Intervention groups
1
Description
The intervention group containsf 25 patients treated with sachets containing 40 grams of almond granules daily for 20 days
Category
Treatment - Drugs
2
Description
Placebo group recieved equal amount of wheat flour granul daily for 20 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Dr. Fariba Sharififar
Street address
Imam Highway Afzalipour Hospital
City
kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences, Vice Chanellor of Research
Full name of responsible person
Dr. Mehdi Ansari
Street address
Faculty of Pharmacy
City
Kerman
Grant name
Grant code / Reference number
95/00500
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences, Vice Chanellor of Research
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
Afzalipour Hospital
Full name of responsible person
Mahnaz Azimipour
Position
medical student
Other areas of specialty/work
Street address
Imam Highway Afzalipour Hospital
City
kerman
Postal code
7616914111
Phone
+98 34 3132 8000
Fax
+98 33222763
Email
mahnazazimi20@yahoo.com
Web page address
www.kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Pharmacy
Full name of responsible person
Dr. Fariba Sharififar
Position
Associate Professor
Other areas of specialty/work
Street address
Faculty of Pharmacy
City
kerman
Postal code
76175493
Phone
+98 34 3132 5002
Fax
+98 31325003
Email
Fa.sharififar@gmail.com
Web page address
www.kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Medical School
Full name of responsible person
Mahnaz Azimipour
Position
Medical Student
Other areas of specialty/work
Street address
Imam Blvd.
City
kerman
Postal code
7616914111
Phone
+98 34 3132 8000
Fax
+98 33222763
Email
mahnazazimi20@yahoo.com
Web page address
www.kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)