Project goal: investigation of Ajwain extract efficacy in relieving annoying symptoms of patients with IBS.
Desing of study: non-Randomized, non-blind, without placebo control, single-centre, phase 0 trial.
Study group: patients with irritable bowel syndrome (IBS).
Major inclusion criteria: to be in accordance with
the Rome II criteria.
Major exclusion criteria: presence of concurrent disease and organ dysfunction, pregnancy and breastfeeding, showing evidence of allergy to the plant.
Sample size: 60 patients.
Study intervention/interventions: intake of edible capsule containing Ajwain fruit extract, 15 minutes before each meal.
Intervention period: 4 weeks.
Primary outcome or outcomes of the study: abdominal pain; severity of nausea; painful defecation; presence of mucus in stool; changes in stool consistency; stool frequency and pain with defecation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030626938N1
Registration date:2016-03-27, 1395/01/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-27, 1395/01/08
Registrant information
Name
Mahdi Vazirian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6412 1223
Email address
vazirian_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-03-18, 1395/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of Ajwain fruit extract efficacy in management of symptoms of patients with Irritable Bowel Syndrome (IBS): A Case Series Study
Public title
Effect of Ajwain fruit extract in imroving irritable bowel syndrome (IBS) symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: based on ROME II criteria and presence of abdominal pains, at least for 12 consecutive or inconsecutive weeks, which includes at least one of the 3 following criteria: 1- relief with defecation; 2- changes in frequency of stool; 3- changes in stool consistency .
Exclusion criteria: concurrent disease (including chronic pulmonary disease, asthma, diabetes, thyroid disease or mental disease); pregnancy or breastfeeding and presence of sensitivity or allergic reactions to umbelliferae family; lack of patient cooperation in the treatment process.
Age
From 18 years old to 70 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Assessment of medication effect is based on patients symptoms before, and 2 and 4 weeks after treatment initiation and also 2 and 4 weeks after treatment termination.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qods street corner, Keshavarz Blvd, Tehran, Iran.
City
Tehran
Postal code
Approval date
2016-03-05, 1394/12/15
Ethics committee reference number
IR.TUMS.REC.1394.2147
Health conditions studied
1
Description of health condition studied
Irritable Bowel Syndrome (IBS)
ICD-10 code
K58
ICD-10 code description
Irritable colon
Primary outcomes
1
Description
Abdominal pain
Timepoint
Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention
Method of measurement
Severity of pain reported by the patient (Mild, Moderate, Severe) in questionnaire
2
Description
Severity of Nausea
Timepoint
Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention
Method of measurement
Severity of nausea reported by the patient (Mild, Moderate, Severe) in questionnaire
3
Description
Painful defecation
Timepoint
Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention
Method of measurement
Report of the patient (Yes/No) in questionnaire
4
Description
Presence of mucus in feces
Timepoint
Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention
Method of measurement
Report of the patient (Yes/No) in questionnaire
5
Description
Changes in feces consistency
Timepoint
Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention
Method of measurement
Report of the patient (Changed/Unchanged) in questionnaire
6
Description
Change in frequency of stool
Timepoint
Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention
Method of measurement
Report of frequency of defecation by the patient in questionnaire
Secondary outcomes
1
Description
Pain with defecation
Timepoint
Before intervention, 2 weeks after intervention, 4 weeks after intervention, 2 weeks after cessation of intervention and 4 weeks after cessation of intervention
Method of measurement
Report of the patient (Mild, Moderate, Severe) in questionnaire
Intervention groups
1
Description
Prescription of edible capsule containing hydroalcoholic extract of Ajwain fruit, based on 3 grams of the fruit, 3 times a day for 4 consecutive weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Traditional Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Karimi
Street address
Faculty of Traditional Medicine, Tehran University of Medical Sciences, Giti alley, Vafamanesh Ave., Heravi Sq., Pasdaran Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahdi Vazirian
Street address
Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Mahdi Vazirian
Position
PhD of Pharmacognosy
Other areas of specialty/work
Street address
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
City
Tehran
Postal code
Phone
+98 21 6412 1223
Fax
Email
Vazirian_m@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
Mahdi Vazirian
Position
PhD of Pharmacognosy
Other areas of specialty/work
Street address
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
City
Tehran
Postal code
Phone
+98 21 6412 1223
Fax
Email
Vazirian_m@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
Mahdi Vazirian
Position
PhD of Pharmacognosy
Other areas of specialty/work
Street address
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
City
Tehran
Postal code
Phone
+98 21 6412 1223
Fax
Email
Vazirian_m@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)