Randomised Clinical Trial: Enteric-coated Anise-oil capsules vs. placebo & active controlled in Irritable Bowel Syndrome – A 4 week double-blind study with 2 weeks follow-up
The purpose of this study is to assess the efficacy of Enteric-coated Anise-oil capsules comparing with placebo and Colpermin® for treatment of IBS patients. 120 patients with confirmed IBS with non-response criteria selected. In this double blind pilot study, the patients and researchers will be blinded about Receiving Drug, Placebo and Active allocation. Patients will be randomized into group A (Anise-oil EC Capsule 187 mg daily, for 4 weeks), group B (placebo Capsule once daily, for 4 weeks) and group B (Colpermin® Capsule once daily, for 4 weeks). At the end of therapy (4 weeks) and at baseline (first), 2 weeks after receiving drug, placebo and Colpermin® IBS load, will be evaluated and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205069651N1
Registration date:2015-02-03, 1393/11/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-03, 1393/11/14
Registrant information
Name
Maryam Mosaffa-Jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3208 4030
Email address
mosaffam@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomised Clinical Trial: Enteric-coated Anise-oil capsules vs. placebo & active controlled in Irritable Bowel Syndrome – A 4 week double-blind study with 2 weeks follow-up
Public title
The Effect of Anise-oil capsules on IBS Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Meeting the Rome III Modular Questionnaire; Patients with 50 years were required to have a colonoscopy performed within the previous 5 years; Patients under the age of 50 years were required to have a sigmoidoscopy performed
Exclusion criteria: Unable or unwilling patients to use an acceptable method of birth control; Pregnant or nursing females; Previous gastrointestinal or abdominal surgery (except for common causes unrelated to IBS); Organic disorder of the large or small bowel (e.g. ulcerative colitis, Crohn’s disease); Mechanical obstruction; Unexplained significant weight loss or rectal bleeding; Diagnosis of any medical condition associated with constipation (other than IBS); Cancer; Abnormal laboratory tests; Abuse of alcohol or drugs
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethics Committee, Shiraz University of Medical Sciences
Street address
zand street,Shiraz University of Medical Sciences,7th floor
City
Shiraz
Postal code
Approval date
2013-03-13, 1391/12/23
Ethics committee reference number
CT-91-6460
Health conditions studied
1
Description of health condition studied
Non- Response IBS Patients
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness
Timepoint
Baseline
Method of measurement
(IBS-QOL) questionnaire and 10-point visual scale ranging
Secondary outcomes
1
Description
Change in Quality of Life (QOL), pain, flatulence, diarrhea, constipation, reflux, headache and tiredness at end of treatment
Timepoint
End of Follow Up(6 weeks after staring intervention)
Method of measurement
(IBS-QOL) questionnaire and 10-point visual scale ranging
Intervention groups
1
Description
Intervention Group: Anise-oil EC Capsule,One Cap(187mg)/day for 4 weeks. Paients will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.
Category
Treatment - Drugs
2
Description
Placebo Group: One Placebo Capsule/Day for 4 Weeks. Paients Will be Followed at Baseline, 4 and 6 Weeks after Starting Intervention.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinic, Shiraz University of Medical Sciences, Zand Avenue, Shiraz, Iran.
Full name of responsible person
Dr. Maryam Mosaffa-Jahromi
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Kamran Bagheri Lankarani
Street address
Health Policy Research Center, School of Medicine, Zand Avenue, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Health Policy Research Center
Full name of responsible person
Dr. Maryam Mosaffa-Jahromi
Position
Pharm.D, PhDc Student in Traditional Pharmacy
Other areas of specialty/work
Street address
Health Policy Research Center, School of Medicine, Zand Avenue, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 71 3230 9615
Fax
Email
mosaffam@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Health Policy Research Center
Full name of responsible person
Dr. Kamran Bagheri Lankarani
Position
Subspecialty of Gastroenterology and Faculty Member of Shiraz University of MedicalSciences, Preside
Other areas of specialty/work
Street address
Health Policy Research Center, School of Medicine, Zand Avenue, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3230 9615
Fax
Email
lankaran@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Health Policy Research Center
Full name of responsible person
Dr. Maryam Mosaffa-Jahromi
Position
Pharm.D, PhDc Student in Traditional Pharmacy
Other areas of specialty/work
Street address
Health Policy Research Center, School of Medicine, Zand Avenue, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3230 9615
Fax
+98 71 3230 9615
Email
mosaffam@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)