We decide to treat IBS symptoms with camomile. In a randomized clinical trial, 45 patients who fulfilled the ROOM II criteria and had no organic disease enrolled in this study and were asked to take Chamomile 20 drops daily for four weeks.
Exclusion criteria:
history of sensitivity to milk and its products, other active illnesses
They were asked to fill in IBS-associated symptoms questionnaire to specify abdominal pain intensity, bloating, nausea, stool consistency and altered bowel habits. The questionnaire was filled out during 5 visits: at the first day, at the second and fourth weeks after starting the treatment and also the second and fourth weeks after the end of intervention. We expect that symptoms must be better or relief totally.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106206842N1
Registration date:2012-06-27, 1391/04/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-27, 1391/04/07
Registrant information
Name
Shahram Agah
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 2214
Email address
sh-agah@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-09-28, 1388/07/06
Expected recruitment end date
2010-10-17, 1389/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Chamomile Efficacy in relief of symptoms of Irritable Bowel Syndrome in Patients with Irritable Bowel Syndrome
Public title
Chamomile Efficacy in Irritable Bowel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of IBS (with diarrhea or constipation dominancy); no history of sensitivity to milk and its products, age between 10 to 50 years; willingness to participate; no other active illness (specially asthma); no drug consumption (specially anticoagulants); no psychiatric illness; not having pregnancy or doing breast feeding; no history of hyper sensitivity; no current therapy for IBS; and no abnormal lab data (CBC/ ESR/ CRP/ TSH).
Exclusion criteria:
history of sensitivity to milk and its products; other active illnesses(specially asthma); any psychiatric illnesses; history of hypersensitivity; current therapy for IBS; any abnormal lab data(CBC/ESR/CRP/TSH)
Age
From 10 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethic committee of Medical School of Tehran University of Medical sciences
Street address
Tehran University of Medical Science- Hemmat highway,next to Milad Hospital
City
Tehran
Postal code
Approval date
2010-12-21, 1389/09/30
Ethics committee reference number
896/5
Health conditions studied
1
Description of health condition studied
irritable bowel syndrome
ICD-10 code
K58.0, K58
ICD-10 code description
Irritable bowel syndrome with diarrhoea, Irritable bowel syndrome without diarrhea
Primary outcomes
1
Description
frequency of bowel habit
Timepoint
every two weeks
Method of measurement
questionare
2
Description
abdominal pain
Timepoint
every two weeks
Method of measurement
questionare
Secondary outcomes
1
Description
distention
Timepoint
every two weeks
Method of measurement
questionare
Intervention groups
1
Description
45 patients who fulfilled the ROOM II criteria and had no organic disease enrolled in this study and were asked to take Chamomile 20 drops daily for four weeks. They were asked to fill in IBS-associated symptoms questionnaire to specify abdominal pain intensity, bloating, nausea, stool consistency and altered bowel habits
Category
Treatment - Other
2
Description
a prospective pre-post study in camomile use
The drop was produced by Soha Jissa Company Tehran, Iran and contained bizabulol and camazolen (69.47 mg/100cc). The patients used the drop for 4 weeks, 10 drops each 12 hours, 15 minutes after meal. They had to solve it in warm water.
Category
Treatment - Drugs
3
Description
This intervention dont have any control group. This study is a comparing method between before and after camomile use in patients who use camomile.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoolakram Hospital
Full name of responsible person
Dr Shahram Agah
Street address
Shahrara; Nyayesh Ave.; Sattarkhan Str.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhoondzadeh
Street address
Central Department of Tehran University Of Medical Sciences
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, Medical School
Full name of responsible person
dr Reyhaneh Asadi
Position
research assistant in research faculty of medical sciences, general practitionare
Other areas of specialty/work
Street address
Poorsina Ave., Medical School 1st floor research faculty
City
Tehran
Postal code
Phone
+98 21 6405 3405
Fax
Email
reyhane_asadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
shahram agah
Position
gastroenterologist
Other areas of specialty/work
Street address
Tehran hemmat airway medical school educational faculty
City
Tehran
Postal code
Phone
+98 21 8860 2214
Fax
Email
sh-agah@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
reyhaneh asadi
Position
MD,research assistant
Other areas of specialty/work
Street address
medical school,research faculty
City
Tehran
Postal code
Phone
+98 21 6405 3405
Fax
Email
reyhane_asadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)