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Comparision of effectiveness of Teucrium polium and placebo on Total IBS symptom Score, abdominal pain severity, bloating and spasm in patients with Irritable Bowel Syndrome

Protocol summary

Summary
General objective: Determination of the effect of Teucrium polium capsule on Total IBS Symptom Score, abdominal pain severity, spasm, and bloating in patients with IBS Design of study: randomized, double blind, placebo controlled trial. Method of study: A) the study population: the patients with IBS have admitted in Ziaeian Hospital would be passed inclusion criteria can participate in study. This patients will be divided randomized in two group. the first Group will be used Teucrium polium capsule for one month, the second group will be used placebo (starch) capsule for one month. Before and after intervention Total IBS Symptom Score, abdominal pain severity, spasm, bloating and LFT will be recorded, analysised at the end of study. Inclusion criteria: age between 18 - 65 years old; receiving written informed consent from patients; having IBS. Exclusion criteria: individuals will not to continue the study; any chronic diseases (cardiac disease, prostate hyperplasia, kidney failure, liver disease, glaucoma); having allergy to herbal products (specially including Teucrium polium); any use of herbal medications in last 3 months; pregnancy. B)Sample size: 70 ( will be divided randomized in two 35 patients group). C)intervention in study: Teucrium capsule & placebo capsule D)duration of intervention: one month E) the primary out come: reduce of severity of abdominal pain & Total IBS Symptom Score after intervention

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082529327N4
Registration date: 2017-10-23, 1396/08/01
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-10-23, 1396/08/01
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Researcher
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of effectiveness of Teucrium polium and placebo on Total IBS symptom Score, abdominal pain severity, bloating and spasm in patients with Irritable Bowel Syndrome
Public title
The effect of Teucrium polium on Irritable Bowel Syndrome symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 - 65 years old; receiving written informed consent from patients; having IBS. Exclusion criteria: individuals will not to continue the study; any chronic diseases (cardiac disease, prostate hyperplasia, kidney failure, liver disease, glaucoma); having allergy to herbal products (specially including Teucrium polium); any use of herbal medications in last 3 months; pregnancy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
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 of Islamic Azad University of Pharmaceutical Sciences
Street address
#99,The First of Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Postal code
19395-6466
Approval date
2017-05-08, 1396/02/18
Ethics committee reference number
IR.IAU.PS.REC.1397.87

Health conditions studied

1

Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58 , K58.
ICD-10 code description
Irritable bowel syndrome,Irritable bowel syndrome with diarrhoea, Irritable bowel syndrome without diarrhoea

Primary outcomes

1

Description
Total IBS symptom Score
Timepoint
before intervention, one month after intervention
Method of measurement
questionnaire

2

Description
abdominal pain severity
Timepoint
before intervention, one month after intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
spasm
Timepoint
before intervention, one month after intervention
Method of measurement
questionnaire

2

Description
bloating
Timepoint
before intervention, one month after intervention
Method of measurement
questionnaire

Intervention groups

1

Description
intervention group: in people with inclusion criteria to be given 250 mg oral Teucrium polium capsule , 4 times daily , for one month.
Category
Treatment - Drugs

2

Description
control group: in people with inclusion criteria to be given oral placebo capsule (contain 250 mg of Starch powder) 4 times daily for one month.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
Roghayeh Mahdi
Street address
Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Roghayeh Mahdi
Full name of responsible person
Roghayeh Mahdi
Street address
Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Roghayeh Mahdi
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
Islamic Azad University of Pharmaceutical Sciences
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Other areas of specialty/work
Street address
#99, the first of Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Postal code
19395-6466
Phone
+98 21226400515
Fax
Email
r_abrishami@iaups.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
islamic Azad University of Pharmaceutical Sciences
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Other areas of specialty/work
Street address
#99, The first of Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Postal code
19395-6466
Phone
+98 21226400515
Fax
Email
r_abrishami@iaups.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Pharmaceutical Sciences
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Other areas of specialty/work
Street address
#99, The first of Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Postal code
19395-6466
Phone
+98 21226400515
Fax
Email
r_abrishami@iaups.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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