IRCT | Comparison of efficacy of two traditional medicine, Zataria multiflora Boiss and trachyspermum Copticum (L.) Link, on Clinical symptom in patient with Irritable bowel syndrome (IBS)

Protocol summary

Study aim: The aim of the study was to evaluate the efficacy of the Zataria Multiflora and Trachyspermum Copticum capsule on clinical signs of patients with IBS compared with Mebeverine and placebo
Design: The study is a randomized double-blind placebo controlled clinical trial
Settings and conduct: The patients referring to Kerman Besat Clinic are observed by the specialist. Patients who pass inclusion criteria complete the Consent form and enter the study. Drugs are packaged and they are named A, B and C by the person who is not involved in the study. Investigator and patients will be kept unaware to the treatment each patient will receive.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Age between 18 and 60 years; Patients with IBS according to Rome III criteria for IBS; Completion of the consent form. Exclusion criteria: any chronic diseases, systemic warning signs, specific psychological and psychiatric diseases, history of abdominal surgery, familial history of gastrointestinal cancers or inflammatory bowel disease, pregnancy and breastfeeding (for women), weight loss more than 5-6% in the past month and abnormal laboratory tests
Intervention groups: Intervention group 1: receiving 750 mg of Zataria multiflora Boiss and Tracheyspermum copticum , Intervention group 2: receiving 133 milligrams of Mebeverine. Control group: receiving placebo
Main outcome variables: Severe abdominal pain; Abdominal pain; Bloating rate; Satisfaction with bowel habits; Quality of Life

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20180519039707N1

Registration date: 2018-12-01, 1397/09/10

Registration timing: registered_while_recruiting

Last update: 2018-12-01, 1397/09/10

Update count: 0
Registration date: 2018-12-01, 1397/09/10

Registrant information: Name

Hossein Jamalizadeh tajabadi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 34 3212 2239

Email address

sitm@kmu.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2018-09-06, 1397/06/15
Expected recruitment end date: 2019-03-21, 1398/01/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of efficacy of two traditional medicine, Zataria multiflora Boiss and trachyspermum Copticum (L.) Link, on Clinical symptom in patient with Irritable bowel syndrome (IBS)

Public title: Comparison of efficacy of Traditional Medicine ( Zataria multiflora Boiss. and Trachyspermum Copticum (L.) Link) on Clinical symptom in patient with Irritable bowel syndrome (IBS)
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

fulfilling Rome III criteria for IBS Completion of the consent form Being at the age of 18 to 60 years old

Exclusion criteria:

Pregnancy Breast feeding History of gastrointestinal surgery Any serious drug-related inverse effect Inevitable weight loss History of any diseases like Crohn's disease and ulcerative colitis Dyspepsia Severe mental retardation Any kind of substance abuse or alcohol consumption Not completing the consent form The occurrence of warning signs (weight loss, anemia, Hematochezia or melena, dysphagia)
Age: From 18 years old to 60 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Investigator

Sample size

Target sample size: 150

Randomization (investigator's opinion)

Randomized

Randomization description

A simple Randomization is done. The first patient receives drug A; The second patient receives drug B and the third patient receives drug C. This cycle is repeated.

Blinding (investigator's opinion)

Double blinded

Blinding description

The medicine is prepared and coded by a third person at the Faculty of Pharmacy in Kerman University of Medical Sciences. Then it is presented to the researcher and the researcher gives it to the patient. The patient and the researcher are not informed (blind) about the drug. The drug results will be decoded after extracting of the results.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Kerman University of Medical Siences

Street address

Besat Clinic, Jahad Street

City

Kerman

Province

Kerman

Postal code

7619837773
Approval date: 2018-09-14, 1397/06/23
Ethics committee reference number: IR.KMU.AH.REC.1397.082

Health conditions studied

1

Description of health condition studied: Irritable bowel syndrome
ICD-10 code: K58
ICD-10 code description: Irritable bowel syndrome

Primary outcomes

1

Description: Quality of Life (QOL)
Timepoint: before the intervention, after 4 weeks, after 6 weeks (2 weeks after the interrupting the intervention)
Method of measurement: The quality of life questionnaire (IBS-QOL-34)

2

Description: pain
Timepoint: before the intervention, after 4 weeks, after 6 weeks (2 weeks after the interrupting the intervention)
Method of measurement: Visual Analogue Scale

3

Description: flatulence
Timepoint: before the intervention, after 4 weeks, after 6 weeks (2 weeks after the interrupting the intervention)
Method of measurement: Visual Analogue Scale

4

Description: constipation
Timepoint: before the intervention, after 4 weeks, after 6 weeks (2 weeks after the interrupting the intervention)
Method of measurement: Visual Analogue Scale

5

Description: diarrhea
Timepoint: before the intervention, after 4 weeks, after 6 weeks (2 weeks after the interrupting the intervention)
Method of measurement: Visual Analogue Scale

6

Description: difficulty in bowel movements
Timepoint: before the intervention, after 4 weeks, after 6 weeks (2 weeks after the interrupting the intervention)
Method of measurement: Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group 1: consuming 750 mg capsule (Zataria multiflora Boiss and Trachyspermum Copticum (L.) Link), BID( in the morning and in the evening before meals) for 4 weeks. The response to the treatment, quality of life and the severity of symptoms are checked in each patient. This response is investigated using questionnaire before and 4 and 6 weeks after intervention.
Category: Treatment - Drugs

2

Description: Placebo group: consuming 750 mg capsule (Corn starch), BID ( in the morning and in the evening before meals) for 4 weeks. The response to the treatment, quality of life and the severity of symptoms are checked in each patient. This response is investigated using questionnaire before and 4 and 6 weeks after intervention.
Category: Placebo

3

Description: Intervention group 2: 133 mg capsule( Mebeverine ), BID( in the morning and in the evening before meals) for 4 weeks. The response to the treatment, quality of life and the severity of symptoms are checked in each patient. This response is investigated using questionnaire before and 4 and 6 weeks after intervention.
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Besat Specialized Clinic

Full name of responsible person

Hossein Jamalizade

Street address

Besat Specialized Clinic, Jahad Avenue

City

Kerman

Province

Kerman

Postal code

7619837773

Phone

+98 34 3243 5539

Fax

+98 34 3226 8622

Email

hjamalizadeh_14@yahoo.com

1

Sponsor: Name of organization / entity

Kerman University of Medical Sciences

Full name of responsible person

HosseinJamalizadeh Tajabadi

Street address

Besat Clinic, Jahad Avenue

City

Kerman

Province

Kerman

Postal code

7619837773

Phone

+98 34 3243 5539

Email

hjamalizadeh_14@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Kerman University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Kerman University of Medical Sciences

Full name of responsible person

Hossein Jamalizadeh Tajabadi

Position

Ph.D Student of Persian Medicine

Latest degree

Medical doctor

Other areas of specialty/work

Traditional Medicine

Street address

Jahad Avenue, Besat Clinic

City

Kerman

Province

Kerman

Postal code

7619837773

Phone

+98 34 3226 8622

Fax

+98 34 3226 8622

Email

hjamalizadeh_14@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Kerman University of Medical Sciences

Full name of responsible person

Hossein Jamalizadeh Tajabadi

Position

Student of Persian Medicine

Latest degree

Medical doctor

Other areas of specialty/work

Traditional Medicine

Street address

Besat Clinic, Jahad Avenue

City

Kerman

Province

Kerman

Postal code

7619837773

Phone

+98 34 3226 8622

Fax

+98 34 3226 8622

Email

hjamalizadeh_14@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Kerman University of Medical Sciences

Full name of responsible person

Hossein Jamalizadeh Tajabadi

Position

Ph.D Student of Persian Medicine

Latest degree

Medical doctor

Other areas of specialty/work

Traditional Medicine

Street address

Besat Clinic, Jahad Avenue

City

Kerman

Province

Kerman

Postal code

7619837773

Phone

+98 34 3226 8622

Fax

+98 34 3226 8622

Email

hjamalizadeh_14@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document: After the study, information on the main outcome will be shared
When the data will become available and for how long: starting 9 months after publication
To whom data/document is available: All researchers can apply to receive it.
Under which criteria data/document could be used: Data and results will be available to all researchers in order to continue the research and implementation of the irritable bowel after the publishing of results.
From where data/document is obtainable: email addresses: hjamalizadeh_14@yahoo.com
What processes are involved for a request to access data/document: after checking Confirmation of demandو file(s) will be offered during 1 weak
Comments

Comparison of efficacy of two traditional medicine, Zataria multiflora Boiss and trachyspermum Copticum (L.) Link, on Clinical symptom in patient with Irritable bowel syndrome (IBS)