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Clinical trial of compared of Apium Graveolence and Trachyspermum Copticum traditional product effect with placebo and omeprazol on clinical symptoms of 18 to 60 years old patients with Functional Dyspepsia

Protocol summary

Summary
This study is designed with the main aim to investigate the effect of Apium Graveolence and Trachyspermum Copticum traditional product on clinical symptoms of patients with Functional Dyspepsia, and will be performed as a randomized (Blocked randomization), double blind, placebo-control trial at one medical center in Iran; the studied groups include a group taking the Apium Graveolence and Trachyspermum Copticum traditional product, a group taking Omeprazole capsules, and a placebo group, each of which consisting of 50 FD patients, based on the ROME3 criteria. The main inclusion criteria is an age of 18 to 60 years old, whereas the main exclusion criteria is use of chemical and herbal drugs of functional dyspepsia; four weeks of administration of the drug or placebo will be conducted and a subsequent two-month follow-up observation of the primary and the secondary outcomes will be performed based on ranking the severity and frequency of gastrointestinal symptoms as well as the quality of life. Primary outcome time point will be at the baseline, 2nd, 4th, and 8th week, while the quality of life will be measured at the baseline, 4th and 8th week.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015092724228N1
Registration date: 2016-06-03, 1395/03/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-03, 1395/03/14
Registrant information
Name
Maryam Azimi
Name of organization / entity
Kerman University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3312 2020
Email address
m_azimidehali@collegian.kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research Of Kerman University Of Medical Science
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of compared of Apium Graveolence and Trachyspermum Copticum traditional product effect with placebo and omeprazol on clinical symptoms of 18 to 60 years old patients with Functional Dyspepsia
Public title
Effect of Apium Graveolence and Trachyspermum Copticum traditional product on clinical symptoms of patients with Functional Dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are 18 to 60 year-old patients with Functional Dyspepsia, without organic disorders on physical examination and endoscopy Exclusion criteria are Pregnancy and Lactation; History of convulsion; Active UTI; Use of chemical and herbal drugs of functional dyspepsia; use of anticoagulant drug;serious diseases like diabetes and cardiovascular diseases, Esophagus and gastrointestinal surgery, severe mental retardation, drug abuse, patient’s unwillingness to continue the project, not filling out the consent form History of peptic ulcer or reflux disease; Alarm sign (Weight loss, Anemia, Bloody stool, Dysphagia,etc
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 150
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 Committe of Kerman University of Medical Sciences
Street address
Shafa Crossroad; Jomhuri Boulevard; Kerman
City
kerman
Postal code
Approval date
2015-08-25, 1394/06/03
Ethics committee reference number
IR.KMU.REC.1394.233

Health conditions studied

1

Description of health condition studied
Functional Dyspepsia
ICD-10 code
K30
ICD-10 code description
Indigestion

Primary outcomes

1

Description
Severity assessment of dyspepsia
Timepoint
During 8 weeks follow up study
Method of measurement
The gastrointestinal symptom scale

2

Description
Quality of life
Timepoint
At baseline, 2, 4, 8 weeks
Method of measurement
NDI10 quality of life scale

Secondary outcomes

1

Description
Side effects
Timepoint
During 12 weeks follow up study
Method of measurement
Questionnair

Intervention groups

1

Description
Apium Graveolense beans 250 mg plus Trachyspermum Copticum beans 250 mg, two times daily,after meal
Category
Treatment - Drugs

2

Description
Corn starch 500 mg, two times daily, after meal
Category
Placebo

3

Description
Omeprazol 20 mg, daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipur Hospital
Full name of responsible person
Dr. Zahedi Mohammad Javad
Street address
Emam khomeini High way; kerman
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Kerman University of Medical Sciences
Full name of responsible person
Pardakhti Abbas
Street address
Shafa Crossroad; Jomhuri Boulevard; Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Kerman 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
Kerman University of Medical Science
Full name of responsible person
Azimidehali Maryam
Position
Resident PhD of iranian traditional medicine
Other areas of specialty/work
Street address
Shafa Crossroad; Jomhuri Boulevard; Kerman
City
Kerman
Postal code
Phone
+98 34 3312 2050
Fax
+98 34 3312 2050
Email
m_azimidehali@collegian.kmu.ac.ir, dr.azimm@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Science
Full name of responsible person
Dr. Zahedi Mohammad Javad
Position
Gastroenterologist
Other areas of specialty/work
Street address
Shafa Crossroad; Jomhuri Boulevard; Kerman
City
Kerman
Postal code
Phone
+98 34 3121 5600
Fax
+98 34 3121 5600
Email
Zahedi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Azimidehali Maryam
Position
Resident PhD of iranian traditional medicine
Other areas of specialty/work
Street address
Shafa Crossroad; Jomhuri Boulevard; Kerman
City
Kerman
Postal code
Iran
Phone
+98 34 3312 2050
Fax
+98 34 3312 2050
Email
M_azimidehali@collegian.kmu.ac.ir; dr.azimm@gmail.com
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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