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General information
Not used
Used
nusedused
100
96
10096
Protocol summary
Study aim
Competition of efficacy of traditional remedy of Trachyspermum copticum and Apium graveolence with Domperidone tablet on clinical symptoms of patients with postprandial distress syndrome
Design
Clinical trial with community-based and control group, with parallel groups, double blind, randomized
Settings and conduct
Patients with Postprandial Distress Syndrome after referring to Afzalipour hospital, based on entry and non-entry criteria, randomly (block randomization) enter the study. Preparation, packaging and coding of drugs are done by the pharmacist, and patients and researcher are blind to the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- 18-60 years old patients
- Patients with postprandial distress syndrome based on Rome IV criteria
Non-entry criteria:
- Pregnancy and lactation
- History of gastrointestinal surgery
- History of convulsion
- Use of anti coagulant drugs
- Use of other chemical or herbal medicine for dyspepsia.
Intervention groups
-Intervention group: traditional remedy of Trachyspermum copticum and Apium graveolence, 1 gr daily, for 4 weeks
- Control group: Domperidone tablet 10 mg, 30 mg daily, for 4 weeks
Main outcome variables
Symptom severity and quality of life
General information
Reason for update
Change in the methods and start date
Acronym
IRCT registration information
IRCT registration number:IRCT20150927024228N2
Registration date:2019-03-08, 1397/12/17
Registration timing:prospective
Last update:2023-01-29, 1401/11/09
Update count:3
Registration date
2019-03-08, 1397/12/17
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
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2020-02-01, 1398/11/12
Actual recruitment end date
2020-08-31, 1399/06/10
Trial completion date
2020-08-31, 1399/06/10
Scientific title
Efficacy of Apium graveolense and Trachyspermum copticum versus Domperidone on clinical symptoms of patients with postprandial distress syndrome
Public title
Efficacy of Apium graveolense and Trachyspermum copticum on postprandial syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 60 year-old patients with functional dyspepsia
Presence of symptoms of postprandial distress syndrome
Exclusion criteria:
Pregnancy and Lactation
History of convulsion
Use of chemical and herbal drugs of dyspepsia
Serious diseases like diabetes and cardiovascular diseases
History of gastrointestinal surgery
Severe mental retardation
Drug abuse
Use of anticoagulant drug
History of side effects related to use of herbal or chemical medicines
History of peptic ulcer or gastrointestinal reflux disease
Presence of any structural disorder in endoscopy during the last three months
Presence of irritable bowel syndrome
The patient's unwillingness to continue the study, or unwillingness to signing the concent form
Presence of any alarming sign (severe weight loss, anemia, bloody stool, difficult swallowing
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Actual sample size reached:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are referred to a group of 6 blocks with 4 random sequences, respectively.
Sequences are based on the repetition of each of the two groups A, and B 6 blocks are randomly placed on the list. The patient will be referred to the list, respectively. for example: AABB, ABAB,..
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications are packaged and encoded by a third person who does not have a role until the end of the study and the researcher does not know about encoding. The general nature of the intervention groups is described to the patients before starting the study, But there is no information about the details of the group in which they are located.
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
Province
Kerman
Postal code
7616913555
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.KMU.REC.1397.069
Health conditions studied
1
Description of health condition studied
Functional dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia
Primary outcomes
1
Description
Severity assessment of dyspepsia
Timepoint
4 times: baseline, 2,4 and 8 weeks
Method of measurement
The gastrointestinal severity symptom scale
2
Description
Quality of life
Timepoint
3 times: baseline, 4, 8 weeks
Method of measurement
NDI10 quality of life scale
3
Description
Frequency assessment of dyspepsia
Timepoint
4 times: baseline, 2,4 and 8 weeks
Method of measurement
Rome IV questionnaire
Secondary outcomes
1
Description
Side effects
Timepoint
During 8 weeks study
Method of measurement
Side effects questionnnaire
Intervention groups
1
Description
Intervention group: Apium Graveolense beans 110 mg plus Trachyspermum Copticum beans 110 mg, three times daily,after meal, for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: Domperidone tablet 10 mg, three times daily, after meal, for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipur Hospital
Full name of responsible person
Maryam Azimi
Street address
Emam khomeini High way; kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 8000
Email
Dr.Azimm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Pardakhti Abbas
Street address
Shafa Crossroad; Jomhuri Boulevard; Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5041
Email
Abpardakhty@kmu.ac.ir
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
Maryam Azimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Amirkabir Crossroad; Jomhuri Boulevard; Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3211 0123
Email
Dr.azimm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Azimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Amirkabir Crossroad; Jomhuri Boulevard; Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 43 3211 0123
Email
Dr.azimm@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Azimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Amirkabir Crossroad; Jomhuri Boulevard; Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3211 0123
Email
Dr.azimm@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Articles
When the data will become available and for how long
6 months after printing of Articles
To whom data/document is available
Academic and Industrial Researchers
Under which criteria data/document could be used
Demographic and symptom severity and quality of life information
From where data/document is obtainable
E-mail
What processes are involved for a request to access data/document