Protocol summary
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Study aim
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Competition of efficacy of traditional remedy of Trachyspermum copticum and Apium graveolence with Domperidone tablet on clinical symptoms of patients with postprandial distress syndrome
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Design
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Clinical trial with community-based and control group, with parallel groups, double blind, randomized
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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-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
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Main outcome variables
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Symptom severity and quality of life
General information
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Reason for update
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Change in the methods and start date
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Acronym
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IRCT registration information
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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
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Registration date
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2019-03-08, 1397/12/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-02-20, 1397/12/01
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Expected recruitment end date
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2019-09-23, 1398/07/01
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Actual recruitment start date
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2020-02-01, 1398/11/12
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Actual recruitment end date
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2020-08-31, 1399/06/10
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Trial completion date
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2020-08-31, 1399/06/10
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Scientific title
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Efficacy of Apium graveolense and Trachyspermum copticum versus Domperidone on clinical symptoms of patients with postprandial distress syndrome
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Public title
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Efficacy of Apium graveolense and Trachyspermum copticum on postprandial syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
100
Actual sample size reached:
96
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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,..
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-05-28, 1397/03/07
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Ethics committee reference number
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IR.KMU.REC.1397.069
Health conditions studied
1
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Description of health condition studied
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Functional dyspepsia
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ICD-10 code
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K30
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ICD-10 code description
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Functional dyspepsia
Primary outcomes
1
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Description
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Severity assessment of dyspepsia
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Timepoint
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4 times: baseline, 2,4 and 8 weeks
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Method of measurement
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The gastrointestinal severity symptom scale
2
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Description
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Quality of life
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Timepoint
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3 times: baseline, 4, 8 weeks
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Method of measurement
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NDI10 quality of life scale
3
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Description
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Frequency assessment of dyspepsia
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Timepoint
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4 times: baseline, 2,4 and 8 weeks
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Method of measurement
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Rome IV questionnaire
Secondary outcomes
1
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Description
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Side effects
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Timepoint
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During 8 weeks study
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Method of measurement
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Side effects questionnnaire
Intervention groups
1
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Description
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Intervention group: Apium Graveolense beans 110 mg plus Trachyspermum Copticum beans 110 mg, three times daily,after meal, for 4 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Domperidone tablet 10 mg, three times daily, after meal, for 4 weeks
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kerman University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Articles
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When the data will become available and for how long
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6 months after printing of Articles
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To whom data/document is available
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Academic and Industrial Researchers
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Under which criteria data/document could be used
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Demographic and symptom severity and quality of life information
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From where data/document is obtainable
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E-mail
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What processes are involved for a request to access data/document
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1 month after request
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Comments
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