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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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History
# Registration date Revision Id
4 2023-01-27, 1401/11/07 254201
3 2023-01-23, 1401/11/03 253770
2 2020-09-22, 1399/07/01 151973
1 2019-03-08, 1397/12/17 82438
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  • Protocol summary

    Competition of efficacy of traditional remedy of Trachyspermum copticum and Apium graveolence with hydroalcoholic extraction and Domperidone tablet on clinical symptoms of patients with postprandial distress syndrome
    Competition of efficacy of traditional remedy of Trachyspermum copticum and Apium graveolence with Domperidone tablet on clinical symptoms of patients with postprandial distress syndrome
    مقایسه تأثیر فرآورده سنتی کرفس و زنیان با عصاره هیدروالکلی کرفس و زنیان و قرص دومپریدون بر علائم بالینی بیماران مبتلا به سندرم ناراحتی پس از غذاخوردن
    مقایسه تأثیر فرآورده سنتی کرفس و زنیان با قرص دومپریدون بر علائم بالینی بیماران مبتلا به سندرم ناراحتی پس از غذاخوردن
    بیماران مبتلا به شندرم ناراحتی پس از غذاخوردن پس از مراجعه به بیمارستان افضلی پور، براساس معیارهای ورود و عدم ورود به صورت تصادفی (تصادفی بلوکی) وارد مطالعه می شوند. تهیه، بسته بندی و کدگذاری داروها توسط داروساز انجام می شود و بیمار و محقق در مورد نوع مداخله کور هستند.
    بیماران مبتلا به سندرم ناراحتی پس از غذاخوردن پس از مراجعه به بیمارستان افضلی پور، براساس معیارهای ورود و عدم ورود به صورت تصادفی (تصادفی بلوکی) وارد مطالعه می شوند. تهیه، بسته بندی و کدگذاری داروها توسط داروساز انجام می شود و بیمار و محقق در مورد نوع مداخله کور هستند.
    -Intervention group: traditional remedy of Trachyspermum copticum and Apium graveolence, 1 gr daily, for 4 weeks -Control group 1: hydrialcoholic extraction of 1 gr Trachyspermum copticum and Apium graveolence, daily, for 4 weeks - Control group 2: Domperidone tablet 10 mg, 30 mg daily, for 4 weeks
    -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
    - گروه مداخله: فرآورده سنتی کرفس و زنیان، 1 گرم در روز، به مدت 4 هفته - گروه کنترل 1: عصاره هیدروالکلی 1 گرم کرفس و زنیان در روز، به مدت 4 هفته - گروه کنترل 2: قرص دومپریدون 10 میلیگرمی، 30 میلی گرم در روز به مدت 4 هفته
    - گروه مداخله: فرآورده سنتی کرفس و زنیان، 1 گرم در روز، به مدت 4 هفته - گروه کنترل: قرص دومپریدون 10 میلیگرمی، 30 میلی گرم در روز به مدت 4 هفته

  • General information

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    Change in the methods and start date
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    تغییر در روش کار و زمان شروع مطالعه
    Patients are referred to a group of 25 blocks with 6 random sequences, respectively. Sequences are based on the repetition of each of the three groups A, B, and C. 25 blocks are randomly placed on the list. The patient will be referred to the list, respectively. for example: AABBCC, ABACBC,..
    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,..
    بیماران به ترتیب مراجعه در یک گروه از 25 بلوک با 6 توالی تصادفی قرار می گیرند. توالی ها براساس تکرار هر یک از سه گروه A ، B و C ساخته می شوند. 25 بلوک به صورت تصادفی ساده در لیست قرار می گیرند. بیمار به ترتیب ورود به مطالعه در لیست قرار می گیرند. به عنوان مثال: AABBCC, ABACBC,..
    بیماران به ترتیب مراجعه در یک گروه از 6 بلوک با 4 توالی تصادفی قرار می گیرند. توالی ها براساس تکرار هر یک از دو گروه A و B ساخته می شوند. 6 بلوک به صورت تصادفی ساده در لیست قرار می گیرند. بیمار به ترتیب ورود به مطالعه در لیست قرار می گیرند. به عنوان مثال: AABB, ABAB,..

  • Intervention groups

    #1
    Treatment - Drugs
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    Control group: Hydroalcoholic extraction of Apium Graveolense beans 110 mg plus Trachyspermum Copticum beans 110 mg, three times daily,after meal, for 4 weeks
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    گروه کنترل: عصاره هیدروالکلی 110 میلی گرم دانه کرفس و 110 میلی گرم دانه زنیان، سه بار در روز، بعد از هر وعده غذا، به مدت 4 هفته
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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: 2020-09-22, 1399/07/01
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
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: 100
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
Not 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

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
1 month after request
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