Evaluating the efficacy of Persian medicine processed Bunium persicum on functional dyspepsia.
Design
Randomized, superiority, controlled group trial with blinded outcome assessment with a parallel group design of 45 patients, Randomization by using the random block method, with a ratio of 1:1 and as one of the four blocks.
Settings and conduct
Kermani cumin seeds are prepared from a local herbal products shop and after confirming the quality and species of the sample by a pharmacognosy specialist, they are used in the preparation of the product. First, after cleaning and washing, we soak the seeds in twice the volume of Barij essence grape vinegar for 24 hours. Then dry the grain mixture in Aven at 37° C for 24 hours. Roast and powder the dried seeds and after passing through a 30 mesh sieve, it is supplied to the patient in the form of 500 mg capsules twice a day.
Control group capsules contain corn starch. Drugs are prepared in the Faculty of Pharmacy of Kerman University of Medical Sciences and are packaged and coded in the same way. The person in charge of the coding has no role in the study until the end of the intervention. Patients will be selected by someone not knowing the coding method. This clinical trial is performed in Kerman Afzalipour hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients between 18 and 60 years old who are suffering from functional indigestion and do not have the exclusion criteria, who have consciously signed the consent form.
Exclusion criteria: organic gastrointestinal disorders, use of anticoagulant, serious organic, or mental disorders.
Intervention groups
Intervention group: 500 mg cumin powder, twice a day for 4 weeks
Control group: Capsules containing 500 mg of starch powder, twice a day for 4 weeks
Main outcome variables
Severity and frequency of dyspepsia, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210602051471N1
Registration date:2022-01-09, 1400/10/19
Registration timing:registered_while_recruiting
Last update:2022-01-09, 1400/10/19
Update count:0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
Saeed Moghtaderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3251 0958
Email address
s.moghtaderi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-04, 1400/10/14
Expected recruitment end date
2022-07-05, 1401/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of Persian medicine processed Bunium persicum on functional dyspepsia.
Public title
Evaluating the efficacy of Bunium persicum on functional dyspepsia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 18 and 60 years old who are suffering from functional indigestion and do not have the exclusion criteria.
Who have consciously signed the consent form.
Exclusion criteria:
Organic gastrointestinal disorders
use of anticoagulant drugs
Serious organic, or mental disorders
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will enter the study using the random block method, with a ratio of 1:1 and as one of the four blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
The whole process of pharmacology will be done by a third person who does not have any role in finding patients and data analysis. The medicine and the placebo are packed similarly and after being given a code (as four blocks) will be available for the researcher. The data analysis will be conducted by a person who is not concerned about the groups under intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Sciences
Street address
Afzalipour Hospital, Emam khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Approval date
2021-08-30, 1400/06/08
Ethics committee reference number
IR.KMU.REC.1400.300
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
Dyspepsia symptoms severity score
Timepoint
4 times: With arrival, after 2 , 4 and 8 weeks
Method of measurement
Dyspepsia symptoms severity questionnaire
2
Description
Dyspepsia symptoms frequency
Timepoint
4 times: With arrival, after 2 , 4 and 8 weeks
Method of measurement
Dyspepsia symptoms frequency questionnaire
3
Description
Quality of life
Timepoint
3 times: With arrival, after 4 and 8 weeks
Method of measurement
Dyspepsia quality of life questionnaire
Secondary outcomes
1
Description
Drug side effects
Timepoint
With arrival until the end of follow-up period
Method of measurement
Drug side effects questionnaire
Intervention groups
1
Description
Intervention group: Bunium persicum powder capsules, 500 mg, twice a day, for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: Corn starch capsules, 500 mg, twice a day, for 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
مریم عظیمی
Street address
Emam Khomeini Highway, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3325 7651
Email
dr.azimm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abas Pardakhti
Street address
Vice Chancellor for Research, Kerman University of Medical Sciences, Jahad St., Somayeh 4-way
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3231 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
Saeed Moghtaderi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 7, 12th Alley, Abouzar St.
City
Kerman
Province
Kerman
Postal code
7617875396
Phone
+98 34 3251 0958
Email
s.moghtaderi@kmu.ac.ir
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
Emam Khomeini Highway, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3325 7651
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
Saeed Moghtaderi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 7, 12th Alley, Abouzar St.
City
Kerman
Province
Kerman
Postal code
7617875396
Phone
+98 34 3251 0958
Email
s.moghtaderi@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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