Determining the effect of ginger powder on clinical symptoms in patients with functional dyspepsia and comparing it with placebo group
Design
Clinical trial with control group, with parallel groups, triple blind, randomized, phase 2-3 on 70 patients, GraphPad software was used for randomization.
Settings and conduct
After obtaining informed consent for each member of the case and control groups, patients will rank the severity of their symptoms as a pre test.
Members of the case group will be given capsules of ginger powder and members of the control group will be given capsules of placebo by the person who distribute capsules.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having Functional dyspepsia, in the age range of 20-60 years, no change in normal diet, do not take NSAIDs, kcl, tetracycline
Exclusion criteria: having esophagitis and erosion and peptic ulcer and IBS,
Intervention groups
Case group: 250 mg ginger powder.
Control group: 250 mg placebo.
Main outcome variables
Clinical signs of functional dyspepsia include feeling full after eating, feeling full early, feeling epigastric pain, burning sensation in the epigastrium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201103049246N1
Registration date:2020-12-25, 1399/10/05
Registration timing:registered_while_recruiting
Last update:2020-12-25, 1399/10/05
Update count:0
Registration date
2020-12-25, 1399/10/05
Registrant information
Name
sina Hassannezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3387 9935
Email address
doctorsina1996@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study on efficacy of ginger on clinical manifestations in patient with Functional Dyspepsia
Public title
Ginger in functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have the functional dyspepsia disease
Not taking NSAIDs, kcl , tetracycline
Be at age range of 20-60
Not changing normal daily diet
Exclusion criteria:
Have esophagitis, peptic erosion and ulcer, IBS
Age
From 20 years old to 60 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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
First, the sequences will be determined by using GraphPad software. These sequences will be kept by a person who has no role in other parts of the research. It will be written inside the envelope in a closed and opaque way. Each of these codes falls into one of two groups, A or B. Each patient then will be given their own envelope, which they will give to the person in charge of delivering the medicine. The person in charge of delivering the medicine , depending on the name of the group in which they are located (A or B), will give the medicine of the same part. In each of these parts is either a placebo or capsules containing ginger. In this way, the doctor and the person in charge of drug delivery and patients will not be informed about the type of capsule delivered.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study patients, researcher, Statistics specialist and Physician examining clinical signs will be unaware of the groups allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tabriz university of medical sciences
Clinical sign's of Functional dyspepsia which include feeling full in the stomach after a meal, feeling full early, feeling epigastric pain and burning sensation in the epigastrium.
Timepoint
At the beginning of the study and 4 weeks after starting capsules which contain Ginger's powder
Method of measurement
Questionnaire prepared from common symptoms of the Functional dyspepsia disease
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group members will be given 250 mg capsule of Ginger's powder (produced by GOLDARU factory of Esfahan with the brand name of Zintoma) 3 capsule daily for 4 weeks.
Category
Treatment - Drugs
2
Description
Control group: 3 capsules of 250 mg placebo daily for 4 weeks, patients will complete their disease symptoms as a pre test- posttest.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastrointestinal and Liver Disease Research center at Imam Reza hospital of Tabriz
Full name of responsible person
Dr.Mohammad Hossein Somi
Street address
Gastrointestinal and Liver Disease Research center, Floor two, Emergency building, Imam Reza Medical Education Center, Golghast Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 7499
Email
lgdrc2005@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
liver and gastrointestinal disease research center, floor two, emergency building, Imam Reza Medical Education Center, Golghast Street, Azadi Avenue, Tabriz