Determining the effect of cupping therapy in patients with functional bloating
Design
Two parallel group randomized trial with a table of random numbers
Settings and conduct
Patients with bloating referred to a specialized gastroenterology clinic, who meet the inclusion criteria, with the approval of a gastroenterologist, are entered into the study. According to the statistical consultant, patients are randomly placed in one of the two research groups based on the table of random numbers. The first group receives 40 mg dimethicone capsules every 8 hours for two weeks, and the second group is cupped twice a week for two weeks, with dimethicone 40 mg capsules every 8 hours for two weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients aged 18 to 55 years who have symptoms of bloating and have both of the following two criteria according to ROME 4:
1- Feeling of frequent bloating, sense of fullness, or increased abdominal distention, that these symptoms occur at least 1 day a week and overcome other symptoms.
2- The onset of symptoms should be at least 6 months before the diagnosis and the predominant symptoms (bloating or distention) have been present for the past 3 months.
Exclusion criteria:
1. Pregnancy or breastfeeding in women
2. Acute or chronic diseases of the gastrointestinal tract
3. Celiac disease
4. functional dyspepsia
5. irritable bowel syndrome
Intervention groups
Interventional group1: Dimethicone capsule consisted of 40mg Dimethicone, three times a day (TID), 2 weeks
Interventional group2: abdominal cupping therapy with the use of 40mg Dimethicone, TID, 2 weeks
Main outcome variables
Severity of bloating; frequency of bloating
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200925048832N1
Registration date:2020-10-22, 1399/08/01
Registration timing:registered_while_recruiting
Last update:2020-10-22, 1399/08/01
Update count:0
Registration date
2020-10-22, 1399/08/01
Registrant information
Name
Mohammad Saeed Kalantari Meybodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3223 8916
Email address
saeedkalantari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-06, 1399/07/15
Expected recruitment end date
2020-12-05, 1399/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cupping in patients with functional bloating
Public title
The effect of cupping in functional bloating
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged 18 to 55 years who have symptoms of bloating and have both of the following two criteria according to ROME 4.
1. Feeling of frequent bloating, sense of fullness, or increased abdominal distention, that these symptoms occur at least 1 day a week and overcome other symptoms.
2. The onset of symptoms should be at least 6 months before the diagnosis and the predominant symptoms (bloating or distention) have been present for the past 3 months.
Exclusion criteria:
Pregnancy or breastfeeding in women
Acute or chronic diseases of the gastrointestinal tract
Celiac disease
functional dyspepsia
irritable bowel syndrome
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Before sampling, using the table of random numbers, which will be given two numbers 1 and 2, and number 1 as the control group and number 2 as the intervention group, and the samples in the order of the numbers given by this software, they will be placed in groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Ethics committee of Yazd University of Medical Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2020-06-23, 1399/04/03
Ethics committee reference number
IR.SSU.REC.1399.073
Health conditions studied
1
Description of health condition studied
Bloating
ICD-10 code
R14
ICD-10 code description
Flatulence and related conditions
Primary outcomes
1
Description
severity of bloating
Timepoint
Before the study, two weeks after starting the study, and two weeks after finishing the study.
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Frequency of bloating
Timepoint
Before the study, two weeks after starting the study, and two weeks after finishing the study.
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Cupping therapy will be performed four times. Each cupping therapy session time will be about 10-15 minutes. The intervention time will be fourteen days, and every three days a cupping therapy will take place. This group will also receive 40 mg dimethicone tablets made by Amin Company three times a day for two weeks.
Category
Treatment - Other
2
Description
Control group: This group receives 40 mg dimethicone tablets made by Amin Company every 8 hours for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Meybod hospital
Full name of responsible person
Mohammad Saeed Kalantari Meybodi
Street address
Basij Blvd
City
Meybod
Province
Yazd
Postal code
8961978143
Phone
+98 35 3235 1200
Fax
+98 35 3235 4025
Email
saeed7md@gmail.com
2
Recruitment center
Name of recruitment center
Ardakan hospital
Full name of responsible person
Mohammad Saeed Kalantari Meybodi
Street address
Resalat Blvd
City
Ardakan
Province
Yazd
Postal code
8951859931
Phone
+98 35 3222 2115
Email
ziaee_hospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaee
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3724 0171
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Saeed Kalantari Meybodi
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.22, Shahriar Ave, Imam sadegh Town
City
Meybod
Province
Yazd
Postal code
8961978143
Phone
+98 35 3235 4025
Fax
Email
saeedkalantari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Razieh Nabi Meybodi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3724 0171
Email
r.nabimeybodi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Saeed Kalantari Meybodi
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.22, Shahriar Ave, Imam sadegh Town
City
Meybod
Province
Yazd
Postal code
8961978143
Phone
+98 35 3235 4025
Fax
Email
saeedkalantari@ssu.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