Protocol summary

Study aim
Determine the effect of ginger supplement on clinical status, serum levels of some inflammatory markers (TNF-α, hs-CRP), total antioxidant capacity (TAC) and expression of mir-21 in patients with active ulcerative colitis
Design
A double-blinded randomized controlled trial with two parallel groups
Settings and conduct
The clinical trial will be held at IBD clinic in the hospital, Ahvaz Jundishapur University of Medical Science, to assess the efficacy of daily 3 g ginger supplementation adjunctive in active ulcerative colitis patients.
Participants/Inclusion and exclusion criteria
Active ulcerative colitis
Intervention groups
Ginger supplementation
Main outcome variables
Clinical score Mir-21 TNF-α HsCRP TAC

General information

Reason for update
Acronym
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IRCT registration information
IRCT registration number: IRCT20190129042552N1
Registration date: 2019-06-21, 1398/03/31
Registration timing: prospective

Last update: 2019-06-21, 1398/03/31
Update count: 0
Registration date
2019-06-21, 1398/03/31
Registrant information
Name
Forough Shayesteh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3376 5113
Email address
forough_shayesteh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of ginger supplementation on clinical outcomes, serum levels of some inflammatory markers(TNF-α, hs-CRP) , TAC and expression of mir-21 in patients with active ulcerative colitis
Public title
Evaluation of the effect of ginger supplementation on clinical outcomes, serum levels of some inflammatory markers, TAC and expression of mir-21 in patients with active ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to sever active ulcerative colitis patients Absence of fulminant colitis Male and female aged 18 to 50 years Body mass index 18/5 - 30 Lack of other digestive disorders and uncontrolled disease Lack of sensitivity to ginger
Exclusion criteria:
Use of anti TNF-α Pregnancy Menopause Use of anti-coagulants, anti-diabetic and anti-blood pressure medication
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study will be done by simple method. The unit of randomization is individual. Using a random number table, a number is considered for each patient, respectively. Odd or even numbers will be allocated to the A or B group. To achieve allocation concealment, the bottles will be sealed and we will be assured from the similarity of appearance and their weight. The randomization process will be performed by an individual other than the investigators to reduce the probable bias.
Blinding (investigator's opinion)
Double blinded
Blinding description
Ginger and placebo capsules (in identical appearance container) are encoded by someone other than researcher
Placebo
Used
Assignment
Parallel
Other design features
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Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Ahvaz university of medical sciences
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
ir.ajums.rec.1397.893

Health conditions studied

1

Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

Primary outcomes

1

Description
Clinical score
Timepoint
Before and after intervention
Method of measurement
Partial mayo score

2

Description
Serum level of mir-21
Timepoint
Before and after intervention
Method of measurement
PCR

3

Description
Serum level of TNF-a
Timepoint
Before and after intervention
Method of measurement
Elisa kit

Secondary outcomes

1

Description
Serum level of hs-CRP
Timepoint
Before and after intervention
Method of measurement
Elisa kit

2

Description
Total antioxidant capacity
Timepoint
Before and after intervention
Method of measurement
Elisa kit

Intervention groups

1

Description
Intervention group: ginger supplementation 3 grams per day for 3 months
Category
Other

2

Description
Control group: placebo supplementation 3 grams daily for 3 months
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Forough shayesteh
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3333 3477
Email
Forough_shayesteh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
---
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8383
Email
behsan@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Forough shayesteh
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3333 3477
Email
Forough_shayesteh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh haidari
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3333 3477
Email
haidari58@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Forough shayesteh
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan blvd
City
Ahvaz
Province
Khouzestan
Postal code
--
Phone
--
Email
Forough_shayesteh@yahoo.com

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
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