Investigation of the effects of Zingiber officinale on quality of life, disease activity index, and Serum levels of some inflammatory factors and oxidative stress in patients with ulcerative colitis
Investigation of the effects of Zingiber officinale on quality of life, disease activity index, and Serum levels of some inflammatory factors and oxidative stress in patients with ulcerative colitis
randomized double blind placebo controlled trial
Inclusion criteria: cases with ulcerative colitis; Disease duration less than two years; active mild to moderate disease severity; no use of alcohol; Insensitivity to ginger; no disease else; no use of any dietary supplements; Anticoagulant drugs and Non-steroidal anti-inflammatory drugs (NSAIDs) during the last month; BMI over than 18.5 and less than 30; age equal and more than 18 years; tendency to participate in this research; no change in type and dose of drug usage during last month.; not pregnancy, not lactation and no use of oral contraceptive drugs in women
exclusion criteria: Relapse of disease leading to patient hospitalization; Ginger sensitivity; the patient Unwillingness to continue participation in this research.
number of cases in each group: 25 and method of sampling: Convenience Sampling
summery of implementation of plan: If patients want to participate in this study,by prior arrangement, they will come to gastrointestinal center and 12-14 h fasting blood samples will be collected, anthropometric measurements and dietary Assessment and necessary information will be gathered.
then they randomly will be divided into one of two consumer groups of ginger or placebo capsules. capsules for usage during first 6 weeks will be delivered to them. The duration of the intervention takes 12 weeks and they must consume ginger or placebo capsules 4 times per day with some water and with their meals. in the middle and at the end of 12 weeks they will come to gastrointestinal center again and 12-14 h fasting blood samples will be collected, anthropometric measurements and dietary Assessment and necessary information will be gathered. also capsules for second 6 weeks will be delivered at second meeting to them.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201703164010N17
Registration date:2017-10-17, 1396/07/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-17, 1396/07/25
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute
Expected recruitment start date
2017-04-20, 1396/01/31
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effects of Zingiber officinale on quality of life, disease activity index, and Serum levels of some inflammatory factors and oxidative stress in patients with ulcerative colitis
Public title
Investigation of the effect of ginger on ulcerative colitis treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: cases with ulcerative colitis; Disease duration less than two years; active mild to moderate disease severity; no use of alcohol; Insensitivity to ginger; no disease else; no use of any dietary supplements; Anticoagulant drugs and Non-steroidal anti-inflammatory drugs (NSAIDs) during the last month; BMI over than 18.5 and less than 30; age equal and more than 18 years; tendency to participate in this research; no change in type and dose of drug usage during last month; not pregnancy, not lactation and no use of oral contraceptive drugs in women
exclusion criteria: Relapse of disease leading to patient hospitalization; Ginger sensitivity; the patient Unwillingness to continue participation in this research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of National Nutrition and Food Technology Research Institute
Street address
National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, West Arghavan Street, Farahzadi Boulevard,Sanaat Square, Tehran
City
Tehran
Postal code
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.SBMU.NNFTRI.1395.109
Health conditions studied
1
Description of health condition studied
Ulcerative colitis
ICD-10 code
K51.9
ICD-10 code description
Ulcerative colitis, unspecified
Primary outcomes
1
Description
serum MDA
Timepoint
at the first of research. 6thweek. end of research( 12th week)
Method of measurement
Elisa
2
Description
Serum hs-CRP
Timepoint
at the first of research. 6thweek. end of research( 12th week)
Method of measurement
Elisa
3
Description
TNF-α
Timepoint
at the first of research. 6thweek. end of research( 12th week)
Method of measurement
Elisa
4
Description
TAC
Timepoint
at the first of research. 6thweek. end of research( 12th week)
Method of measurement
Elisa
5
Description
Life Quality
Timepoint
at the first of research. 6thweek. end of research( 12th week)
Method of measurement
Questionnaire
6
Description
Disease Activity Index
Timepoint
at the first of research. 6th week. end of research( 12th week)
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Weight
Timepoint
at the first of research. 6thweek. end of research( 12th week)
Method of measurement
scale
2
Description
BMI
Timepoint
at the first of research. 6thweek. end of research( 12th week)
Method of measurement
Calculation
Intervention groups
1
Description
the supplement of powdered ginger during12 weeks.4( 0.5gr) capsules daily
Category
Treatment - Other
2
Description
the capsules of placebo (starch) during12 weeks. number4( 0.5 gr) capsules daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Office of Dr.Iraj Maleki
Full name of responsible person
Dr.Iraj Maleki
Street address
Second floor of Sina Departmant,GHaran street,Sari,Mazandaran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Morteza Abdollahi
Street address
Department of National Nutrition and Food Technology Research Institute, Faculty of Nutrition Science, Shahid Beheshti University of Medical Sciences, West Arghavan Street, Farahzadi Boulevard,Sanaat Square, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Technology Research Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Position
First Executer
Other areas of specialty/work
Street address
Clinical Nutrition Department, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, West Arghavan Street, Farahzadi Boulevard,Sanaat Square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21522357483
Fax
Email
A_hekmat2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
(Department) National Nutrition and Food Technology Research Institute, Faculty of Nutrition Science
Full name of responsible person
Azita Hekmetdoost
Position
Nutritionist
Other areas of specialty/work
Street address
Clinical Nutrition Department, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, West Arghavan Street, Farahzadi Boulevard,Sanaat Square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2235 7483
Fax
Email
A_hekmat2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)