Determination of the Effect of ColiT Relife's Traditional Medicine on Preventing Recurrence of Symptoms in Patients with Ulcerative Colitis
Design
Patients in two divided groups receive both sulfasalazine 2.5 to 3 grams per day and folic acid tablets daily, and the prednisone treatment starts with TAPER in both groups of 10 mg per day. The first group with this 250 mg capsule regimen receives placebo once a day and the second group will receive the COLIT RELIF traditional medicine in the form of a capsule of 250 mg daily taken with food. Patients will receive it before and then every two weeks after the start The case study was conducted and clinical symptoms and the rate of recurrence in both groups were evaluated by filling in the SCCAI questionnaire.
Settings and conduct
Patients are given a gastroenterologist with a history, examination, colonoscopy, and histological examination of moderate to severe ulcerative colitis. They fit with the criteria for inclusion in the study, and after complete explanation of the study and obtaining personal consent Enter the study. Patients from medical clinics in Isfahan and Yazd were randomly divided into two groups by computer coding.
Participants/Inclusion and exclusion criteria
For patients, the diagnosis of infectious colitis is caused by Clostridium deficiency colitis, ischemic colitis, and drug dependent colitis.
Patients with moderate to severe ulcerative colitis were diagnosed in the last month of the REMISSION phase.
Failure to use other complementary and alternative therapies
Intervention groups
The intervention group also used Prednisolone and Cefalazine for the traditional medicine product COLIT RELIF.
Main outcome variables
1) The results of this study could be used to propose a new treatment protocol for ulcerative colitis.
2) Proof of scientific validity and efficacy of traditional Iranian medicine in the treatment of ulcerative colitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171211037832N1
Registration date:2018-06-01, 1397/03/11
Registration timing:retrospective
Last update:2018-06-01, 1397/03/11
Update count:0
Registration date
2018-06-01, 1397/03/11
Registrant information
Name
Fateme Rezayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3724 0171
Email address
f.rezayat@hsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-27, 1395/10/07
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
2016-12-27, 1395/10/07
Actual recruitment end date
2017-10-23, 1396/08/01
Trial completion date
empty
Scientific title
THE EFFECT OF IRANIAN TRADITIONAL MEDICINE PRODUCT(COLIT RELIEF) IN PREVENTION THE RELAPSE OF ULCERATIVE COLITIS PAITIENT
Public title
The effect of traditional medicine COLIT RELIF in patients with ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
For patients, the diagnosis of infectious colitis is caused by Clostridium deficiency colitis, ischemic colitis, and drug dependent colitis.
Patients with moderate to severe ulcerative colitis were diagnosed in the last month of the REMISSION phase.
Failure to use other complementary and alternative therapies
Completion of consent form in an informed manner
Exclusion criteria:
Pregnancy or breastfeeding
The creation of a drug complication or allergy
Dissatisfaction with the continuation of treatment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The research is experimental and experimental for 10 weeks for each patient. Patients were randomly assigned to two groups of 19 patients and 21 subjects divided into two groups: TAPERING, prednisolone 10 mg starting with 10 mg Sulfasalazine They also receive 2.5 to 3 grams per day. Our control group, along with its routine, received placebo in a 250 mg capsule once a day, and in the intervention group, traditional medicine COLIT RELIF was added to the patient's drug regimen in the form of a 250 mg capsule once a day.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The present study is three-blind. This blindness was done by the patient, the pharmacist, and the person who analyzed the data.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
Central Organization of Yazd University of Medical Sciences. Shahid Bahonar Square
The results of this study could be used to propose a new treatment protocol for ulcerative colitis.
Timepoint
Effect of traditional medicine coliT relife before intervention and in weeks 2, 4, 6, 8 and 10 after intervention
Method of measurement
Regular medical check-ups
Secondary outcomes
1
Description
Proof of scientific validity and efficacy of traditional Iranian medicine in the treatment of ulcerative colitis
Timepoint
Before intervention and weeks 2, 4, and 6, 8 and 10 after intervention
Method of measurement
Regular patient visit and opinion form
Intervention groups
1
Description
Intervention group: Intervention group: The product of traditional medicine COLIT RELIF is presented in the form of a 250 mg capsule once a day along with food and also prednisolone starting at a dose of 10 mg plus sulfasalazine with a dose of 2.5 to 3 grams per day
Category
Treatment - Drugs
2
Description
Control group: Control group: Placebo in the form of a 250 mg capsule once a day as well as prednisolone started at a dose of 10 mg plus sulfasalazine with a dose of 2.5 to 3 grams per day...
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Yazd and Isfahan
Full name of responsible person
Majid Emtiazy
Street address
Faculty of Traditional Medicine, Imam Khomeini street, Ardakan
City
Ardakan
Province
Yazd
Postal code
8951737915
Phone
+98 35 2723 8917
Email
dr.emtiazy@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Majid Emtiazy
Street address
Faculty of Traditional Medicine, Imam Khomeini street, Ardakan
City
Ardakan
Province
Yazd
Postal code
8951737915
Phone
+98 35 2723 8917
Email
dr.emtiazy@yahoo.com
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
Majid Emtiazy
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Imam Khomeini street, Ardakan
City
Ardakan
Province
Yazd
Postal code
8951737915
Phone
+98 35 2723 8917
Email
dr.emtiazy@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Majid Emtiazy
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Traditional Medicine University, Imam Khomeini street, Ardakan
City
Ardakan
Province
Yazd
Postal code
8951737915
Phone
+98 35 2723 8917
Email
dr.emtiazy@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Majid Emtiazy
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Imam Khomeini street, Ardakan.
City
Ardakan
Province
Yazd
Postal code
8951737915
Phone
+98 35 2723 8917
Email
dr.emtiazy@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The collected data includes a small fraction of the demographic characteristics and the mean clinical stability score. After being blinded, the analyst gets it.
When the data will become available and for how long
Get started two years after the results are published
To whom data/document is available
Researchers in the field of traditional medicine
Under which criteria data/document could be used
If comparing the doses of the drug between the intervention and the control, or comparing the quality of the data with the new data.
From where data/document is obtainable
Faculty of Ardakan Traditional Medicine
What processes are involved for a request to access data/document
In coordination with the Research Council and the Research and Student Vice-Chancellor of the Faculty of Traditional Medicine, Ardakan Branch, and after passing through its legal procedures.