1. Home
  2. Approved trials
  3. » فارسی

Investigating the effect of Plantago major on clinical symptoms of Ulcerative colitis

Protocol summary

Study aim
Investigating the effect of Plantago major on clinical symptoms of Ulcerative colitis
Design
Double blind clinical trial.The eligible persons of patients with symptoms of Ulcerative colitis, that confirmed by colonoscopy and biopsy, will be chosen and then will be randomly categorized into intervention or control group.Finally,the effect of Plantago major on severity of disease symptoms will be evaluated.Intervention group:Prescribed chemical drugs with Plantago major and Control group: Prescribed chemical drugs with placebo.Sample size:50 Phase:3
Settings and conduct
Site:Gastroentrology clinic, Imam Khomeiny hospital, Urmia.General Mizaj in 0, 8 w., Severity of symptoms in 0, 4, 8 w. according to Lichtiger Clinical Index,and Drug side effects in 4, 8 w.,will be evaluated.Research fellow and participants are blinded to drug type.
Participants/Inclusion and exclusion criteria
Include:1.Having the clinical symptoms of Ulcerative colitis that confirmed by endoscopy and biopsy2.Age 15-70 years Exclude:1.Pregnancy or breast feeding2.Massive bleeding or need to hospitalization or emergent surgery3.Fulminant colitis, Peritonitis, Toxic megacolon, Colorectal cancer, Stricture, Obstruction4.Using of Antibiotics, Herbal drugs,OCPs, NSAIDs or Hormonal therapy(in last 2 weeks(w.))5.Concurrent important and severe disease:liver, kidney or heart disease, cancer or Celiac disease6.Cigarette or opioids addiction
Intervention groups
Intervention group: Capsule 600mg of Plantago major roasted seed, 2 cap. 30 minutes before meals(totally 6 cap. in day), up to 8 w. and Control group: Capsule 600mg of roasted Wheat flour, 2 cap. 30 minuts before meals(totally 6 cap. in day), up to 8 w..All of the patients have their prescript chemical drugs.
Main outcome variables
Severity of clinical symptoms of Ulcerative colitis (remission, mild, moderate, sever)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181018041375N1
Registration date: 2018-12-17, 1397/09/26
Registration timing: registered_while_recruiting

Last update: 2018-12-17, 1397/09/26
Update count: 0
Registration date
2018-12-17, 1397/09/26
Registrant information
Name
Atiyeh Baghizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 4055
Email address
a.baghizadeh@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-10, 1397/09/19
Expected recruitment end date
2019-06-09, 1398/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Plantago major on clinical symptoms of Ulcerative colitis
Public title
Effect of Plantago major on Ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having the clinical symptoms of Ulcerative colitis that confirmed by endoscopy and biopsy Age 15-70 years
Exclusion criteria:
Pregnancy or breast feeding Massive bleeding or need to hospitalization or emergent surgery Fulminant colitis, Peritonitis, Toxic megacolon, Colorectal cancer, Stricture, Obstruction Using of Antibiotics, Herbal drugs,OCPs, NSAIDs or Hormonal therapy(in last 2 weeks) Concurrent important and severe disease:liver, kidney or heart disease, cancer or Celiac disease Cigarette or opioids addiction
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The expert of center,accomplish the permuted block randomization(quadruple blocks) and codification of boxes(1 to 50), and the research fellow hands over the boxes to patients sequentially, while she is unaware of their content.Due to blinding, the last allocation in each block stays confidential.
Blinding (investigator's opinion)
Double blinded
Blinding description
The research fellow and participant are blinded to boxes contents(drug or placebo),and the boxes are handed over sequentially due to their codes(double blind trial)
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee on Research of Shahed University
Street address
Shahed University, Opposite to Imam Khomeini holy shrine, Persian Gulf highway (Tehran-Qom), Tehran
City
Tehran
Province
Tehran
Postal code
33191​18651
Approval date
2018-09-03, 1397/06/12
Ethics committee reference number
IR.SHAHED.REC.1397.037

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
Severity of clinical symptoms of Ulcerative colitis (remission, mild, moderate, sever)
Timepoint
0, 4, 8 weeks
Method of measurement
Lichtiger Clinical Index

Secondary outcomes

1

Description
Drug side effects
Timepoint
4, 8 weeks
Method of measurement
Drug side effects questionnaire

2

Description
General Mizaj
Timepoint
0, 8 weeks
Method of measurement
Mojahedi Mizaj questionnaire

Intervention groups

1

Description
Intervention group: Prescribed chemical drugs with capsule 600mg of Plantago major roasted seed, 2 cap. 30 minuts before meals(totally 6 cap. in day), up to 8 weeks
Category
Treatment - Drugs

2

Description
Control group: Prescribed chemical drugs with capsule 600mg of roasted Wheat flour, 2 cap. 30 minuts before meals(totally 6 cap. in day), up to 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroentrology clinic, Imam Khomeiny hospital
Full name of responsible person
Atiyyeh Baaghizadeh
Street address
Imam Khomeini hospital, Ershad Ave., Modarres Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Fax
+98 44 3345 7277
Email
emam-h-urm@umsu.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Imam Khomeini holy shrine, Persian Gulf highway (Tehran-Qom), Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5105
Email
info@shahed.ac.ir
Web page address
http://shahed.ac.ir/research/Pages/Home.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Aiyyeh Baaghizadeh
Position
PhD Candidate of Iranian Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shahed University, Opposite to Imam Khomeini holy shrine, Persian Gulf highway (Tehran-Qom), Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4055
Email
a.baghizadeh@shahed.ac.ir
Web page address
http://shahed.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Ali Davaati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
College of Medicine, Shahed University, Opposite to Imam Khomeini holy shrine, Persian Gulf highway (Tehran-Qom), Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2600
Email
a_davati@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Atiyyeh Baaghizadeh
Position
PhD Candidate of Iranian Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shahed University, Opposite to Imam Khomeini holy shrine, Persian Gulf highway (Tehran-Qom), Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4055
Fax
+98 21 5121 4056
Email
a.baghizadeh@shahed.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
Loading...