To evaluate effectiveness of Tanacetum parthenium (L) Sch. consumption on blood inflammatory and coagulating indexes
Design
Randomized controlled clinical trial with parallel groups and double blinded.
Settings and conduct
This study is conducting in Fasa and participants, researchers and analyzer are blinded to the study groups.
Participants/Inclusion and exclusion criteria
Healthy people between 20 and 60 years old who had not consume anti-inflammatory drugs and agree to participate in the study are recruited. And recent history of GI bleeding and/or surgery and side effects are exclusion criteria.
Intervention groups
For 2weeks, in drug group; capsules with 250 mg Tanacetum parthenium (L) Sch are administrated 1 time per day. And in control group; capsules with 250 mg corn flour are administrated 1 time per day.
Main outcome variables
Bleeding Time
Prothrombin Time (PT)
Partial Thromboplastin Time (PTT)
IL (1beta, 6, 8, 10, 18, 23, 33, 12p70, 17A)
INF(alpha,gama)
TNF alpha
MCP-1
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140715018490N5
Registration date:2018-08-03, 1397/05/12
Registration timing:registered_while_recruiting
Last update:2018-08-03, 1397/05/12
Update count:0
Registration date
2018-08-03, 1397/05/12
Registrant information
Name
Massih Sedigh Rahimabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3825 6275
Email address
sedighrm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-20, 1397/01/31
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate effectiveness of Tanacetum parthenium (L) Sch. consumption on blood inflammatory and coagulating indexes
Public title
Effectiveness of Tanacetum parthenium on inflammatory and coagulating indexes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between20 and 60
negative hx of D.M
negative hx of major surgery(Under 6 months)
negative hx of HTN
negative hx of coagulopathy like hemophilia
negative hx of liver diseases
Satisfaction to participate in the scheme.
not use anticoaglant drugs and anti inflamatory drugs such as NSAIDs
Not to have bleeding disorders in GI system
Exclusion criteria:
positive hx of coagulopathy like hemophilia
positive hx of HTN
positive hx of major surgery(Under 6 months)
positive hx of D.M
liver disease such as cirihosis or hepatitis
Age over 60 or under the age of 20
use anticoaglant drugs and anti inflamatory drugs such as NSAIDs
Dissatisfaction to participate in the scheme
To have bleeding disorders in GI system
possible complications
Age
From 20 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked Randomized Table
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, researchers and data analyzer were blinded to the study groups. We made the placebo and therapeutic capsules like each other and labeled them by a letter -A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Fasa University of Medical Sciences, Ebnesina square, Fasa
City
Fasa
Province
Fars
Postal code
74616-86688
Approval date
2017-10-22, 1396/07/30
Ethics committee reference number
ir.fums.rec.1396.262
Health conditions studied
1
Description of health condition studied
Healthy individuals
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Prothrombin Time (PT)
Timepoint
At the beginning of intervention, 2 weeks and 6 weeks after the beginning of intervention
Method of measurement
Venous Blood Test
2
Description
Partial Thromboplastin Time (PTT)
Timepoint
At the beginning of intervention, 2 weeks and 6 weeks after the beginning of intervention
Method of measurement
Venous Blood Test
3
Description
IL-1β
Timepoint
At the beginning of intervention and 2weeks later
Method of measurement
Venous Blood Test
4
Description
IFN-α
Timepoint
At the beginning of intervention and 2weeks later
Method of measurement
Venous Blood Test
5
Description
IFN-γ
Timepoint
At the beginning of intervention and 2 weeks later
Method of measurement
Venous Blood Test
6
Description
TNF-α
Timepoint
At the beginning of intervention and 2 weeks later
Method of measurement
Venous Blood Test
7
Description
monocyte chemotactic protein-1
Timepoint
At the beginning of intervention and 2 weeks later
Method of measurement
Venous Blood Test
8
Description
IL-6
Timepoint
At the beginning of intervention and 2 weeks later
Method of measurement
Venous Blood Test
9
Description
IL-8
Timepoint
At the beginning of intervention and 2 weeks later
Method of measurement
Venous Blood Test
10
Description
IL-10
Timepoint
At the beginning of intervention and 2 weeks later
Method of measurement
Venous Blood Test
11
Description
IL-12p70
Timepoint
At the beginning of intervention and 2 weeks later
Method of measurement
Venous Blood Test
12
Description
IL-17A
Timepoint
At the beginning of intervention and 2 weeks later
Method of measurement
Venous Blood Test
13
Description
IL-18
Timepoint
At the beginning of intervention and 2 weeks later
Method of measurement
Venous Blood Test
14
Description
IL-23
Timepoint
At the beginning of intervention and 2 weeks later
Method of measurement
Venous Blood Test
15
Description
IL-33
Timepoint
At the beginning of intervention and 2 weeks later
Method of measurement
Venous Blood Test
Secondary outcomes
1
Description
Satisfaction of patients
Timepoint
1 month after recruitment
Method of measurement
visual analog scale
2
Description
Tolerance
Timepoint
1 month after recruitment
Method of measurement
visual analog scale
3
Description
Drug side effects
Timepoint
1 month after recruitment
Method of measurement
Questionnaire
Intervention groups
1
Description
Treatment group: In this group; capsules with 250 mg Tanacetum parthenium (L) Sch are administrated 1 time per day for 2 weeks.
Category
Treatment - Drugs
2
Description
control group: In this group; capsules with 250 mg corn flour are administrated 1 time per day for 2 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fasa University of Medical Sciences
Full name of responsible person
Ebrahim Akrami
Street address
Fasa University of Medical Sciences, Ebnesina square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Fax
+98 71 5335 7091
Email
akrami_e@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Farjam
Street address
Fasa University of Medical Sciences, Ebnesina square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
akrami_e@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Ebrahim Akrami
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 34, Western Sahebolamr Ave., North Safir Blvd.
City
Shiraz
Province
Fars
Postal code
7177846939
Phone
+98 71 3820 0533
Email
akrami_e@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Ataollahi
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Fasa University of Medical Sciences, Ebnesina square, Fasa, Fars, Iran
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
ataollahimr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Ebrahim Akrami
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 34, Western Sahebolamr Ave., North Safir Blvd.
City
Fasa
Province
Fars
Postal code
7177846939
Phone
+98 71 3820 0533
Email
akrami_e@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of ethical considerations
Study Protocol
No - There is not 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