Fumaria parviflora L.and terminalia chebula Retz for treatment of post burn pruritus
Design
a double-blind, randomized controlled clinical trial with the parallel-groups design of 45 patients with Balance blocked randomization method
Settings and conduct
Burned patients with uncontrolled pruritus that come to Amir_Almomenin clinic placed in A, B or C group according randomization table. Only pharmacist knows which one is case or control group. At first, questioner fills questionnaire and detect the severity o pruritus according VAS (visual analog scale). drugs are taken to patient for two weeks. after 2 weeks, severity o pruritus is evaluated and
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-patients with post burn pruritus
2-over 18 years old
3-VAS>=4
Exclusion criteria:
1-not having liver disease, kidney disease, respiratory disease, metabolic disease, hypertension, convulsion or skin diseases that lead to pruritus
2-not having a hemolytic disease
Intervention groups
Patients are placed in 3 groups. The groups take Fumaria parviflora L. or the combination of Fumaria parviflora L.and terminalia chebula Retz or flour.
Main outcome variables
severity of pruritus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180609040016N2
Registration date:2020-10-07, 1399/07/16
Registration timing:registered_while_recruiting
Last update:2020-10-07, 1399/07/16
Update count:0
Registration date
2020-10-07, 1399/07/16
Registrant information
Name
Abdolkhalegh Keshavarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3614 6521
Email address
keshavarzg@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Fumaria Parviflora L. on post burn pruritus: A randomized double- blind clinical trial
Public title
Evaluation the effect of Fumaria Parviflora L. on post burn pruritus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with post burn pruritus
over 18 years old
Visual Analogue Scale>=4
Exclusion criteria:
not having liver disease, kidney disease, respiratory disease, metabolic disease, hypertension, convulsion, skin diseases that lead to pruritus
not having hemolytic disease
Age
From 18 years old
Gender
Both
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:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done according blocked randomization with three groups in each block and the block's arrangement is randomly according to Random number table And the allocation of treatment for patients is based on the final order of the blocks and the order of the groups within each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Only pharmacist knows which one is control and which one is placebo. they are packed in A, B, C. Then each patients is placed in one group according randomization table.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2019-10-26, 1398/08/04
Ethics committee reference number
IR.SUMS.REC.1398.962
Health conditions studied
1
Description of health condition studied
1. Evaluation the effect of Fumaria Parviflora L. on post burn prurits. 2.Evaluation the effect of combination of Fumaria Parviflora L. and Terminalia Chebula Retz on post burn prurits.
ICD-10 code
L29.8
ICD-10 code description
Other pruritus
Primary outcomes
1
Description
the severity of post burn pruritus
Timepoint
every two weeks
Method of measurement
Visual Analogue Scale that 0 means no itching and 10 means the most severe of itching
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Fumaria Parviflora capsule produced by Shiraz School of Pharmacy, administer two capsules before breakfast, lunch and dinner (300 mg Fmaria Parviflora powder in each capsule) for 4 weeks.
Category
Treatment - Drugs
2
Description
Intervention: Fumaria Parviflora and Terminalia Chebula Retz capsule produced by Shiraz School of Pharmacy, administer two capsules before breakfast, lunch and dinner (300 mg Fmaria Parviflora powder in each capsule) for 4 weeks. group:
Category
Treatment - Drugs
3
Description
Control group: Placebo capsule produced by Shiraz School of Pharmacy, administer two capsules before breakfast, lunch and dinner for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Abdolkhalegh Keshavarzi
Street address
Sadra Blvd.
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3622 4315
Fax
+98 71 3622 0437
Email
rahimeh.akrami@yahoo.com
Web page address
https://amiralmomeninbh.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abbas Rezaian-zadeh
Street address
Zand street
City
shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3230 5410
Email
rahimeh.akrami@yahoo.com
Web page address
https://research.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Rahimeh Akrami
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sadra city, Amir Al-Momenin Hospital
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3622 4315
Fax
Email
rahimeh.akrami@yahoo.com
Web page address
https://amiralmomeninbh.sums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abdolkhalegh Keshavarzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Amir-Almomenin hospital, Sadra city
City
shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3614 6100
Email
Keshavarzg@sums.ac.ir
Web page address
https://amiralmomeninbh.sums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Rahimeh Akrami
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Amir-Almomenin hospital, Sadra city
City
shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3614 6100
Email
rahimeh.akrami@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
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
primary outcome measure
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
for research
From where data/document is obtainable
rahimeh.akrami@yahoo.com
What processes are involved for a request to access data/document