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The effects of licorice supplementation on clinical symptoms and inflammatory markers in patients with active rheumatoid arthritis

Protocol summary

Study aim
Determining the effect of licorice supplementation on clinical symptoms and inflammatory markers in patients with active rheumatoid arthritis
Design
Intervention group: Rheumatoid arthritis patients who received capsules containing 0.5 mg of licorice prepared by Iran Daruk Company 3 times a day for 8 weeks. Control group: Rheumatoid arthritis patients receiving capsules containing placebo, prepared by Iran Daruk Company, receive orally 3 times a day for 8 weeks. by statistical consultant and by software
Settings and conduct
The upcoming research plan will be a simple randomized allocation and double-blind clinical trial that will be conducted on known rheumatoid arthritis patients under the treatment of a specialist doctor at the Sirjan Faculty of Medical Sciences clinic. Patients will participate in this project after obtaining written informed consent and meeting the inclusion criteria.
Participants/Inclusion and exclusion criteria
The study inclusion criteria include patients with rheumatoid arthritis aged between 20 and 70 years. Also, the exclusion criteria will include the following: heart, kidney or hypertension patients, history of heart attack, high blood lipids, abnormal kidney or liver function, use of non-steroidal anti-inflammatory drugs, use of vitamins and/or supplements minerals and drugs such as thyroid hormones, antihypertensive drugs, contraceptives, diuretics and beta blockers
Intervention groups
Intervention group: Rheumatoid arthritis patients who received capsules containing 0.5 mg of licorice prepared by Iran Daruk Company 3 times a day for 8 weeks. Control group: Rheumatoid arthritis patients receiving capsules containing placebo, prepared by Iran Daruk Company, receive orally 3 times a day for 8 weeks.
Main outcome variables
Disease activity score 28

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221127056629N1
Registration date: 2022-12-18, 1401/09/27
Registration timing: prospective

Last update: 2022-12-18, 1401/09/27
Update count: 0
Registration date
2022-12-18, 1401/09/27
Registrant information
Name
Mohammad amin Serpoosh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4223 2052
Email address
ma.serpoosh@sirums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of licorice supplementation on clinical symptoms and inflammatory markers in patients with active rheumatoid arthritis
Public title
The effect of licorice administration on patients with rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with joint rheumatism referring to Sirjan Faculty of Medical Sciences clinic Filling the consent form by patients
Exclusion criteria:
Heart, kidney or hypertension patients, history of heart attack, high blood lipids, abnormal kidney or liver function, use of non-steroidal anti-inflammatory drugs, use of vitamins and/or mineral supplements and drugs such as thyroid hormones, anti-hypertensive drugs Blood, contraceptives, diuretics and beta-blockers, as well as alcohol consumption, smoking, pregnancy and breastfeeding Other underlying diseases and also it should be mentioned that each person participating in the study will be excluded from the study in case of discontinuation of treatment or side effects caused by the consumption of licorice.
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups of intervention (38 patients) and placebo (38 patients). Supplement and placebo will be placed in similar containers by someone outside the study based on the corresponding codes written on the containers. Supplement or placebo recipients will be assigned based on entry code. In this double-blind study, the factors that can distort the results of the experiment, such as information about receiving a supplement or placebo, will remain hidden from both the participants (patients) and the researcher.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplement and placebo will be placed in similar containers by someone outside the study based on the corresponding codes written on the containers. Supplement or placebo recipients will be assigned based on entry code. In this double-blind study, the factors that can distort the results of the experiment, such as information about receiving a supplement or a placebo, will remain hidden from both the participants (patients) and the researcher.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشکده علوم پزشکی سیرجان
Street address
Ibn Sina St., Sirjan school of Medical Sciences
City
sirjan
Province
Kerman
Postal code
7816916338
Approval date
2022-11-19, 1401/08/28
Ethics committee reference number
IR.SIRUMS.REC.1401.012

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor

Primary outcomes

1

Description
Disease severity
Timepoint
0،90
Method of measurement
Disease activity score 28 ( DAS28)

Secondary outcomes

1

Description
Erythrocyte sedهmentation rate
Timepoint
0،90
Method of measurement
Westergren method

2

Description
intensity of pain
Timepoint
0،90
Method of measurement
The patients will be asked to mark their pain level from their point of view on a ten-point scale.

3

Description
CRP
Timepoint
0,90
Method of measurement
Agglutination method

4

Description
TNF-α
Timepoint
0,90
Method of measurement
Eliza method

5

Description
IL-6
Timepoint
0,90
Method of measurement
Eliza method

6

Description
Systolic blood pressure
Timepoint
0,90
Method of measurement
by barometer

7

Description
diastolic blood pressure
Timepoint
0,90
Method of measurement
by barometer

8

Description
AST
Timepoint
0,90
Method of measurement
Colorimetric method and photometer

9

Description
licorice
Timepoint
0,90
Method of measurement
by scales

10

Description
potassium
Timepoint
0,90
Method of measurement
Flynn photometry method

11

Description
fasting blood sugar
Timepoint
0،90
Method of measurement
Colorimetric method and photometer

Intervention groups

1

Description
Intervention group: Rheumatoid arthritis patients who received capsules containing 0.5 mg of licorice prepared by Iran Daruk Company 3 times a day for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group: Rheumatoid arthritis patients receiving capsules containing placebo, prepared by Iran Daruk Company, receive orally 3 times a day for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
درمانگاه دانشکده علوم پزشکی سیرجان
Full name of responsible person
دکتر محمود رضا مسعودی
Street address
Ibn Sina Street - Sirjan Faculty of Medical Sciences
City
sirjan
Province
Kerman
Postal code
7816916338
Phone
+98 34 4223 4513
Email
Masoodi85@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
sirjan school of medical science
Full name of responsible person
Dr mahmood reza masoudi
Street address
خیابان ابن سینا
City
sirjan
Province
Kerman
Postal code
7816916338
Phone
+98 34 4223 4513
Email
Masoodi85@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
sirjan school of medical science
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
sirjan school of medical science
Full name of responsible person
Mohammad amin serpoosh
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
ibn sina street , sirjan school of medical sicence
City
sirjan
Province
Kerman
Postal code
7816916338
Phone
+98 34 4223 4513
Email
aminsrps@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
sirjan school of medical science
Full name of responsible person
Dr mahmood reza masoudi
Position
faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
ibn sina street sirjan school of medical science
City
sirjan
Province
Kerman
Postal code
7816916338
Phone
+98 34 4223 4513
Email
Masoodi85@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
sirjan school of medical science
Full name of responsible person
Mohammad amin serpoosh
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
ibn sina street , sirjan school of medical sicence
City
sirjan
Province
Kerman
Postal code
7816916338
Phone
+98 34 4223 4513
Email
aminsrps@gmail.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
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
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