Protocol summary

Summary
Goals: Osteoarthritis (OA) is a progressive, degenerative joint disease that has a major impact on joint function and quality of life. Green tea has been being used in traditional medicine and there are some evidences that this herb, especially one of its derivatives, epigllocatechin 3-gallate (EGCG), may have a role in inflammation and joint destruction. As there is no clinical study regarding the effects of either green tea or EGCG on OA, in this study we assumed to review its clinical effects in patients suffering OA. Design: An Interventional study Participants: Forty patients were enrolled into this randomized clinical trial. They were divided into two groups, cases and controls. Inclusion criteria: patients of both sexes with mild to moderate osteoarthritis of the knee, in the age group 40 to 75 years, referred to the Physical Medicine and Rehabilitation, Shiraz, Iran. Exclusion criteria: patients with severe osteoarthritis; patients suffering ischemic heart disease or heart failure; patients with renal function impairment; patients with hepatic failure; pregnant women; breastfeeding women; women who stop contraception techniques to become pregnant; patients who had a history of sensitivity to caffeine; patients whose diets are effective for weight loss or gain, and planned to decrease or increase their weight; patients who have recently begun the exercise to protect joints or changing their activity levels; patients treated with alkaline agents, for any reason, who was not able to discontinue their medications; patients treated with warfarin for any reason, that the patient was unable to stop his warfarin; patients with a history of gastrointestinal bleeding with non-steroidal anti-inflammatory drugs; patients who for any reason were not able to express their pain (eg patients with mental retardation or patients with Alzheimer's); patients who did not receive the necessary support for their drugs or they are not likely to be followed (eg, patients who were residents of older people centers ); patients who do not continure the trial: intolerable side effects for the patient (Gastrointestinal side effects such as increased gastric acid secretion, diarrhea or constipation, headache, palpitations, insomnia, irritability, restlessness);discontinuation of drugs consumption for any reason and not to follow treatment for any reason. Intervention: At the beginning of the study, WOMAC questionnaire were completed for each patient. Then, cases received 1500 mg/day of green tea leaves plus 100 mg/day diclofenac, while the controls consumed only 100 mg/day diclofenac. Outcome : After one month, they were evaluated again, using the WOMAC questionnaire. Key word: Osteoarthritis, Green tea, Epigllocatechin 3-gallate

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201307188300N2
Registration date: 2013-11-05, 1392/08/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-11-05, 1392/08/14
Registrant information
Name
Alireza Ashraf
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 9040
Email address
ashrafa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science- School of Medicine
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of green tea extracts in patients with mild to moderate knee osteoarthritis
Public title
Evaluation of the effect of green tea extracts in osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients of both sexes with mild to moderate osteoarthritis of the knee, in the age group 40 to 75 years, referred to the Physical Medicine and Rehabilitation, Shiraz, Iran. Exclusion criteria: patients with severe osteoarthritis; patients suffering ischemic heart disease or heart failure; patients with renal function impairment; patients with hepatic failure; pregnant women; breastfeeding women; women who stop contraception techniques to become pregnant; patients who had a history of sensitivity to caffeine; patients whose diets are effective for weight loss or gain, and planned to decrease or increase their weight; patients who have recently begun the exercise to protect joints or changing their activity levels; patients treated with alkaline agents, for any reason, who was not able to discontinue their medications; patients treated with warfarin for any reason, that the patient was unable to stop his warfarin; patients with a history of gastrointestinal bleeding with non-steroidal anti-inflammatory drugs; patients who for any reason were not able to express their pain (eg patients with mental retardation or patients with Alzheimer's); patients who did not receive the necessary support for their drugs or they are not likely to be followed (eg, patients who were residents of older people centers ); patients who do not continure the trial: intolerable side effects for the patient (Gastrointestinal side effects such as increased gastric acid secretion, diarrhea or constipation, headache, palpitations, insomnia, irritability, restlessness);discontinuation of drugs consumption for any reason and not to follow treatment for any reason.
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz university of medical science
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
3271

Health conditions studied

1

Description of health condition studied
Osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral

Primary outcomes

1

Description
Function
Timepoint
at the beginning and 1 month after intervention
Method of measurement
WOMAC quastionaire

2

Description
Pain
Timepoint
at the beginning and 1 month after intervention
Method of measurement
WOMAC quastionaire

3

Description
Joint stiffness
Timepoint
at the beginning and 1 month after intervention
Method of measurement
WOMAC quastionaire

Secondary outcomes

empty

Intervention groups

1

Description
cases received 1500 mg/day of green tea leaves in 3 doses(Dineh Company with certification number:1228144011) plus 100 mg/day diclofenac
Category
Treatment - Drugs

2

Description
control group: 100 mg Diclofenac
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Clinic
Full name of responsible person
Dr Alireza Ashraf
Street address
Namazi Square
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.gholamreza Hatam
Street address
Imam Hossein square
City
Shiraz
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Sadrneshin
Position
Medical Student
Other areas of specialty/work
Street address
School of Medicine
City
Shiraz
Postal code
Phone
+98 71 1234 1979
Fax
Email
sarah_sadrneshin@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Alireza Ashraf
Position
Specialist in Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences - Department of Physical Medicine and Rehabilitation
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
alirezaashraf@yahoo.com; sadrneshin@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr.Alireza Ashraf
Position
Associate Professor
Other areas of specialty/work
Street address
Faghihi hospital,Zand avenue
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
ashrafa@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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