Protocol summary

Summary
 The goal of this study is to evaluate the efficacy of ginger syrup (G-rup) in the treatment of knee osteoarthritis. Inclusion criteria include moderate to severe knee pain due to osteoarthritis, and 40 to 85 years of age. Diabetes mellitus, and renal and hepatic diseases are among the exclusion criteria. In a double-blind randomized clinical trial, 42 patients with knee osteoarthritis presenting to pain clinic of Amir Alam and Shariati hospitals, Tehran, will be assigned into 2 groups. One group will receive 10 ml of G-rup syrup (ginger syrup containing 100 mg/ml ginger extract and 150 mg/ml honey extract) 3 times a day, and the other group (as control) will receive 10 ml of placebo syrup (containing 150 mg/ml honey extract, sorbitol, and ginger essence) 3 times per day for 12 weeks. All the patients will be allowed to continue their previously prescribed medications (calcium, vitamin D and benzodiazepines) as recommended by their physicians. The non-steroidal anti-inflammatory drugs shall be discontinued from one week before until the end of the study, but if the patients need analgesic medications they will be able to use acetaminophen (at maximum daily dose of 3 g). The patients’ pain and functional capacity score will be assessed by Numerical Rating Scale (NRS 0-10) and The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the beginning of the study and at 4, 8, and 12 weeks thereafter.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091924083N1
Registration date: 2016-01-22, 1394/11/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-22, 1394/11/02
Registrant information
Name
Alireza Khajehnasiri
Name of organization / entity
Shariati Hospital/Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0000
Email address
khajehnasiri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Pharmaceutical Sciences University
Expected recruitment start date
2015-10-10, 1394/07/18
Expected recruitment end date
2015-12-30, 1394/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
analgesic and anti-inflammatory effect of syrup g-rup (ginger and honey) in knee osteoarthritis
Public title
analgesic and anti-inflammatory effect of syrup g-rup (ginger and honey) in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: moderate to severe knee pain due to osteoarthritis , aged 40-85 years Exclusion criteria: Diabetes mellitus, renal and hepatic diseases, coagulation disorders, mental and psychological disorders, and intolerance or allergy to any of components of the two syrups
Age
From 40 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Islamic Azad University, Pharmaceutical Sciences Branch
Street address
No 99, Yasaman Street, Shariati Street
City
Tehran
Postal code
Approval date
2015-09-22, 1394/06/31
Ethics committee reference number
IR.IAU.PS.REC.1394.28

Health conditions studied

1

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

Primary outcomes

1

Description
Pain
Timepoint
at the beginning of the study and at 4, 8, and 12 weeks thereafter
Method of measurement
Numerical Rating Scale (NRS 0-10)

Secondary outcomes

1

Description
functional capacity
Timepoint
at the beginning of the study and at 4, 8, and 12 weeks thereafter
Method of measurement
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Intervention groups

1

Description
Intervention with placebo syrup (containing 150 mg/ml honey extract, sorbitol, and ginger essence) 10 ml, 3 times per day for 12 weeks
Category
Treatment - Drugs

2

Description
Intervention with medication: 10 ml of G-rup syrup (ginger syrup containing 100 mg/ml ginger extract and 150 mg/ml honey extract) 3 times a day for 12 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralam Hospital and Shariati Hospital
Full name of responsible person
Dr. Alireza Khajehnasiri
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Tehran Medical Sciences
Full name of responsible person
Dr.Gholamreza Amin
Street address
Tehran University Of Medical Sciences, 16 Azar Street
City
Tehran
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 of Tehran 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
Tehran University Of Medical Sciences
Full name of responsible person
Dr.Alireza Khajehnasiri
Position
Pain Fellowship/Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Shariati Hospital
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2372
Fax
Email
khajehnasiri@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Dr.Alireza Khajehnasiri
Position
Pain Fellowship/Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Shariati Hospital
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2372
Fax
Email
khajehnasiri@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Pharmaceutical Sciences Branch
Full name of responsible person
Shima Afshar
Position
Pharmacy Student
Other areas of specialty/work
Street address
No99, Yasaman Street. Shariati Street
City
Tehran
Postal code
Phone
00
Fax
Email
afshar.shiima@gmail.com
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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