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Evaluation of Efficacy of "Squill Oxymel " in Treatment of Knee Osteoarthritis Compared with placebo.

Protocol summary

Summary
The aim of this study is to evaluate of therapeutic efficacy of traditional medicine product "Squill Oxymel" in patients with knee osteoarthritis . First, patients with osteoarthritis of the knee, according to the criteria approved by orthopedic specialist are recruited. Then the patients are informed about the project and presence of case and control groups and after obtaining the consent; they can be enrolled into the project. Then the selected patients based on clinical and radiological osteoarthritis ACR criteria are divided into the two treatment and placebo groups. The patients are randomized into the study groups and receive encoded drug (drug or placebo) to consume according to the instructions. Patient and physician have no information about the glass content(by double-blind randomized clinical trial). Considering the inclusion criteria and after filling the form and questionnaire by the patient, the patient will be given one week period as wash out of drug. X-rays of the knee is requested (if there is no x-ray in the past 6 months) along with the necessary tests to find patients with severe kidney or liver problems for exclusion criteria, such as BUN, CR, AST, ALT. Inflammatory tests, such as WBC, ESR, CRP and Specialized tests, such as IL6, SOD are measured as basic tests for patients. During this period, patients can use up to 4g / day of acetaminophen. The syrup will be used by dosage of two tablespoons every morning fasting with a glass of water for 2 months.The patients will be visited at weeks 0, 4 and 8 and at the end of the trial; the specialized tests(IL6, SOD) and inflammatory tests(WBC, ESR, CRP) are measured to compare the two groups. One month after the end of treatment, at week 12, clinical symptoms are reevaluated and the questionnaires and forms are filled again as the follow up to the treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015101124474N1
Registration date: 2015-11-26, 1394/09/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-26, 1394/09/05
Registrant information
Name
Mojtaba Taheri
Name of organization / entity
College of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 2521
Email address
taheri.dr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
1. Traditional Medicine and Materia Medica Research Center(TMRC), Shahid Beheshti University of Medical Sciences(Tehran - Iran) 2. Barij Essence Pharmaceutical Co(Kashan - Iran)
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Efficacy of "Squill Oxymel " in Treatment of Knee Osteoarthritis Compared with placebo.
Public title
Effect of Squill Oxymel in Treatment of Knee Arthrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age 40 to 80 years old that fill clinical and radiological criteria of ACR. after drug wash out,with VAS>40mm. clinical and radiological criteria of ACR: knee pain + osteophite in radiography + at least 1 of 3 below criteria: age up 50 years old; morning stiffness less than 30 minutes; crepitation of knee. Exclusion Criteria: history of rheumatoid arthritis and gout; history of knee surgery; patients with severe cardiovascular disease, including heart failure, advanced Class 3 and 4, sick sinus syndrome (SSS), 3rd degree atrioventricular block, Wolff Parkinson's White syndrome (WPW), ventricular tachycardia (VT), hypertrophic cardiomyopathy, aortic thoracic aneurysm; proven malignancies; GI bleeding(stomach bleeding); severe liver disease(esophageal varices and bleeding, encephalopathy, ascites); patients with Symptomatic gallstone(in history); severe renal disease(creatinine greater than 3mg / dl); joint injection of corticosteroids in the past three months; received oral corticosteroids in the past 4 weeks; oral or injectable NSAID in last seven days; received chondrotin sulfate or glucosamine, warfarin, clopidogrel, digitalis, capsaicin, quinidine, laxatives or any other drugs, according to pharmacologists opinion; pregnancy and Breast-feeding. Exit criteria during study: Not wanting to continue taking the drug by the patient for any reason; Allergy symptoms or complications to acetaminophen or squill oxymel; Any clinical condition that need to change a patient's treatment regimen.
Age
From 40 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
N/A
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 in Biomedical Research, Shahid Beheshti University of Medical Sciences (IR.SBMU.REC
Street address
Office of Research Management, Shahid Beheshti University of Medical Sciences, side of Taleghani Hospital, Evin, Shahid Chamran Highway, Tehran
City
Tehran
Postal code
Approval date
2015-10-18, 1394/07/26
Ethics committee reference number
IR.SBMU.RAM.REC.1394.285

Health conditions studied

1

Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis

Primary outcomes

1

Description
pain
Timepoint
At the beginning of intervention and after 1 month, 2 months and 3 months after the beginning of intervention
Method of measurement
KOOS Pain and VAS

2

Description
Knee discomfort
Timepoint
At the beginning of intervention and after 1 month, 2 months and 3 months after the beginning of intervention
Method of measurement
KOOS Scoring

3

Description
Stiffness
Timepoint
At the beginning of intervention and after 1 month, 2 months and 3 months after the beginning of intervention
Method of measurement
KOOS Scoring

4

Description
Activites and daily living
Timepoint
At the beginning of intervention and after 1 month, 2 months and 3 months after the beginning of intervention
Method of measurement
KOOS Scoring

5

Description
Sport and recreation function
Timepoint
At the beginning of intervention and after 1 month, 2 months and 3 months after the beginning of intervention
Method of measurement
KOOS Scoring

6

Description
Quality of life
Timepoint
At the beginning of intervention and after 1 month, 2 months and 3 months after the beginning of intervention
Method of measurement
KOOS Scoring and SF26 WHO

Secondary outcomes

1

Description
SOD
Timepoint
At the beginning of intervention and 2 months later at the end of intervention
Method of measurement
Based on Lab data

2

Description
IL6
Timepoint
At the beginning of intervention and 2 months later at the end of intervention
Method of measurement
Based on Lab data

3

Description
CRP
Timepoint
At the beginning of intervention and 2 months later at the end of intervention
Method of measurement
Based on Lab data

4

Description
ESR
Timepoint
At the beginning of intervention and 2 months later at the end of intervention
Method of measurement
Based on Lab data

5

Description
WBC
Timepoint
At the beginning of intervention and 2 months later at the end of intervention
Method of measurement
Based on Lab data

Intervention groups

1

Description
Intervention group: Syrup of Squill Oxymel, 2 tablespoons in the morninig on empty stomach with a glass of lukewarm water for 8 weeks + Tablet of Acetaminophen up to 4 gr daily for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group: Placebo Syrup made from brown sugar, 2 tablespoons in the morning on empty stomach with a glass of lukewarm water for 8 weeks + Tablet of Acetaminophen up to 4 gr daily for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Shariat Panahi Clinic
Full name of responsible person
Mohammad Kazem Emami meybodi
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
Orthopedic Clinic of Bagheiyatallah Hospital
Full name of responsible person
Mojtaba Taheri
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Traditional Medicine College of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mahmood Mosadegh
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Traditional Medicine College of Shahid Beheshti 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
College of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojtaba Taheri
Position
Ph.D student of Traditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 2521
Fax
Email
taheri.dr@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
College of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roshanak Mokaberinegad
Position
Associate Professor
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 2521
Fax
Email
mokaberi@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
College of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojtaba Taheri
Position
Ph.D student ofTraditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
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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