Protocol summary
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Study aim
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Determination of the effects of Jadwar capsul on clinical manifestations of knee Osteoarthritis versus placebo
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Design
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Randomized controlled clinical trial with a parallel group design of 94 patient.phase 3.
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Settings and conduct
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Study will be performed in Tabriz Shohada hospital.Participants will be placed on intervention and control groups according block disign randomization method, after obtaining the informed consent and they will receive the drug or placebo for four weeks and thay will be under observation through this period.The study will be double-blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age 40 to 70 ; Mild to moderate knee Ostoarthritis patients according to Kellegren-Lawrence (K-L) grading scale ; Minimum annoying pain (at least 4 ) in last week before random allocation, according to VAS scale ; Pain at least in one knee in last 3 month ago. Exclusion criteria: Allergy to jadwar capsul ; Secondary osteoarthritis ; Joint transplantation ; Oral or topical use of steroids ; Pregnancy & lactation ; Addiction ; Radiculopathy or Neuropathy ; Surgery ; Trauma
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Intervention groups
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The intervention group received 500 mg jadwar capsules twice a day for four weeks each day.The control group received placebo capsules twice a day for four weeks. Pelacebo and jadwar Capsules are Produced in the shafanegar nazary pharmaceutical company.
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Main outcome variables
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1. Knee pain score according to Visual Analogue Scale and West Ontario McMaster universities questionaire 2. Daily activity score according to Visual Analogue Scale and West Ontario Mc master universities questionaire
General information
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Reason for update
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Updating the start and end date of patient recruitment has been accomplished
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181218042037N1
Registration date:
2019-06-13, 1398/03/23
Registration timing:
prospective
Last update:
2020-06-12, 1399/03/23
Update count:
1
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Registration date
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2019-06-13, 1398/03/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-06-15, 1398/03/25
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Expected recruitment end date
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2019-09-23, 1398/07/01
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Actual recruitment start date
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2019-06-15, 1398/03/25
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Actual recruitment end date
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2019-12-16, 1398/09/25
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Trial completion date
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2020-01-15, 1398/10/25
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Scientific title
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Assessment of the effect of jadwar capsule (delphinium denudatum) on clinical manifestation of knee Osteoartheritis versus Placebo : A double blind randomized controlled clinical trial.
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Public title
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Assessment of jadwar capsule on clinical manifestation of knee Osteoarthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Mild to moderate knee Ostoarthritis patients according to Kellegren-Lawrence (K-L) grading scale
Pain at least in one knee in last 3 month ago
Minimum annoying pain (at least 4 ) before randomized selection according to VAS scale
Exclusion criteria:
Allergy to oral consumption of jadwar capsul.
Secondary Osteoarthritis as Rhuomatoid arthritis,Gout,Infectious arthritis,Metabolic arthritis,Traumatic arthritis.
Operative knee joint replacement .
Topical or systemic steroid use since 14 day before study .
Intraarticular steroid injection since 90 day before study .
Pregnancy and lactation period .
Alcohol and opioid addiction
Radiculopathy and Neuropathy .
History of any kind of knee operation and trauma
Utilization of other analgesic drugs since study period
History of renal failure or heart failure or hepatic failure
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Age
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From 40 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
94
Actual sample size reached:
94
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block design randomization as individual by
Random number table
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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participantِ
clinical care providerِ
researcher
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-03-12, 1397/12/21
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Ethics committee reference number
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IR.TBZMED.REC.1397.1054
Health conditions studied
1
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Description of health condition studied
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knee osteoarthritis
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ICD-10 code
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M17
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ICD-10 code description
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Osteoarthritis of knee
Primary outcomes
1
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Description
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Score of knee pain intensity
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Timepoint
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Measuring the Score of knee pain intensity at the beginning of the study and 14 and 28 days after starting use of jadwar capsul.
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Method of measurement
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Visual Analogue Scale
2
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Description
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Daily activity Score
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Timepoint
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Measuring of Daily activity Score at the beginning of the study and 14 and 28 days after starting use of jadwar capsul.
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Method of measurement
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Western Ontario and McMaster Universities Osteoarthritis questionnaire
Intervention groups
1
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Description
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Intervention group: In this group participants receive 500 m/g of jadwar capsul in the morning and at night for 4 weeks. jadwar Capsules are Produced in the shafanegar nazary pharmaceutical company.
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Category
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Treatment - Drugs
2
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Description
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Control group: In this group participants receive 2 placebo capsules containing starch in the morning and at night for 4 weeks. pelacebo Capsules will be Produced in the shefanegar nazary pharmaceutical company.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The whole potential data after being unidentifiable is shareable
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When the data will become available and for how long
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Start the access period 4 months after printing the article
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To whom data/document is available
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Researchers working in academic, scientific and industrial institutions
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Under which criteria data/document could be used
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Additional conditions are not required.
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From where data/document is obtainable
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Rogayeh Babhervandnavid
email baghervandnavd@tbzmed.ac.ir
09144082551
rbaghervand@hotmail.com
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What processes are involved for a request to access data/document
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The requested files are submitted to the requestor about a week after receipt.
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Comments
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