Back to resultsClinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR)
placebo in addition to the standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- patients 40-75 years old with knee OA.
- Grade II and Grade III according to the Kellgrenn-Lawrence (KL) grading system of radiographic OA.
Exclusion Criteria:
- Pregnancy, breastfeeding
- Liver or renal problems
- Patient taking any drug that might interact with Ginkgo extract (eg. warfarin, etc.)
- patient with cardiovascular or cerebral vascular disorders, uncontrolled diabetes, allergic to ginkgo, recent surgery or hospital admission, >75 years old.
- Allergic or contraindicated to using NSAIDs
Sites / Locations
- Private Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ginkgo + standard
placebo + standard
Arm Description
the patients received Ginkgo biloba extract in addition to standard treatment
the patients received a placebo in addition to the standard treatment
Outcomes
Primary Outcome Measures
KOOS score
42 item questionnaire to assess pain, other symptoms, activities of daily living (ADL), sport and recreation function (Sport/Rec) and knee-related quality of life (QOL).
Secondary Outcome Measures
IL-6
Serum level of interleukin 6
TNF-alpha
Serum level of tumour necrosis factor - alpha
urinary CTX-II
C-terminal telopeptide of type II collagen from urine samples
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05398874
Brief Title
Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis
Official Title
Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kufa University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To assess the efficacy and safety of the Ginkgo biloba extract in patients with Knee OA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ginkgo + standard
Arm Type
Active Comparator
Arm Description
the patients received Ginkgo biloba extract in addition to standard treatment
Arm Title
placebo + standard
Arm Type
Placebo Comparator
Arm Description
the patients received a placebo in addition to the standard treatment
Intervention Type
Combination Product
Intervention Name(s)
Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR)
Other Intervention Name(s)
Ginko Natrol company + Dolipran+Olfen 100 SR
Intervention Description
120 mg leaf extract , twice daily in addition to Diclofenac 100 mg Once daily + paracetamol 1g Twice daily
Intervention Type
Combination Product
Intervention Name(s)
placebo in addition to the standard treatment
Intervention Description
placebo in addition to the standard treatment
Primary Outcome Measure Information:
Title
KOOS score
Description
42 item questionnaire to assess pain, other symptoms, activities of daily living (ADL), sport and recreation function (Sport/Rec) and knee-related quality of life (QOL).
Time Frame
Changes occured : baseline , 2 weeks , 4 weeks ,and 8 weeks
Secondary Outcome Measure Information:
Title
IL-6
Description
Serum level of interleukin 6
Time Frame
Changes occured: baseline , 4 weeks,and 8 weeks
Title
TNF-alpha
Description
Serum level of tumour necrosis factor - alpha
Time Frame
Changes occured: baseline , 4 weeks,and 8 weeks
Title
urinary CTX-II
Description
C-terminal telopeptide of type II collagen from urine samples
Time Frame
Changes occured :baseline , 4 weeks,and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients 40-75 years old with knee OA.
Grade II and Grade III according to the Kellgrenn-Lawrence (KL) grading system of radiographic OA.
Exclusion Criteria:
Pregnancy, breastfeeding
Liver or renal problems
Patient taking any drug that might interact with Ginkgo extract (eg. warfarin, etc.)
patient with cardiovascular or cerebral vascular disorders, uncontrolled diabetes, allergic to ginkgo, recent surgery or hospital admission, >75 years old.
Allergic or contraindicated to using NSAIDs
Facility Information:
Facility Name
Private Clinic
City
Najaf
State/Province
N/A (Outside Of US)
ZIP/Postal Code
00964
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis
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