Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Combination Product: Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR); Combination Product: placebo in addition to the standard treatment

• Registration Number: NCT05398874
• Lead Sponsor: Kufa University

Brief Summary

To assess the efficacy and safety of the Ginkgo biloba extract in patients with Knee OA.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-31
• Primary Completion: 2022-06-01
• Study First Posted: 2022-06-01
• Study Completion: 2022-08-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginkgo + standard	Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR)	the patients received Ginkgo biloba extract in addition to standard treatment
placebo + standard	placebo in addition to the standard treatment	the patients received a placebo in addition to the standard treatment

Primary Outcome Measures

Name	Time	Method
KOOS score	Changes occured : baseline , 2 weeks , 4 weeks ,and 8 weeks	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

Name	Time	Method
IL-6	Changes occured: baseline , 4 weeks,and 8 weeks	Serum level of interleukin 6
TNF-alpha	Changes occured: baseline , 4 weeks,and 8 weeks	Serum level of tumour necrosis factor - alpha
urinary CTX-II	Changes occured :baseline , 4 weeks,and 8 weeks	C-terminal telopeptide of type II collagen from urine samples

Trial Locations

Locations (1)

Private Clinic; 🇮🇶 Najaf, N/A (Outside Of US), Iraq