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OpenTrials
Completed

NCT Number: NCT05398874

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

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Clinic

Najaf, N/A (Outside of US), 00964, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR)

Combination Product

120 mg leaf extract , twice daily in addition to Diclofenac 100 mg Once daily + paracetamol 1g Twice daily

Other names: Ginko Natrol company + Dolipran+Olfen 100 SR

placebo in addition to the standard treatment

Combination Product

placebo in addition to the standard treatment

Primary outcomes

  1. KOOS score

    Time frame: 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 outcomes

  1. IL-6

    Time frame: Changes occured: baseline , 4 weeks,and 8 weeks

    Serum level of interleukin 6

  2. TNF-alpha

    Time frame: Changes occured: baseline , 4 weeks,and 8 weeks

    Serum level of tumour necrosis factor - alpha

  3. urinary CTX-II

    Time frame: Changes occured :baseline , 4 weeks,and 8 weeks

    C-terminal telopeptide of type II collagen from urine samples

Sponsors and collaborators

Lead sponsor

Kufa University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2022
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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