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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05398874
• Other study ID #: MEC-13
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2022
• Source: Kufa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Combination Product:
• Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR)
120 mg leaf extract , twice daily in addition to Diclofenac 100 mg Once daily + paracetamol 1g Twice daily
• placebo in addition to the standard treatment
placebo in addition to the standard treatment

Locations

Country	Name	City	State
Iraq	Private Clinic	Najaf	N/A (Outside Of US)

Sponsors (1)

Lead Sponsor	Collaborator
Kufa University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Changes occured : baseline , 2 weeks , 4 weeks ,and 8 weeks
Secondary	IL-6	Serum level of interleukin 6	Changes occured: baseline , 4 weeks,and 8 weeks
Secondary	TNF-alpha	Serum level of tumour necrosis factor - alpha	Changes occured: baseline , 4 weeks,and 8 weeks
Secondary	urinary CTX-II	C-terminal telopeptide of type II collagen from urine samples	Changes occured :baseline , 4 weeks,and 8 weeks