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

September 1, 2022 updated by: Maryam Al-Haddad, Kufa University
To assess the efficacy and safety of the Ginkgo biloba extract in patients with Knee OA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • N/A (Outside Of US)
      • Najaf, N/A (Outside Of US), Iraq, 00964
        • Private Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ginkgo + standard
the patients received Ginkgo biloba extract in addition to standard treatment
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
Other Names:
  • Ginko Natrol company + Dolipran+Olfen 100 SR
Placebo Comparator: placebo + standard
the patients received a placebo in addition to the standard treatment
Combination product: placebo in addition to the standard treatment
placebo in addition to the standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Changes occured : baseline , 2 weeks , 4 weeks ,and 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kufa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

September 2, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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