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Clinical 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
Kufa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 20, 2022
Last Updated
September 1, 2022
Sponsor
Kufa University
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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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