NCT05398874

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 2, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

May 20, 2022

Last Update Submit

September 1, 2022

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • IL-6

    Changes occured: baseline , 4 weeks,and 8 weeks

  • TNF-alpha

    Changes occured: baseline , 4 weeks,and 8 weeks

  • urinary CTX-II

    Changes occured :baseline , 4 weeks,and 8 weeks

Study Arms (2)

Ginkgo + standard

ACTIVE COMPARATOR

the patients received Ginkgo biloba extract in addition to standard treatment

Combination Product: Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR)

placebo + standard

PLACEBO COMPARATOR

the patients received a placebo in addition to the standard treatment

Combination Product: placebo in addition to the standard treatment

Interventions

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

Also known as: Ginko Natrol company + Dolipran+Olfen 100 SR
Ginkgo + standard
placebo in addition to the standard treatmentCOMBINATION_PRODUCT

placebo in addition to the standard treatment

placebo + standard

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients 40-75 years old with knee OA.
  • Grade II and Grade III according to the Kellgrenn-Lawrence (KL) grading system of radiographic OA.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Clinic

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

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ginkgo biloba extract

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 20, 2022

First Posted

June 1, 2022

Study Start

November 1, 2021

Primary Completion

June 1, 2022

Study Completion

August 1, 2022

Last Updated

September 2, 2022

Record last verified: 2022-09

Locations

IR(1)