Knee OsteoarthritisNCT05398874
Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis
A study testing Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR) in people with Knee Osteoarthritis, run by Kufa University at 1 site in Iraq.
Trial summary
To assess the efficacy and safety of the Ginkgo biloba extract in patients with Knee OA. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 1 Nov 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients 40-75 years old with knee OA.
- Grade II and Grade III according to the Kellgrenn-Lawrence (KL) grading system of radiographic OA.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To assess the efficacy and safety of the Ginkgo biloba extract in patients with Knee OA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR), placebo in addition to the standard treatment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR)Combination product
Also called Ginko Natrol company + Dolipran+Olfen 100 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 treatmentCombination product
placebo in addition to the standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Ginkgo + standard | Active comparator | the patients received Ginkgo biloba extract in addition to standard treatment Receives: 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 Receives: Combination Product: placebo in addition to the standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Changes occured : baseline , 2 weeks , 4 weeks ,and 8 weeks
Secondary outcomes (3)
IL-6
Serum level of interleukin 6
Measured: Changes occured: baseline , 4 weeks,and 8 weeks
TNF-alpha
Serum level of tumour necrosis factor - alpha
Measured: Changes occured: baseline , 4 weeks,and 8 weeks
urinary CTX-II
C-terminal telopeptide of type II collagen from urine samples
Measured: Changes occured :baseline , 4 weeks,and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Nov 2021
- Primary completion1 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kufa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Al-Haddad, Kufa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398874
- Sponsor's protocol ID
- MEC-13
- Status last verified
- Sep 2022
- First submitted
- 20 May 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05398874
- Acronym / sponsor ID
- MEC-13
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kufa UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy and safety of the Ginkgo biloba extract in patients with Knee OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginkgo + standard | Active comparator | Combination Product: Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR)the patients received Ginkgo biloba extract in addition to standard treatment |
| placebo + standard | Placebo comparator | Combination Product: placebo in addition to the standard treatmentthe patients received a placebo in addition to the standard treatment |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients 40-75 years old with knee OA.
- Grade II and Grade III according to the Kellgrenn-Lawrence (KL) grading system of radiographic OA.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR)Also: Ginko Natrol company + Dolipran+Olfen 100 SR120 mg leaf extract , twice daily in addition to Diclofenac 100 mg Once daily + paracetamol 1g Twice daily | Combination product | Ginkgo + standard |
| placebo in addition to the standard treatmentplacebo in addition to the standard treatment | Combination product | placebo + standard |
Primary outcome
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).
3 secondary outcomes
IL-6
Time frame: Changes occured: baseline , 4 weeks,and 8 weeks
TNF-alpha
Time frame: Changes occured: baseline , 4 weeks,and 8 weeks
urinary CTX-II
Time frame: Changes occured :baseline , 4 weeks,and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR) in people with Knee Osteoarthritis, run by Kufa University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS score (time frame: Changes occured : baseline , 2 weeks , 4 weeks ,and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.