Osteoarthritis, KneeNCT03703024
An Intervention Study Evaluating the Effects of a Raspberry Leaf Extract in an Osteoarthritic Population.
A study testing Raspberry Leaf Extract in people with Osteoarthritis, Knee, run by Atlantia Food Clinical Trials at 1 site in Ireland.
Trial summary
A double-blind, randomized, placebo-controlled clinical study to evaluate the efficacy of raspberry extract to alleviate symptoms of osteoarthritis in the knee. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Raspberry Leaf Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jun 2017to 31 Dec 2018
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be considered eligible for enrolment into the study, subjects must;
- Be aged 30 to 75 years (inclusive),
- Be willing to provide informed consent,
- Have a BMI between 18.5 and 32 kg/m2,
- Have documented diagnosis of primary osteoarthritis (OA) of the target knee made at least 12 months prior to Screening,
- Have radiographic evidence of OA in the tibio-femoral compartment of the target knee with at least 1 definite osteophyte and a measureable joint space, as diagnosed by standard X-rays taken no longer than 18 months,
- Have mild to moderate pain not adequately or completely controlled with anti-inflammatory drugs,
- Be able to perform the 20-meter walking test and to understand all questions from the WOMAC questionnaire.
Who cannot join
- Subjects will be excluded from the study if they meet any of the below criteria;
- 1. Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses), OR
- child bearing potential, the subject is eligible to enter and participate in this study if she is not lactating and has a negative urine pregnancy test at the screening visit, visit 2 and upon completion of the study at visit 5. The subject must also agree to one of the following methods of contraception: i. Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where subject discontinues the study prematurely. (Subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit.) or, ii. Has a male sexual partner who is surgically sterilized prior to the Screen Visit and is the only male sexual partner for that subject or, iii. Sexual partner(s) is/are exclusively female or, iv. Oral contraceptives (either combined or progestogen only) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm. (Women of child-bearing potential using an oral contraceptive in combination with a double-barrier method of contraception are required to continue to use this form of contraception for 1 week following discontinuation of study medication).
- Use of double-barrier contraception, specifically, a spermicide plus a mechanical barrier (e.g. male condom, female diaphragm). The subject must be using this method for at least 1 week following the end of the study or, vi. Use of any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year. The subject must have the device inserted at least 2 weeks prior to the first Screen Visit, throughout the study, and 2 weeks following the end of the study.
- Patient with secondary OA (due to a known disorder)
Show all 23Show fewer
- Has modified Kellgren-Lawrence Numerical Grading System of grade IV in the patello-femoral compartment of the target knee confirmed by standard X-rays taken no longer than 12 months prior to Screening, and before any baseline assessment,
- Has clinically apparent tense effusion of the target knee or other joint,
- Has had viscosupplementation in any joint including the target knee or other joint within 9 months prior to Screening,
- Subject is taking any anti-inflammatory steroid medications, salicylates (aspirin) or Propionic acid derivatives (ibuprofen), for 2 weeks prior to study entry,
- Has concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis and active infection, etc.),
- Symptomatic OA of the contralateral knee that is not responsive to paracetamol and requires other therapy,
- Taking any calcium supplements (4-week washout) or other supplement e.g. glucosamine, chondroitin,
- Any medical condition deemed exclusionary by the Principal Investigator/Study doctor,
- Subject has a history of drug and / or alcohol abuse at the time of enrolment,
- Change of dietary habit within the preceding month,
- Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease,
- Subject currently involved in any other clinical trial or having participated in a trial within the preceding 90 days,
- Subject with known allergy to components of the test product,
- Subject has any concurrent medical or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements,
- Subject has a history of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years,
- Subject has a significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude supplement ingestion and/or assessment of safety and the study objectives,
- Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation/severe, difficulty swallowing).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy of Raspberry Extract to Alleviate Symptoms of Osteoarthritis in the Knee
A double-blind, randomized, placebo-controlled clinical study to evaluate the efficacy of raspberry extract to alleviate symptoms of osteoarthritis in the knee.
Read the detailed description
It is estimated that up to 260 subjects will be screened.
Subjects will undergo an initial phone screen and will be asked questions regarding their age, weight, and general health. Eligible subjects will be scheduled for an initial visit. The study will involve 3 visits over a 12 to 13-week period.
At the initial screening/baseline visit (Visit 1), the inclusion and exclusion criteria will be reviewed and the overall details of the study will be explained and informed consent obtained. Demographic data, vitals (blood pressure, heart rate and temperature), anthropometric measurements (weight, height and BMI) will be recorded. Family and medical history, and concomitant medications will be recorded. For women of child bearing age, a urine sample will be collected and pregnancy test performed. A blood sample (20mls) will be collected and haematology, biochemistry, glucose and hs-CRP will be measured. Additional serum will be aliquoted and stored and inflammatory biomarkers measured at a later date.
Subjects will complete the following questionnaires: International Physical Activity Questionnaire (IPAQ), Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC), Participant global assessment short form 36 (SF-36) and pain assessment using a Visual Analogue Scale (VAS).
Subjects will undergo the Short Physical Performance Battery (SPPB) test and will complete the 20-meter walk test.
Subjects will be provided with an electronic tablet and instructed to complete daily and record daily symptoms of pain (of the target knee), compliance in relation to taking the study product and record any rescue or other medication taken during the study duration.
Subjects will be randomised to one of three treatment groups as follows:
- Arm 1 -Placebo
- Arm 2 - 200mg raspberry extract
- Arm 3 - 400mg raspberry extract
Subjects will be provided with a box containing 6-weeks supply of study product, along with an additional 4-day supply in case of loss. Subjects will be instructed to take 1 capsule each morning, with their breakfast, for the duration of the study.
Subjects will return for visits at week 6 and week 12. At each visit the vitals, anthropometric measurements, concomitant medication and any adverse events will be recorded Subjects will complete the following questionnaires: International Physical Activity Questionnaire (IPAQ), Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC), Participant global assessment short form 36 (SF-36) and pain assessment using a Visual Analogue Scale (VAS).
Subjects will undergo the Short Physical Performance Battery (SPPB) test and will complete the 20-meter walk test.
Subjects will return their electronic device and the data will be downloaded and reviewed.
Subjects will return any unused study product and compliance will be assessed and new study product administered. On Visit 3, a blood sample (20mls) will be collected and haematology, biochemistry, glucose and hs-CRP will be measured. Additional serum will be aliquoted and stored and inflammatory biomarkers measured at a later date.
Subjects will be instructed to follow their standard diet and exercise routine and not consume medications that could interfere with the assessment of the study product for the duration of the study. Any symptoms and changes in their health status or medications will be recorded.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Raspberry Leaf Extract, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raspberry Leaf ExtractDietary supplement
Eligible subjects will be scheduled for an initial visit. The study will involve 3 visits over a 12 to 13-week period. One capsule to be taken every morning over a 12-13 week period.
PlaceboDietary supplement
Also called Maltodextrin
Delivered in a capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo |
| Low dose | Active comparator | 200mg raspberry leaf extract. One capsule to be taken every morning over a 12-13 week period. Subjects will be instructed to take 1 capsule every morning with their breakfast. Receives: Dietary Supplement: Raspberry Leaf Extract |
| High dose | Active comparator | 400mg raspberry leaf extract. One capsule to be taken every morning over a 12-13 week period. Subjects will be instructed to take 1 capsule every morning with their breakfast. Receives: Dietary Supplement: Raspberry Leaf Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change, if any, in Pain Scores from baseline to the end of treatment using WOMAC
Change from baseline to study completion in pain scores on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) To assess pain, stiffness, and physical function in patients with knee osteoarthritis
The WOMAC consists of 24 items divided into 3 subscales:
- Pain (5 items)
- Stiffness (2 items)
- Physical Function (17 items)
The scale uses the following descriptors for all items: none, mild, moderate, severe, and extreme. These correspond to an ordinal scale of 0-4.
The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 12-13 weeks
Secondary outcomes (9)
Change, if any, from baseline to the end of treatment in WOMAC stiffness sub-score
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) will be used to determine stiffness score.
•Stiffness (2 items): after first waking and later in the day. The score for stiffness = 0-8. A higher score indicates stiffness.
Measured: 12-13 weeks
Change, if any, from baseline to the end of treatment in WOMAC physical function sub-score.
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) will be used to determine change in physical function from baseline to study completion.
•Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.
The possible score for Physical function ranges from 0-68. A higher score indicates bad physical function.
Measured: 12-13 weeks
Change, if any, from baseline to the end of treatment in WOMAC composite score
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) will be used to determine a composite score of the 3 subscales.
Measured: 12-13 weeks
Change, if any, in pain score using the VAS (for target knee joint & all other joints separately)
Visual Analogue Scale (VAS) features a horizontal line with the words NO PAIN on the left and WORST PAIN on the right. The subject marks the line to indicate overall pain in the previous 6 weeks. The line is then measured in mm and a higher measurement indicates greater pain.
Measured: 12-13 weeks
Change in Quality of Life scores
Participant Global Assessment using a short form survey of 36 questions can observe subjects overall quality of life.
Measured: 12-13 weeks
Change, if any, in walking speed
20 m walking test is timed at each visit and will be compared to determine if there is a change in speed throughout the duration of the study.
Measured: 12-13 weeks
Change, if any, in physical performance
Short Physical Performance Battery (SPPB) is performed at each visit and will be compared to determine if there is a change in physical performance throughout the duration of the study. The SPPB includes a balance test, gait speed test and chair stand test. All of which can indicate if there is a change from week 1 to 12.
Measured: 12-13 weeks
Change, if any, in activity levels
International Physical Activity Questionnaire (IPAQ) will be used to determine a change in activity levels throughout the duration of the study. Expressed as MET-min per week: MET level (walking, moderate/vigorous exercise) x minutes of activity/day x days per week.
Measured: 12-13 weeks
Reduction in use of medication to manage pain compared to placebo
A device is provided to each subject upon randomisation with instructions to complete a series of questions daily. These questions include frequency and amount of medication consumed on said day. This is monitored to observe the use of medication throughout the 12-13 week study duration.
Measured: 12-13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Jun 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, randomized, placebo-controlled clinical study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantia Food Clinical Trials
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof Michael Molloy, Principal investigator, Consultant Rheumatologist, Consultants Private Clinic, Cork University Hospital, Bishopstown road, Wilton, Cork.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703024
- Sponsor's protocol ID
- AFCRO-070
- Status last verified
- Oct 2018
- First submitted
- 11 Apr 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Henrotin Y, Cozannet RL, Fanca-Berthon P, Truillet R, Cohen-Solhal M, DunnGalvin G, Grouin JM, Doolan A. Rubus idaeus extract improves symptoms in knee osteoarthritis patients: results from a phase II double-blind randomized controlled trial. BMC Musculoskelet Disord. 2022 Jul 7;23(1):650. doi: 10.1186/s12891-022-05612-2.
PubMed 35799169
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy of Raspberry Extract to Alleviate Symptoms of Osteoarthritis in the Knee
- ClinicalTrials.gov ID
- NCT03703024
- Acronym / sponsor ID
- AFCRO-070
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Atlantia Food Clinical TrialsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 11 Oct 2018 (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.
A double-blind, randomized, placebo-controlled clinical study to evaluate the efficacy of raspberry extract to alleviate symptoms of osteoarthritis in the knee.
Detailed description
It is estimated that up to 260 subjects will be screened.
Subjects will undergo an initial phone screen and will be asked questions regarding their age, weight, and general health. Eligible subjects will be scheduled for an initial visit. The study will involve 3 visits over a 12 to 13-week period.
At the initial screening/baseline visit (Visit 1), the inclusion and exclusion criteria will be reviewed and the overall details of the study will be explained and informed consent obtained. Demographic data, vitals (blood pressure, heart rate and temperature), anthropometric measurements (weight, height and BMI) will be recorded. Family and medical history, and concomitant medications will be recorded. For women of child bearing age, a urine sample will be collected and pregnancy test performed. A blood sample (20mls) will be collected and haematology, biochemistry, glucose and hs-CRP will be measured. Additional serum will be aliquoted and stored and inflammatory biomarkers measured at a later date.
Subjects will complete the following questionnaires: International Physical Activity Questionnaire (IPAQ), Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC), Participant global assessment short form 36 (SF-36) and pain assessment using a Visual Analogue Scale (VAS).
Subjects will undergo the Short Physical Performance Battery (SPPB) test and will complete the 20-meter walk test.
Subjects will be provided with an electronic tablet and instructed to complete daily and record daily symptoms of pain (of the target knee), compliance in relation to taking the study product and record any rescue or other medication taken during the study duration.
Subjects will be randomised to one of three treatment groups as follows:
- Arm 1 -Placebo
- Arm 2 - 200mg raspberry extract
- Arm 3 - 400mg raspberry extract
Subjects will be provided with a box containing 6-weeks supply of study product, along with an additional 4-day supply in case of loss. Subjects will be instructed to take 1 capsule each morning, with their breakfast, for the duration of the study.
Subjects will return for visits at week 6 and week 12. At each visit the vitals, anthropometric measurements, concomitant medication and any adverse events will be recorded Subjects will complete the following questionnaires: International Physical Activity Questionnaire (IPAQ), Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC), Participant global assessment short form 36 (SF-36) and pain assessment using a Visual Analogue Scale (VAS).
Subjects will undergo the Short Physical Performance Battery (SPPB) test and will complete the 20-meter walk test.
Subjects will return their electronic device and the data will be downloaded and reviewed.
Subjects will return any unused study product and compliance will be assessed and new study product administered. On Visit 3, a blood sample (20mls) will be collected and haematology, biochemistry, glucose and hs-CRP will be measured. Additional serum will be aliquoted and stored and inflammatory biomarkers measured at a later date.
Subjects will be instructed to follow their standard diet and exercise routine and not consume medications that could interfere with the assessment of the study product for the duration of the study. Any symptoms and changes in their health status or medications will be recorded.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A double-blind, randomized, placebo-controlled clinical study.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin |
| Low dose | Active comparator | Dietary Supplement: Raspberry Leaf Extract200mg raspberry leaf extract. One capsule to be taken every morning over a 12-13 week period. Subjects will be instructed to take 1 capsule every morning with their breakfast. |
| High dose | Active comparator | Dietary Supplement: Raspberry Leaf Extract400mg raspberry leaf extract. One capsule to be taken every morning over a 12-13 week period. Subjects will be instructed to take 1 capsule every morning with their breakfast. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- To be considered eligible for enrolment into the study, subjects must;
- Be aged 30 to 75 years (inclusive),
- Be willing to provide informed consent,
- Have a BMI between 18.5 and 32 kg/m2,
- Have documented diagnosis of primary osteoarthritis (OA) of the target knee made at least 12 months prior to Screening,
Key exclusion criteria (23 listed)
- Subjects will be excluded from the study if they meet any of the below criteria;
- 1. Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses), OR
- child bearing potential, the subject is eligible to enter and participate in this study if she is not lactating and has a negative urine pregnancy test at the screening visit, visit 2 and upon completion of the study at visit 5. The subject must also agree to one of the following methods of contraception: i. Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where subject discontinues the study prematurely. (Subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit.) or, ii. Has a male sexual partner who is surgically sterilized prior to the Screen Visit and is the only male sexual partner for that subject or, iii. Sexual partner(s) is/are exclusively female or, iv. Oral contraceptives (either combined or progestogen only) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm. (Women of child-bearing potential using an oral contraceptive in combination with a double-barrier method of contraception are required to continue to use this form of contraception for 1 week following discontinuation of study medication).
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 |
|---|---|---|
| Raspberry Leaf ExtractEligible subjects will be scheduled for an initial visit. The study will involve 3 visits over a 12 to 13-week period. One capsule to be taken every morning over a 12-13 week period. | Dietary supplement | High dose, Low dose |
| PlaceboAlso: MaltodextrinDelivered in a capsule | Dietary supplement | Placebo |
Primary outcome
Change, if any, in Pain Scores from baseline to the end of treatment using WOMAC
Time frame: 12-13 weeks
Change from baseline to study completion in pain scores on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) To assess pain, stiffness, and physical function in patients with knee osteoarthritis The WOMAC consists of 24 items divided into 3 subscales: * Pain (5 items) * Stiffness (2 items) * Physical Function (17 items) The scale uses the following descriptors for all items: none, mild, moderate, severe, and extreme. These correspond to an ordinal scale of 0-4. The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
9 secondary outcomes
Change, if any, from baseline to the end of treatment in WOMAC stiffness sub-score
Time frame: 12-13 weeks
Change, if any, from baseline to the end of treatment in WOMAC physical function sub-score.
Time frame: 12-13 weeks
Change, if any, from baseline to the end of treatment in WOMAC composite score
Time frame: 12-13 weeks
Change, if any, in pain score using the VAS (for target knee joint & all other joints separately)
Time frame: 12-13 weeks
Change in Quality of Life scores
Time frame: 12-13 weeks
Change, if any, in walking speed
Time frame: 12-13 weeks
Change, if any, in physical performance
Time frame: 12-13 weeks
Change, if any, in activity levels
Time frame: 12-13 weeks
Reduction in use of medication to manage pain compared to placebo
Time frame: 12-13 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 10 Jan 2019.
- Derived from this study: PubMed 35799169Henrotin Y, Cozannet RL, Fanca-Berthon P, Truillet R, Cohen-Solhal M, DunnGalvin G, Grouin JM, Doolan A. Rubus idaeus extract improves symptoms in knee osteoarthritis patients: results from a phase II double-blind randomized controlled trial. BMC Musculoskelet Disord. 2022 Jul 7;23(1):650. doi: 10.1186/s12891-022-05612-2.
- Kim LS, Axelrod LJ, Howard P, et al. Efficacy of methylsulfonylmethane (MSM) in osteoarthritis pain of the knee: a pilot clinical trial. Osteoarthritis and Cartilage. 2006 ; 14: 286-294.Link provided by the sponsor.
- Farid R, Mirfeizi Z, Mirheidari M, et al. Pycnogenol supplementation reduces pain and stiffness and improves physical function in adults with knee osteoarthritis. Nutrition Research. 2007; 27:692-697.Link provided by the sponsor.
- Belcaro G, Cesarone MR, Dugall M, et al. Product-evaluation registry of Meriva®, a curcumin phosphatidylcholine complex, for the complementary management of osteoarthritis. Panminerva Medica The Journal of the Italian Medical Association. 2010; 52:55-62.Link provided by the sponsor.
- Parsons M, Simpson M, Ponton T. Raspberry leaf and its effect on labour: safety and efficacy. Australian College of Midwives Incorporated Journal. 1999; 12:20-5.Link provided by the sponsor.
- Simpson M, Parsons M, Greenwood J, et al. Raspberry leaf in pregnancy: its safety and efficacy in labor. Journal of Midwifery \& Women's Health. 2001; 46:51-9.Link provided by the sponsor.
- Nordeng H, Bayne K, Havnen GC, et al. Use of herbal drugs during pregnancy among 600 Norwegian women in relation to concurrent use of conventional drugs and pregnancy outcome. Complementary Therapies in Clinical Practice. 2011; 17:147-51.Link provided by the sponsor.
- 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.
Prof Michael Molloy principal investigator
Consultant Rheumatologist, Consultants Private Clinic, Cork University Hospital, Bishopstown road, Wilton, Cork.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raspberry Leaf Extract in people with Osteoarthritis, Knee, run by Atlantia Food Clinical Trials at 1 site in Ireland.
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 8 inclusion and 23 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 10 Jan 2019. 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 Ireland. 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?
Change, if any, in Pain Scores from baseline to the end of treatment using WOMAC (time frame: 12-13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03703024, which also lists 1 linked publication.
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 10 Jan 2019.