An Intervention Study Evaluating the Effects of a Raspberry Leaf Extract in an Osteoarthritic Population.

NCT03703024 | Completed DMC

• 1 other identifier: AFCRO-070
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind, randomized, placebo-controlled clinical study to evaluate the efficacy of raspberry extract to alleviate symptoms of osteoarthritis in the knee.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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.

  12-13 weeks

Secondary Outcomes (9)

• Change, if any, from baseline to the end of treatment in WOMAC stiffness sub-score

  12-13 weeks

• Change, if any, from baseline to the end of treatment in WOMAC physical function sub-score.

  12-13 weeks

• Change, if any, from baseline to the end of treatment in WOMAC composite score

  12-13 weeks

• Change, if any, in pain score using the VAS (for target knee joint & all other joints separately)

  12-13 weeks

• Change in Quality of Life scores

  12-13 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Maltodextrin

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.

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.

Dietary Supplement: Raspberry Leaf Extract

Interventions

Raspberry Leaf Extract DIETARY_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.

High dose; Low dose

Placebo DIETARY_SUPPLEMENT

Delivered in a capsule

Also known as: Maltodextrin

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects will be excluded from the study if they meet any of the below criteria;
• \. 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).
• v. 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)
• 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,
• Subject has a history of drug and / or alcohol abuse at the time of enrolment,
• Change of dietary habit within the preceding month,

Sponsors & Collaborators

• Atlantia Food Clinical Trials: lead

Study Sites (1)

Atlantia CRO, Heron House

Blackpool, Munster, T23R50R, Ireland

Location

Related Publications (1)

• 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.

  PMID: 35799169 DERIVED

Related Links

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Prof Michael Molloy

  Consultant Rheumatologist, Consultants Private Clinic, Cork University Hospital, Bishopstown road, Wilton, Cork.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind model
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A double-blind, randomized, placebo-controlled clinical study.

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: October 11, 2018
• Study Start: June 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 10, 2019

Record last verified: 2018-10

Locations

IE (1)