Clinical trial: An Intervention Study Evaluating the Effects of a Raspberry Leaf Extract in an Osteoarthritic Population. (NCT03703024)

Eligibility criteria:
Inclusion Criteria:

        To be considered eligible for enrolment into the study, subjects must;

          1. Be aged 30 to 75 years (inclusive),

          2. Be willing to provide informed consent,

          3. Have a BMI between 18.5 and 32 kg/m2,

          4. Have documented diagnosis of primary osteoarthritis (OA) of the target knee made at
             least 12 months prior to Screening,

          5. 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,

          6. Have mild to moderate pain not adequately or completely controlled with
             anti-inflammatory drugs,

          7. Be able to perform the 20-meter walking test and to understand all questions from the
             WOMAC questionnaire.

        Exclusion Criteria:

        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).

             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.

               1. Patient with secondary OA (due to a known disorder)

               2. 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,

               3. Has clinically apparent tense effusion of the target knee or other joint,

               4. Has had viscosupplementation in any joint including the target knee or other
                  joint within 9 months prior to Screening,

               5. Subject is taking any anti-inflammatory steroid medications, salicylates
                  (aspirin) or Propionic acid derivatives (ibuprofen), for 2 weeks prior to study
                  entry,

               6. 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.),

               7. Symptomatic OA of the contralateral knee that is not responsive to paracetamol
                  and requires other therapy,

               8. Taking any calcium supplements (4-week washout) or other supplement e.g.
                  glucosamine, chondroitin,

               9. Any medical condition deemed exclusionary by the Principal Investigator/Study
                  doctor,

              10. Subject has a history of drug and / or alcohol abuse at the time of enrolment,

              11. Change of dietary habit within the preceding month,

              12. Subject with known organic disease, including an inflammatory bowel disease, a
                  benign or malign tumour of intestine or colon and significant systemic disease,

              13. Subject currently involved in any other clinical trial or having participated in
                  a trial within the preceding 90 days,

              14. Subject with known allergy to components of the test product,

              15. 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,

              16. 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,

              17. 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,

              18. Current illnesses which could interfere with the study (e.g. prolonged severe
                  diarrhea, regurgitation/severe, difficulty swallowing).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment