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Table 2 Inclusion criteria

From: Effects of dietary supplementation with a standardized aqueous extract of Terminalia chebula fruit (AyuFlex®) on joint mobility, comfort, and functional capacity in healthy overweight subjects: a randomized placebo-controlled clinical trial

Healthy male or female volunteers ≥35 to ≤70 years of age.

Able to understand study procedures and provide signed informed consent, and authorizes release of relevant health information to study investigator.

Willing to maintain current background dietary and physical activity pattern throughout study period.

Normally active and otherwise judged to be in good health on the basis of medical history and physical examination.

Knee joint:

No knee joint discomfort at rest.

Experience knee joint discomfort with activity or exercise within the last 2 weeks of at least 30 mm out of 100 mm on VAS rating for “knee discomfort with activity or exercise at any time over the last 2 weeks”.

Must achieve a rating of at least 30 mm on a 100 mm VAS at any point throughout the standardized lower extremity exercise performance screening test (Screening test = 3 sets of 10–12 repetitions on seated knee extension machine +3-min walk test at maximal walking velocity).

Females:

Non-pregnant, non-lactating females who agree to use effective contraceptive methods throughout the course of the study.

Females of childbearing potential must agree to use one of the following acceptable birth control methods:

Surgically sterile (hysterectomy or bilateral oophorectomy);

Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation)

Intrauterine device (IUD) in place for at least 3 months

Abstinence (not having sexual intercourse)

Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening and through study completion