Peiyuan Guben Tongluo Ointment for Elderly Sarcopenia

DXA-measured appendicular skeletal muscle mass

Detected by dual-energy X-ray absorptiometry (GE Healthcare, DXA). The skeletal muscle mass index (SMI) is defined as the ratio of DXA-measured skeletal muscle mass to the square of height.

Upper limb handgrip strength

Use a hand dynamometer to record grip strength data for comparison.

Handgrip strength

Use a hand dynamometer to record grip strength data for comparison.

Timed Up and Go test (TUG)

Subjects shall sit on a chair with a seat height of 46 cm, a straight backrest and armrests (armrest height approximately 65 cm). They are required to stand up with minimal assistance from the armrests. The total time is recorded from leaving the backrest to standing upright, walking 3 meters at their usual walking speed, turning around, walking back, and sitting down fully against the chair back. The average value of three trials is calculated. Elderly individuals who routinely use walking aids may use them during the test.

Berg Balance Scale (BBS)

The scale consists of 14 items in total, including sitting to standing, standing to sitting, standing unsupported, standing with eyes closed, reaching forward with outstretched arms, turning 360 degrees, alternating foot placement on a step, single-leg standing, etc. All items take 10-15 minutes to complete. Each item is scored from a minimum of 0 points to a maximum of 4 points, with a total possible score of 56 points. A higher score indicates better balance function; a score below 40 points suggests an increased risk of falls.

Incidence, Severity, Timing, and Relationship of Adverse Events (AEs)

Adverse events will be evaluated in terms of type, incidence, severity, time of onset, and relationship to the study drug. Types of adverse events are classified as: Adverse Event (AE), Serious Adverse Event (SAE), and Suspected Unexpected Serious Adverse Reaction (SUSAR). Severity is graded as: mild, moderate, or severe. Mild: The subject can tolerate the event; it does not interfere with ongoing treatment, requires no special intervention, and has no impact on the subject's recovery. Moderate: The subject finds the event difficult to tolerate; it necessitates discontinuation of the study drug or special treatment, and it directly affects the subject's recovery. Severe: The event is life-threatening, results in death or permanent disability/incapacity, and requires immediate discontinuation of the study drug or emergency intervention.

Alanine Aminotransferase

Laboratory tests are performed as part of routine safety monitoring to evaluate potential hematological, hepatic, renal, or urinary effects of the investigational treatment. Alanine Aminotransferase (ALT) Unit: U/L (units per liter) All tests are conducted using standardized clinical laboratory methods at a certified central or local laboratory.

γ-Glutamyl Transferase (γ-GT/GGT)

Laboratory tests are performed as part of routine safety monitoring to evaluate potential hematological, hepatic, renal, or urinary effects of the investigational treatment. γ-Glutamyl Transferase (GGT) Unit: U/L (units per liter) All tests are conducted using standardized clinical laboratory methods at a certified central or local laboratory.

Alkaline Phosphatase

Laboratory tests are performed as part of routine safety monitoring to evaluate potential hematological, hepatic, renal, or urinary effects of the investigational treatment. Alkaline Phosphatase (ALP) Unit: U/L (units per liter) All tests are conducted using standardized clinical laboratory methods at a certified central or local laboratory.