Peiyuan Guben Tongluo Ointment for Elderly Sarcopenia

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.

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

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

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.

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.

In accordance with the scoring criteria specified in the 《Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs》, the total score for **Spleen-Kidney Deficiency Syndrome** was calculated.

Laboratory tests are performed as part of routine safety monitoring to evaluate potential hematological, hepatic, renal, or urinary effects of the investigational treatment. Hematology (Blood Routine): White Blood Cell count (WBC) Unit: ×10⁹/L (Number of white blood cells per liter of blood × 10⁹)

Laboratory tests are performed as part of routine safety monitoring to evaluate potential hematological, hepatic, renal, or urinary effects of the investigational treatment. Hematology (Blood Routine): Neutrophil percentage (NEUT%) Unit: % (Percentage of neutrophils among total white blood cells)

Measuring Interleukin-2 (IL-2) level, which is used to evaluate the activation of immune cells and the status of inflammatory response in the body.

Measuring Interleukin-6 (IL-6) level, which serves as an important indicator reflecting the degree of inflammation and stress response in the body.

Nutritional status was evaluated using the Mini Nutritional Assessment (MNA). This scale comprehensively evaluates an individual's nutritional status through a series of questions covering body weight, dietary intake, mobility, mental state and other aspects. The full score of the scale is 30 points. Grading criteria: a total score ≥ 24 indicates good nutritional status; a score between 17 and 24 suggests risk of malnutrition; a total score below 17 confirms definite malnutrition.

The Activities of Daily Living (ADL) scale, developed by American scholars Lawton and Brody in 1969, is a medical assessment tool composed of the Physical Self-Maintenance Scale (PSMS) and the Instrumental Activities of Daily Living (IADL). It is mainly used to evaluate subjects' functional levels in basic living skills such as feeding, dressing and mobility, as well as the ability to use instrumental tools. Constructed from two dimensions including PSMS and IADL, the scale contains a total of 10 assessment items.

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.

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.

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.

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.

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

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

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

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

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

Laboratory tests are performed as part of routine safety monitoring to evaluate potential hematological, hepatic, renal, or urinary effects of the investigational treatment. Serum Cystatin Unit: mg/L All tests are conducted using standardized clinical laboratory methods at a certified central or local laboratory.

Laboratory tests are performed as part of routine safety monitoring to evaluate potential hematological, hepatic, renal, or urinary effects of the investigational treatment. Hematology (Blood Routine): Red Blood Cell count (RBC) Unit: ×10¹²/L (Number of red blood cells per liter of blood × 10¹²) All tests are conducted using standardized clinical laboratory methods at a certified central or local laboratory. Clinically significant abnormalities or changes are evaluated and reported as adverse events per protocol criteria.

Laboratory tests are performed as part of routine safety monitoring to evaluate potential hematological, hepatic, renal, or urinary effects of the investigational treatment. White Blood Cell count (WBC) Unit: ×10⁹/L (Number of white blood cells per liter of blood × 10⁹) All tests are conducted using standardized clinical laboratory methods at a certified central or local laboratory.

Laboratory tests are performed as part of routine safety monitoring to evaluate potential hematological, hepatic, renal, or urinary effects of the investigational treatment. Hematology (Blood Routine): Hemoglobin (Hb)-Hemoglobin Concentration Unit: g/L (grams per liter) or g/dL All tests are conducted using standardized clinical laboratory methods at a certified central or local laboratory.

Laboratory tests are performed as part of routine safety monitoring to evaluate potential hematological, hepatic, renal, or urinary effects of the investigational treatment. Platelet count (PLT) Unit: ×10⁹/L (Number of platelets per liter of blood × 10⁹) All tests are conducted using standardized clinical laboratory methods at a certified central or local laboratory.

Measuring Fasting Blood Glucose (FBG), which is the blood glucose level measured after fasting for 8 to 12 hours.

Measuring Glycated Hemoglobin (HbA1c), which reflects the average blood glucose concentration over the past 2 to 3 months.

Measuring fasting Total Cholesterol (TC), Low-Density Lipoprotein Cholesterol (LDL-C), High-Density Lipoprotein Cholesterol (HDL-C), and Triglycerides (TG).

Record the occurrence of symptoms such as dry mouth, mouth and tongue ulcers, swollen and painful gums, excessive hunger with increased food intake, and constipation.

Microscopic and chemical examination of fecal specimens to evaluate fecal consistency and color, screen for red blood cells, white blood cells, parasite eggs, occult blood and other indicators, and identify intestinal inflammation, bleeding, infection and abnormal digestion and absorption. Unit of Measure: Qualitative results (-/+/++/+++), quantitative results (cells/HPF).

Body temperature (°C) is measured under standardized conditions (rest ≥5 minutes, using calibrated equipment) by trained study personnel.

Pulse rate (beats per minute, bpm) is measured under standardized conditions (rest ≥5 minutes, using calibrated equipment) by trained study personnel.

Respiratory rate (breaths per minute) is measured under standardized conditions (rest ≥5 minutes, using calibrated equipment) by trained study personnel.

Blood pressure (systolic and diastolic, mmHg) is measured under standardized conditions (rest ≥5 minutes, using calibrated equipment) by trained study personnel. Both systolic blood pressure (SBP) and diastolic blood pressure (DBP) are recorded and reported separately.

Plasma concentration measured from blood samples collected opportunistically at Week 4 (or Week 8/early discontinuation). Cmax is the maximum observed concentration post-dose. Parameters estimated using non-compartmental analysis or population PK modeling due to sparse sampling. Geometric mean and variability reported. Assessed as an exploratory pharmacokinetic biomarker. Unit of Measure: ng/mL (or appropriate unit, e.g., nmol/L)

Area under the concentration-time curve from time zero to the last measurable concentration (AUC0-last) , estimated from sparse opportunistic sampling at Week 4 (or Week 8) using population PK methods. Geometric mean reported. Exploratory PK biomarker of exposure. Unit of Measure: h·ng/mL (or appropriate, e.g., h·nmol/L）

Evaluation of microbial richness and evenness within fecal samples using 16S rRNA sequencing. Alpha-diversity represents the biological variety within a single sample. Unit of Measure: Shannon Diversity Index (a calculated score typically ranging from 0 to 5, where higher values indicate greater diversity).

Assessment of the taxonomic composition of the gut microbiota at the genus and species levels via metagenomic sequencing. Unit of Measure: Percentage of total sequences (%).

Quantitative analysis of major SCFAs (acetate, propionate, and butyrate) using GC-MS. The sum of these concentrations will be reported. Unit of Measure: μ mol/g of feces.

Untargeted metabolomics analysis using LC-MS/GC-MS to identify global metabolic shifts and differential metabolites induced by the treatment. Unit of Measure: Normalized peak intensity (arbitrary units).