The goal of this clinical trial is to learn if a traditional Chinese medicine formula called "Huangjing Yangji Formula," combined with elastic band resistance training, works better than exercise alone to improve physical function and muscle strength in older adults with sarcopenia (age-related muscle loss). The main questions it aims to answer are: Does the combined treatment improve participants' overall physical performance scores more than exercise with a placebo? Does it lead to better outcomes in walking speed, balance, muscle strength, body composition, nutrition, mood, sleep, and overall quality of life? Researchers will compare two groups. One group will take the real Huangjing Yangji Formula granules and do the standardized elastic band resistance training. The other group will take placebo granules (a look-alike mixture with no active medicine) and do the same training. Participants will: Take the assigned granules twice daily for 3 months. Complete a standardized elastic band exercise program 3 times per week for 3 months (with both group and home sessions). Attend three assessment visits (at the start, after 3 months, and 1 month after treatment) for tests and questionnaires. Provide blood samples at the start and after 3 months for routine safety tests and special muscle health markers.
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of the traditional Chinese medicine prescription"Huangjing Yangji Formula" combined with elastic band resistance training for treating sarcopenia adults. A total of 106 eligible participants will be recruited from three tertiary hospitals in China and randomly assigned (1:1) to two groups. The experimental group will receive Huangjing Yangji Formula granules (composition: Polygonati rhizoma 15g, Codonopsis radix 10g, Rehmanniae radix praeparata 9g, Angelica sinensis radix 6g, Cistanches herba 9g, Lycii fructus 12g, Poria 9g, Crataegi fructus 6g) orally twice daily for 3 months. The control group will receive matched placebo granules on the same schedule. Both groups will simultaneously perform a standardized elastic band resistance training program 3 times per week for 3 months. The primary outcome is the change in the Short Physical Performance Battery (SPPB) score from baseline to 3 months. Secondary outcomes include physical function (gait speed, Timed Up and Go test, handgrip strength, Tinetti POMA score), body composition, frailty (FRAIL scale), activities of daily living (Barthel Index), nutrition (MNA-SF), psychological status (GDS-30, PSQI), quality of life (SF-12), TCM syndrome score, and serum biomarkers of inflammation and muscle metabolism. Outcome assessments occur at baseline, 3 months, and at a 1-month follow-up (4 months), except for serum biomarkers measured only at baseline and 3 months. Safety will be monitored through laboratory tests and adverse event recording.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
106
Investigational herbal granule formulation. Each daily dose contains: Polygonati rhizoma (Huangjing) 15g, Codonopsis radix (Dangshen) 10g, Rehmanniae radix praeparata (Shudi) 9g, Angelica sinensis radix (Danggui) 6g, Cistanches herba (Roucongrong) 9g, Lycii fructus (Gouqi) 12g, Poria (Fuling) 9g, and Crataegi fructus (Shanzha) 6g. Administered orally as granules dissolved in water, twice daily (30 minutes after meals), for a period of 3 months.
Matched placebo granules. This preparation is specifically designed to be indistinguishable from the active "Huangjing Yangji Formula Granules" in terms of appearance, color, odor, packaging, and solubility. It contains no pharmacologically active herbal components. Administered orally in the same manner (twice daily, 30 minutes after meals) for 3 months.
A structured, progressive resistance training program using elastic bands. Participants train 3 times per week for 3 months. Each 60-minute session includes warm-up, 10 core strength exercises (e.g., standing row, leg extension, bridge), and cool-down. Intensity is progressively increased from low (approximately 40-60% of 1-RM) to medium-high (approximately 60-80% of 1-RM) resistance. Sessions are supervised once weekly, with twice-weekly home-based sessions.
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Short Physical Performance Battery (SPPB) Score
The SPPB is a composite score ranging from 0 to 12 that assesses lower extremity physical function. It combines three tests: standing balance, 4-meter walking speed, and time to complete five chair stands. Scores are interpreted as: 0-3 (severe limitation), 4-6 (mild limitation), 7-9 (normal function), and 10-12 (excellent function). A higher score indicates better physical performance.
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
4-Meter Walking Speed
Usual walking speed (in meters per second) assessed over a 4-meter course. Participants are instructed to walk at their normal, comfortable pace. The average speed of two trials is calculated and used for analysis. This is a key measure of mobility and functional capacity.
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
Timed Up and Go Test (TUG)
Time (in seconds) required to stand up from a standard armchair, walk 3 meters at a usual pace, turn around, walk back, and sit down again. The test is performed twice, and the shorter time of the two trials is recorded. It is a widely used measure of functional mobility and fall risk.
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
Handgrip Strength
Maximal isometric strength of the dominant hand, measured in kilograms (kg) using a handheld dynamometer (handgrip). The participant is seated with the forearm supported. Three trials are performed, and the highest value is recorded as the outcome. It is a standard measure of overall muscle strength.
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
Tinetti Performance-Oriented Mobility Assessment (POMA)
Total score on the POMA, a standardized tool to assess balance and walking ability. It consists of a Balance subscale (9 items, score 0-16) and a Gait subscale (7 items, score 0-12). The total score ranges from 0 to 28, with a higher score indicating better mobility and lower fall risk. Scores are interpreted as: ≤18 (high fall risk), 19-24 (moderate fall risk), ≥25 (low fall risk).
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
Appendicular Skeletal Muscle Index (ASMI)
The appendicular skeletal muscle mass (sum of muscle mass in both arms and legs) measured in kilograms (kg) using a multi-frequency BIA device (InBody 770C), divided by the square of height in meters to yield ASMI in kg/m².
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
Lean Body Mass
Lean body mass measured in kilograms (kg) using a multi-frequency bioelectrical impedance analysis (BIA) device (InBody 770C).
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
Fat Mass
Fat mass measured in kilograms (kg) using a multi-frequency bioelectrical impedance analysis (BIA) device (InBody 770C).
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
Body Fat Percentage
Body fat percentage measured in percent (%) using a multi-frequency bioelectrical impedance analysis (BIA) device (InBody 770C).
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
Body Mass Index (BMI)
Body Mass Index calculated as weight in kilograms divided by height in meters squared (kg/m²). Weight and height are obtained using a multi-frequency bioelectrical impedance analysis (BIA) device (InBody 770C).
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
FRAIL Scale Score
Total score on the FRAIL scale, a brief screening tool based on the frailty phenotype. It assesses five components: Fatigue, Resistance (difficulty climbing stairs), Ambulation (difficulty walking), Illnesses (number of comorbidities), and Loss of weight. Each component present scores 1 point. Total scores range from 0 to 5 and are interpreted as: 0 (robust/no frailty), 1-2 (pre-frail), and ≥3 (frail).
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
Barthel Index Score
Total score on the Barthel Index, a measure of independence in performing basic activities of daily living (ADL). It assesses 10 items: feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, bed-chair transfer, ambulation, and stair climbing. Each item is scored 0, 5, 10, or 15 based on the level of assistance required. Total scores range from 0 to 100 and are interpreted as: 0-20 (total dependence), 25-45 (severe dependence), 50-70 (moderate dependence), 75-95 (mild dependence), 100 (complete independence).
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
Geriatric Depression Scale (GDS) Score
Total score on the 30-item GDS, a self-report measure designed specifically to assess depressive symptoms, focusing on mood and cognition while minimizing somatic items. Scores range from 0 to 30. A total score of ≥11 indicates the presence of depressive symptoms, with scores of 11-20 suggesting mild depression and scores of 21-30 suggesting moderate to severe depression.
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
Mini Nutritional Assessment - Short Form (MNA-SF) Score
Total score on the MNA-SF, a 6-item screening tool used to assess nutritional status or risk of malnutrition. Total scores range from 0 to 14 and are interpreted as: 12-14 (normal nutritional status), 8-11 (at risk of malnutrition), and 0-7 (malnourished).
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
Pittsburgh Sleep Quality Index (PSQI) Score
Global score on the PSQI, a 19-item self-rated questionnaire assessing sleep quality and disturbances over the past month. The score encompasses seven components. Total scores range from 0 to 21, interpreted as: 0-5 (good sleep quality), 6-10 (mild sleep disturbance), 11-15 (moderate sleep disturbance), and 16-21 (severe sleep disturbance).
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
12-Item Short Form Health Survey (SF-12) score
Scores on the SF-12, a shortened version of the SF-36 used to efficiently assess health-related quality of life. It yields two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Both are standardized scores, with higher values indicating better physical or mental health-related quality of life.
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
Serum Biomarker Levels
Fasting venous blood samples will be collected, processed within 30 minutes, and stored for batch analysis. Levels of the following biomarkers will be quantified using standard methods: inflammatory markers (Tumor Necrosis Factor-alpha, Interleukin-6, Interleukin-1beta), muscle metabolism markers (Irisin, Myostatin), and metabolic hormones (25-Hydroxyvitamin D, Insulin-like Growth Factor-1, Growth Hormone).
Time frame: Baseline and 3 months of intervention.
Traditional Chinese Medicine (TCM) Syndrome Score
The TCM syndrome score is assessed according to the《Guiding Principles for Clinical Research of New Chinese Medicines》. It evaluates three primary symptoms (muscle wasting, general fatigue, soreness and weakness of the lower back) and five secondary symptoms (poor appetite, abdominal distension, loose stools, dizziness, forgetfulness). Primary symptoms are scored 0 (none), 2 (mild), 4 (moderate), or 6 (severe); secondary symptoms are scored 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The total score is the sum of all items, with a higher score indicating more severe symptoms. Efficacy is categorized based on the percentage reduction in the total score after treatment: ≥70% (markedly effective), 30-69% (effective), \<30% (ineffective).
Time frame: Baseline, 3 months, and 4 months (1-month follow-up).
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