Huangjing Yangji Formula Combined With Resistance Training for Sarcopenia: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Wangjing Hospital, China Academy of Chinese Medical Sciences
- Enrollment
- 106
- Locations
- 3
- Primary Endpoint
- Short Physical Performance Battery (SPPB) Score
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Meets the diagnostic criteria for sarcopenia according to the Asian Working Group for Sarcopenia (AWGS) 2025 consensus, defined as the co-presence of:
- •Low Muscle Mass: Appendicular skeletal muscle index (ASMI) measured by multi-frequency bioelectrical impedance analysis (BIA) below the following thresholds:
- •Ages 50-64: \<7.6 kg/m² for men, \<5.7 kg/m² for women. Ages ≥65: \<7.0 kg/m² for men, \<5.7 kg/m² for women.
- •Low Muscle Strength: Handgrip strength below the following thresholds:
- •Ages 50-64: \<34 kg for men, \<20 kg for women. Ages ≥65: \<28 kg for men, \<18 kg for women.
- •Meets the Traditional Chinese Medicine (TCM) pattern diagnosis criteria for Spleen-Kidney Deficiency Syndrome, characterized by:
- •Primary Symptoms: Muscle wasting, general fatigue, soreness and weakness of the lower back and knees.
- •Secondary Symptoms: Poor appetite, abdominal distension, loose or chronic diarrhea, dizziness, poor memory. Tongue presentation: pale and swollen tongue with tooth marks, white and glossy coating. Pulse: deep, thin, and weak.
- •Aged between 50 and 75 years.
- •Willing and able to provide written informed consent personally or via a legal guardian.
Exclusion Criteria
- •Secondary sarcopenia due to specific diseases (e.g., active malignancy, hyperthyroidism, severe hepatic or renal dysfunction).
- •Presence of severe or uncontrolled cardiovascular disease, consumptive diseases (e.g., cancer), active infections, or severe osteoporosis.
- •Diagnosis of Alzheimer's disease, psychiatric disorders, or other cognitive/mental impairments that would hinder cooperation with the trial procedures.
- •Inability to perform activities of daily living or walk independently; or presence of motor dysfunction due to joint deformities, prolonged bed rest, fractures, or other reasons that would preclude safe participation in resistance training.
- •Known contraindications to the ingredients of the investigational herbal formula or allergy to the materials of the elastic bands.
- •Use of medications known to affect muscle metabolism (e.g., corticosteroids, muscle relaxants) within the past 3 months.
- •Participation in any other interventional clinical trial within the past 3 months.
Arms & Interventions
Huangjing Yangji Formula + Training
Participants in this group will take "Huangjing Yangji Formula" granules orally. The formula consists of 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 per daily dose. The granules are taken twice daily, 30 minutes after meals, for a total treatment period of 3 months. Additionally, all participants in this group will simultaneously complete the standardized elastic band resistance training program 3 times per week for 3 months.
Intervention: Huangjing Yangji Formula Granules (Drug)
Huangjing Yangji Formula + Training
Participants in this group will take "Huangjing Yangji Formula" granules orally. The formula consists of 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 per daily dose. The granules are taken twice daily, 30 minutes after meals, for a total treatment period of 3 months. Additionally, all participants in this group will simultaneously complete the standardized elastic band resistance training program 3 times per week for 3 months.
Intervention: Standardized Elastic Band Resistance Training Program (Behavioral)
Placebo + Training
Participants in this group will take matched placebo granules orally. The placebo is designed to be identical to the investigational "Huangjing Yangji Formula" granules in appearance, color, odor, packaging, and solubility, but it contains no active herbal components. The placebo granules are taken twice daily, 30 minutes after meals, for a total treatment period of 3 months. Additionally, all participants in this group will simultaneously complete the identical standardized elastic band resistance training program 3 times per week for 3 months.
Intervention: Placebo Granules for Huangjing Yangji Formula (Drug)
Placebo + Training
Participants in this group will take matched placebo granules orally. The placebo is designed to be identical to the investigational "Huangjing Yangji Formula" granules in appearance, color, odor, packaging, and solubility, but it contains no active herbal components. The placebo granules are taken twice daily, 30 minutes after meals, for a total treatment period of 3 months. Additionally, all participants in this group will simultaneously complete the identical standardized elastic band resistance training program 3 times per week for 3 months.
Intervention: Standardized Elastic Band Resistance Training Program (Behavioral)
Outcomes
Primary Outcomes
Short Physical Performance Battery (SPPB) Score
Time Frame: Baseline, 3 months, and 4 months (1-month follow-up).
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.
Secondary Outcomes
- 4-Meter Walking Speed(Baseline, 3 months, and 4 months (1-month follow-up).)
- Timed Up and Go Test (TUG)(Baseline, 3 months, and 4 months (1-month follow-up).)
- Handgrip Strength(Baseline, 3 months, and 4 months (1-month follow-up).)
- Tinetti Performance-Oriented Mobility Assessment (POMA)(Baseline, 3 months, and 4 months (1-month follow-up).)
- Appendicular Skeletal Muscle Index (ASMI)(Baseline, 3 months, and 4 months (1-month follow-up).)
- Lean Body Mass(Baseline, 3 months, and 4 months (1-month follow-up).)
- Fat Mass(Baseline, 3 months, and 4 months (1-month follow-up).)
- Body Fat Percentage(Baseline, 3 months, and 4 months (1-month follow-up).)
- Body Mass Index (BMI)(Baseline, 3 months, and 4 months (1-month follow-up).)
- FRAIL Scale Score(Baseline, 3 months, and 4 months (1-month follow-up).)
- Barthel Index Score(Baseline, 3 months, and 4 months (1-month follow-up).)
- Geriatric Depression Scale (GDS) Score(Baseline, 3 months, and 4 months (1-month follow-up).)
- Mini Nutritional Assessment - Short Form (MNA-SF) Score(Baseline, 3 months, and 4 months (1-month follow-up).)
- Pittsburgh Sleep Quality Index (PSQI) Score(Baseline, 3 months, and 4 months (1-month follow-up).)
- 12-Item Short Form Health Survey (SF-12) score(Baseline, 3 months, and 4 months (1-month follow-up).)
- Serum Biomarker Levels(Baseline and 3 months of intervention.)
- Traditional Chinese Medicine (TCM) Syndrome Score(Baseline, 3 months, and 4 months (1-month follow-up).)