Huangjing Yangji Formula Combined With Resistance Training for Sarcopenia
1 other identifier
interventional
106
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2025
CompletedFirst Posted
Study publicly available on registry
January 7, 2026
CompletedStudy Start
First participant enrolled
January 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
January 7, 2026
January 1, 2026
9 months
December 21, 2025
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 3 months, and 4 months (1-month follow-up).
Secondary Outcomes (17)
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).
- +12 more secondary outcomes
Study Arms (2)
Huangjing Yangji Formula + Training
EXPERIMENTALParticipants 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.
Placebo + Training
PLACEBO COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100102, China
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410021, China
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300381, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xu Wei, Ph.D.
Wangjing Hospital, China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2025
First Posted
January 7, 2026
Study Start
January 15, 2026
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared publicly due to the need to protect participant privacy and in accordance with the data management policies of the participating hospitals in this multicenter trial.