About this trial
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.
Eligibility criteria
Qualifiers
Aged between 50 and 75 years.
Willing and able to provide written informed consent personally or via a legal guardian.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Huangjing Yangji Formula Granules
- Placebo Granules for Huangjing Yangji Formula
- Standardized Elastic Band Resistance Training Program
Treatment groups
Sponsors and collaborators
Wangjing Hospital, China Academy of Chinese Medical Sciences
Lead sponsor
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Collaborator
Hunan University of Traditional Chinese Medicine
Collaborator