Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07321535
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT07321535
Study Brief:
Protocol Section:
NCT07321535