TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status

The purpose of this study is to compare the effects of a standardized Traditional Chinese Medicine (TCM) formula versus beta-hydroxy-beta-methylbutyrate (HMB) on muscle strength and bone health in pre-frail older adults . Pre-frailty is a critical stage where functional decline may still be reversed through proper intervention. The study will enroll 90 participants aged 65 years or older who meet the criteria for pre-frailty. Participants will be randomly assigned to either the TCM group (receiving a standardized herbal powder formula) or the HMB group (receiving nutritional supplement tablets) for 24 weeks . The primary objective is to evaluate the change in handgrip strength from baseline to Week 12 . Researchers will also assess changes in skeletal muscle mass, bone mineral density, and overall physical performance . The goal is to determine if the TCM formula is an effective alternative or complementary intervention for managing geriatric frailty.

NCT Number	NCT07597850
Lead Sponsor	Tri-Service General Hospital Collaborators: National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Conditions	Pre-Frailty, Sarcopenia, Muscle Atrophy or Weakness, Osteoporosis, Aging
Enrollment	90 participants
Start Date	2026-04-02
Primary Completion	2026-10-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-19