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RECRUITING
NCT07597850
PHASE2

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

Sponsor: Tri-Service General Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Effects of Traditional Chinese Medicine (TCM) Formula vs. HMB on Muscle Strength and Bone Status in Pre-Frail Elders: A Comparative Study

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-04-02

Completion Date

2026-12-31

Last Updated

2026-05-19

Healthy Volunteers

No

Interventions

DRUG

TCM Formula

A scientific TCM herbal powder formula prepared by the hospital pharmacy. The formula consists of 10 botanical ingredients focused on tonifying Qi, Blood, Liver, and Kidney. Participants will receive a total daily dose of 18 grams, administered as 9 grams twice daily (BID), 30 minutes before breakfast and lunch.

DIETARY_SUPPLEMENT

HMB (beta-Hydroxy-beta-methylbutyrate)

The active ingredient is beta-hydroxy-beta-methylbutyrate (HMB), provided in 0.75g tablets. Participants will take 2 tablets twice daily (BID) after breakfast and lunch, resulting in a total daily dose of 3 grams. This is a common clinical dose used as a nutritional intervention for muscle strength and physical performance.

Locations (1)

Tri-Service General Hospital

Taipei, Taiwan