Huangjing Yangji Formula Combined With Resistance Training for Sarcopenia

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.

Conditions

• Sarcopenia

Interventions

DRUG

Huangjing Yangji Formula Granules

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.

DRUG

Placebo Granules for Huangjing Yangji Formula

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.

BEHAVIORAL

Standardized Elastic Band Resistance Training Program

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

  collaborator OTHER

• Hunan University of Traditional Chinese Medicine

  collaborator OTHER

• Wangjing Hospital, China Academy of Chinese Medical Sciences

  lead OTHER

Principal Investigators

• Xu Wei, Ph.D. · Wangjing Hospital, China Academy of Chinese Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-15

Primary Completion

2026-09-30

Completion

2026-12-31

Countries

• China

Study Locations