Huangjing Yangji Formula Combined With Resistance Training for Sarcopenia

Официальное название

Huangjing Yangji Formula Combined With Resistance Training for Sarcopenia: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Обзор

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.

Подробное описание

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of the traditional Chinese medicine prescription"Huangjing Yangji Formula" combined with elastic band resistance training for treating sarcopenia adults. A total of 106 eligible participants will be recruited from three tertiary hospitals in China and randomly assigned (1:1) to two groups. The experimental group will receive Huangjing Yangji Formula granules (composition: Polygonati rhizoma 15g, Codonopsis radix 10g, Rehmanniae radix praeparata 9g, Angelica sinensis radix 6g, Cistanches herba 9g, Lycii fructus 12g, Poria 9g, Crataegi fructus 6g) orally twice daily for 3 months. The control group will receive matched placebo granules on the same schedule. Both groups will simultaneously perform a standardized elastic band resistance training program 3 times per week for 3 months. The primary outcome is the change in the Short Physical Performance Battery (SPPB) score from baseline to 3 months. Secondary outcomes include physical function (gait speed, Timed Up and Go test, handgrip strength, Tinetti POMA score), body composition, frailty (FRAIL scale), activities of daily living (Barthel Index), nutrition (MNA-SF), psychological status (GDS-30, PSQI), quality of life (SF-12), TCM syndrome score, and serum biomarkers of inflammation and muscle metabolism. Outcome assessments occur at baseline, 3 months, and at a 1-month follow-up (4 months), except for serum biomarkers measured only at baseline and 3 months. Safety will be monitored through laboratory tests and adverse event recording.

Вмешательства

• Препарат 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.
• Препарат 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.
• Поведенческое 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.

Первичные конечные точки

• Short Physical Performance Battery (SPPB) Score [Срок оценки: Baseline, 3 months, and 4 months (1-month follow-up).]

Вторичные конечные точки (12)

• 4-Meter Walking Speed [Срок оценки: Baseline, 3 months, and 4 months (1-month follow-up).]
• Timed Up and Go Test (TUG) [Срок оценки: Baseline, 3 months, and 4 months (1-month follow-up).]
• Handgrip Strength [Срок оценки: Baseline, 3 months, and 4 months (1-month follow-up).]
• Tinetti Performance-Oriented Mobility Assessment (POMA) [Срок оценки: Baseline, 3 months, and 4 months (1-month follow-up).]
• Appendicular Skeletal Muscle Index (ASMI) [Срок оценки: Baseline, 3 months, and 4 months (1-month follow-up).]
• Lean Body Mass [Срок оценки: Baseline, 3 months, and 4 months (1-month follow-up).]
• Fat Mass [Срок оценки: Baseline, 3 months, and 4 months (1-month follow-up).]
• Body Fat Percentage [Срок оценки: Baseline, 3 months, and 4 months (1-month follow-up).]
• Body Mass Index (BMI) [Срок оценки: Baseline, 3 months, and 4 months (1-month follow-up).]
• FRAIL Scale Score [Срок оценки: Baseline, 3 months, and 4 months (1-month follow-up).]
• Barthel Index Score [Срок оценки: Baseline, 3 months, and 4 months (1-month follow-up).]
• Geriatric Depression Scale (GDS) Score [Срок оценки: Baseline, 3 months, and 4 months (1-month follow-up).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Wangjing Hospital, China Academy of Chinese Medical Sciences — Пекин
• The First Affiliated Hospital of Hunan University of Chinese Medicine — Чанша
• The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine — Тяньцзинь

Идентификаторы

NCT: NCT07321535 · WJEC-KT-2025-040-P001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗