Huangjing Yangji Formula Combined With Resistance Training for Sarcopenia
NCT ID: NCT07321535
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
106 participants
INTERVENTIONAL
2026-01-15
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Huangjing Yangji Formula + Training
Participants in this group will take "Huangjing Yangji Formula" granules orally. The formula consists of 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 per daily dose. The granules are taken twice daily, 30 minutes after meals, for a total treatment period of 3 months. Additionally, all participants in this group will simultaneously complete the standardized elastic band resistance training program 3 times per week for 3 months.
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.
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.
Placebo + Training
Participants in this group will take matched placebo granules orally. The placebo is designed to be identical to the investigational "Huangjing Yangji Formula" granules in appearance, color, odor, packaging, and solubility, but it contains no active herbal components. The placebo granules are taken twice daily, 30 minutes after meals, for a total treatment period of 3 months. Additionally, all participants in this group will simultaneously complete the identical standardized elastic band resistance training program 3 times per week for 3 months.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
* 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.
50 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
OTHER
Hunan University of Traditional Chinese Medicine
OTHER
Wangjing Hospital, China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Xu Wei, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Wangjing Hospital, China Academy of Chinese Medical Sciences
Locations
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Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WJEC-KT-2025-040-P001
Identifier Type: -
Identifier Source: org_study_id
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