Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:05 AM
Study NCT ID:
NCT07321535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Huangjing Yangji Formula Combined With Resistance Training for Sarcopenia
Sponsor:
Wangjing Hospital, China Academy of Chinese Medical Sciences
Organization:
Study Overview
Official Title:
Huangjing Yangji Formula Combined With Resistance Training for Sarcopenia: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: