NCT07538674

Brief Summary

With the agarose concentrating group of Peiyuan Guben Tongluo Ointment set as the parallel control and an external control established simultaneously, this study aimed to evaluate the increases from baseline in DXA-measured limb muscle mass after 12 weeks of medication in elderly sarcopenia patients treated with the Ejiao concentrating group of Peiyuan Guben Tongluo Ointment.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
33mo left

Started Apr 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Dec 2028

Study Start

First participant enrolled

April 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 6, 2026

Last Update Submit

April 15, 2026

Conditions

Sarcopenia in Elderly

Keywords

Sarcopenia in ElderlyDeficiency of Spleen and Kidney YinPeiyuan Guben Tongluo Ointment

Outcome Measures

Primary Outcomes (1)

  • DXA-measured appendicular skeletal muscle mass

    Detected by dual-energy X-ray absorptiometry (GE Healthcare, DXA). The skeletal muscle mass index (SMI) is defined as the ratio of DXA-measured skeletal muscle mass to the square of height.

    Baseline, week 12, week 24

Secondary Outcomes (11)

  • Upper limb handgrip strength

    Up to 24 weeks

  • Handgrip strength

    Baseline, week 12, week 24

  • Timed Up and Go test (TUG)

    Baseline, week 12, week 24

  • Berg Balance Scale (BBS)

    Baseline, week 12, week 24

  • TCM Syndrome Score

    Baseline, week 12, week 24

  • +6 more secondary outcomes

Other Outcomes (29)

  • Incidence, Severity, Timing, and Relationship of Adverse Events (AEs)

    Baseline, week 12, week 24

  • Alanine Aminotransferase

    Baseline, week 12

  • γ-Glutamyl Transferase (γ-GT/GGT)

    Baseline, week 12

  • +26 more other outcomes

Study Arms (2)

Peiyuan Guben Tongluo Ointment (Ejiao concentrated)

EXPERIMENTAL

Peiyuan Guben Tongluo Ointment (Ejiao concentrated): 20 g once daily, administered with warm water; Composition: Rehmanniae Radix Preparata 120 g, Rehmanniae Radix 120 g, Epimedii Folium 60 g, Achyranthis Bidentatae Radix 120 g, Eucommiae Cortex 60 g, Dipsaci Radix 90 g, Astragali Radix 150 g, Codonopsis Radix 150 g, Dioscoreae Rhizoma 150 g, Paeoniae Radix Alba (stir-fried) 120 g, Polygonati Odorati Rhizoma 100 g, Scrophulariae Radix 90 g, Ligustri Lucidi Fructus 100 g, Ecliptae Herba 100 g, Citri Reticulatae Pericarpium 90 g, Atractylodis Macrocephalae Rhizoma (stir-fried) 150 g, Aucklandiae Radix 30 g, Salviae Miltiorrhizae Radix et Rhizoma 120 g, Chuanxiong Rhizoma 60 g, Sedii Aizi Herba 120 g, Anemarrhenae Rhizoma 90 g; Excipients: Agarose 450 g, Xylitol 45 g. Excipients: Tortoise Shell Glue 150 g, Deer Horn Glue 150 g, Ejiao 150 g, Xylitol 45 g.

Dietary Supplement: nutritional interventionBehavioral: ExerciseDrug: Peiyuan Guben Tongluo Ointment (Ejiao concentrated)

Peiyuan Guben Tongluo Ointment (Agarose concentrated)

PLACEBO COMPARATOR

Peiyuan Guben Tongluo Ointment (Agarose concentrated): 20 g once daily, administered with warm water; Composition: Rehmanniae Radix Preparata 120 g, Rehmanniae Radix 120 g, Epimedii Folium 60 g, Achyranthis Bidentatae Radix 120 g, Eucommiae Cortex 60 g, Dipsaci Radix 90 g, Astragali Radix 150 g, Codonopsis Radix 150 g, Dioscoreae Rhizoma 150 g, Paeoniae Radix Alba (stir-fried) 120 g, Polygonati Odorati Rhizoma 100 g, Scrophulariae Radix 90 g, Ligustri Lucidi Fructus 100 g, Ecliptae Herba 100 g, Citri Reticulatae Pericarpium 90 g, Atractylodis Macrocephalae Rhizoma (stir-fried) 150 g, Aucklandiae Radix 30 g, Salviae Miltiorrhizae Radix et Rhizoma 120 g, Chuanxiong Rhizoma 60 g, Sedii Aizi Herba 120 g, Anemarrhenae Rhizoma 90 g; Excipients: Agarose 450 g, Xylitol 45 g.

Dietary Supplement: nutritional interventionBehavioral: ExerciseDrug: Peiyuan Guben Tongluo Ointment (Agarose concentrated)

Interventions

nutritional interventionDIETARY_SUPPLEMENT

Provide protein and vitamin D supplementation.

Peiyuan Guben Tongluo Ointment (Agarose concentrated)Peiyuan Guben Tongluo Ointment (Ejiao concentrated)
ExerciseBEHAVIORAL

Receive standardized Baduanjin training with unified movements; the training is conducted 3 times weekly, starting 3 hours after meals, with a duration of 30 minutes per session.

Peiyuan Guben Tongluo Ointment (Agarose concentrated)Peiyuan Guben Tongluo Ointment (Ejiao concentrated)
Peiyuan Guben Tongluo Ointment (Ejiao concentrated)DRUG

Peiyuan Guben Tongluo Ointment (Ejiao concentrated): 20 g once daily, administered with warm water; Composition: Rehmanniae Radix Preparata 120 g, Rehmanniae Radix 120 g, Epimedii Folium 60 g, Achyranthis Bidentatae Radix 120 g, Eucommiae Cortex 60 g, Dipsaci Radix 90 g, Astragali Radix 150 g, Codonopsis Radix 150 g, Dioscoreae Rhizoma 150 g, Paeoniae Radix Alba (stir-fried) 120 g, Polygonati Odorati Rhizoma 100 g, Scrophulariae Radix 90 g, Ligustri Lucidi Fructus 100 g, Ecliptae Herba 100 g, Citri Reticulatae Pericarpium 90 g, Atractylodis Macrocephalae Rhizoma (stir-fried) 150 g, Aucklandiae Radix 30 g, Salviae Miltiorrhizae Radix et Rhizoma 120 g, Chuanxiong Rhizoma 60 g, Sedii Aizi Herba 120 g, Anemarrhenae Rhizoma 90 g; Excipients: Agarose 450 g, Xylitol 45 g. Excipients: Tortoise Shell Glue 150 g, Deer Horn Glue 150 g, Ejiao 150 g, Xylitol 45 g.

Peiyuan Guben Tongluo Ointment (Ejiao concentrated)
Peiyuan Guben Tongluo Ointment (Agarose concentrated)DRUG

Peiyuan Guben Tongluo Ointment (Agarose concentrated): 20 g once daily, administered with warm water; Composition: Rehmanniae Radix Preparata 120 g, Rehmanniae Radix 120 g, Epimedii Folium 60 g, Achyranthis Bidentatae Radix 120 g, Eucommiae Cortex 60 g, Dipsaci Radix 90 g, Astragali Radix 150 g, Codonopsis Radix 150 g, Dioscoreae Rhizoma 150 g, Paeoniae Radix Alba (stir-fried) 120 g, Polygonati Odorati Rhizoma 100 g, Scrophulariae Radix 90 g, Ligustri Lucidi Fructus 100 g, Ecliptae Herba 100 g, Citri Reticulatae Pericarpium 90 g, Atractylodis Macrocephalae Rhizoma (stir-fried) 150 g, Aucklandiae Radix 30 g, Salviae Miltiorrhizae Radix et Rhizoma 120 g, Chuanxiong Rhizoma 60 g, Sedii Aizi Herba 120 g, Anemarrhenae Rhizoma 90 g; Excipients: Agarose 450 g, Xylitol 45 g.

Peiyuan Guben Tongluo Ointment (Agarose concentrated)

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥ 60 years and ≤ 80 years, regardless of gender; ② Patients meeting the diagnostic criteria for sarcopenia in the elderly according to both traditional Chinese medicine (TCM) and Western medicine;
  • Patients meeting the TCM diagnostic criteria for Spleen-Kidney Deficiency Syndrome;
  • Able to take oral medications, willing to comply with the study intervention protocol, able to attend follow-up visits on time, and have signed the informed consent form.

You may not qualify if:

  • Patients with quadriplegia, long-term bedridden status, zero muscle strength due to severe cerebrovascular accident, muscle atrophy caused by various factors, or inability to perform activities of daily living;
  • Patients with unclear consciousness, aphasia, delirium, inability to respond, or impaired time, location and orientation due to senile or vascular dementia;
  • Patients with severe mental illness, depressive state, or receiving relevant psychotropic medication; ④ Patients complicated with tumors, severe infections, gastrointestinal bleeding, hepatic and renal insufficiency, cardiac insufficiency, or other diseases affecting nutritional status; ⑤ Patients with hypersensitivity to the study drugs; patients who have received or are receiving traditional Chinese medicine treatment within the past 1 month; patients who have received medications affecting muscle contraction/relaxation within the past 1 month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, 200437, China

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Feng Hua Qian, Undergraduate

    Shanghai Yueyang Integrated Medicine Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao ya Zhang, Undergraduate

CONTACT

+86 136453378902365672026@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 20, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)