Peiyuan Guben Tongluo Ointment for Elderly Sarcopenia

Official title

A Randomized, Double-Blind Clinical Study of Peiyuan Guben Tongluo Ointment in the Treatment of Elderly Sarcopenia (Spleen-Kidney Deficiency Syndrome) With Two Internal and External Controls

Overview

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.

Detailed description

Overall Design: This study adopts a randomized, double-blind clinical trial design with both internal and external controls. Trial Flow: The trial consists of a screening/baseline period, a 12-week treatment administration period, and a 12-week follow-up period. The end-of-trial visit will be conducted at Week 24 after medication administration (EOS/EOT). Randomization and Blinding: Block randomization is applied in this study, with subjects randomized into each group at a 1:1 ratio under a double-blind design. Data Collection: Electronic Data Capture (EDC) system combined with patient diaries. External Control: External controls include published literature data and real-world study data.

Interventions

• Dietary supplement nutritional intervention
  Provide protein and vitamin D supplementation.
• Behavioral Exercise
  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.
• Drug Peiyuan Guben Tongluo Ointment (Ejiao concentrated)
  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, Ci
• Drug Peiyuan Guben Tongluo Ointment (Agarose concentrated)
  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,

Primary outcome measures

• DXA-measured appendicular skeletal muscle mass [Time frame: Baseline, week 12, week 24]

Secondary outcome measures (11)

• Upper limb handgrip strength [Time frame: Up to 24 weeks]
• Handgrip strength [Time frame: Baseline, week 12, week 24]
• Timed Up and Go test (TUG) [Time frame: Baseline, week 12, week 24]
• Berg Balance Scale (BBS) [Time frame: Baseline, week 12, week 24]
• TCM Syndrome Score [Time frame: Baseline, week 12, week 24]
• Peripheral blood white blood cell count [Time frame: Baseline, week 12]
• Neutrophil count [Time frame: Baseline, week 12]
• Interleukin-2 [Time frame: Baseline, week 12]
• Interleukin-6 [Time frame: Baseline, week 12]
• Mini Nutritional Assessment (MNA) [Time frame: Baseline, week 12, week 24]
• Activities of Daily Living (ADL) Scale [Time frame: Baseline. week 12, week 24]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Yueyang Integrated Medicine Hospital — Shanghai

Identifiers

NCT: NCT07538674 · YY-PYGBTLG-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗