Sarcopenia in Elderly
Conditions
Keywords
Sarcopenia in Elderly, Deficiency of Spleen and Kidney Yin, Peiyuan Guben Tongluo Ointment
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.
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_SUPPLEMENTnutritional intervention
Provide protein and vitamin D supplementation.
BEHAVIORALExercise
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.
DRUGPeiyuan 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, 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.
DRUGPeiyuan 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, 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.
Sponsors
Shanghai Yueyang Integrated Medicine Hospital
Shanghai University of Traditional Chinese Medicine
Center for Pharmacometrics, Shanghai University of Traditional Chinese Medicine
Innovation Research Institute of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine
DongE E Jiao Coporation Limited
Institute of Digestive Diseases, Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DXA-measured appendicular skeletal muscle mass | Baseline, week 12, week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper limb handgrip strength | Up to 24 weeks | Use a hand dynamometer to record grip strength data for comparison. |
| Handgrip strength | Baseline, week 12, week 24 | Use a hand dynamometer to record grip strength data for comparison. |
| Timed Up and Go test (TUG) | Baseline, week 12, week 24 | Subjects shall sit on a chair with a seat height of 46 cm, a straight backrest and armrests (armrest height approximately 65 cm). They are required to stand up with minimal assistance from the armrests. The total time is recorded from leaving the backrest to standing upright, walking 3 meters at their usual walking speed, turning around, walking back, and sitting down fully against the chair back. The average value of three trials is calculated. Elderly individuals who routinely use walking aids may use them during the test. |
| Berg Balance Scale (BBS) | Baseline, week 12, week 24 | The scale consists of 14 items in total, including sitting to standing, standing to sitting, standing unsupported, standing with eyes closed, reaching forward with outstretched arms, turning 360 degrees, alternating foot placement on a step, single-leg standing, etc. All items take 10-15 minutes to complete. Each item is scored from a minimum of 0 points to a maximum of 4 points, with a total possible score of 56 points. A higher score indicates better balance function; a score below 40 points suggests an increased risk of falls. |
| TCM Syndrome Score | Baseline, week 12, week 24 | In accordance with the scoring criteria specified in the 《Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs》, the total score for \*\*Spleen-Kidney Deficiency Syndrome\*\* was calculated. |
| Peripheral blood white blood cell count | Baseline, week 12 | Laboratory tests are performed as part of routine safety monitoring to evaluate potential hematological, hepatic, renal, or urinary effects of the investigational treatment. Hematology (Blood Routine): White Blood Cell count (WBC) Unit: ×10⁹/L (Number of white blood cells per liter of blood × 10⁹) |
| Neutrophil count | Baseline, week 12 | Laboratory tests are performed as part of routine safety monitoring to evaluate potential hematological, hepatic, renal, or urinary effects of the investigational treatment. Hematology (Blood Routine): Neutrophil percentage (NEUT%) Unit: % (Percentage of neutrophils among total white blood cells) |
| Interleukin-2 | Baseline, week 12 | Measuring Interleukin-2 (IL-2) level, which is used to evaluate the activation of immune cells and the status of inflammatory response in the body. |
| Interleukin-6 | Baseline, week 12 | Measuring Interleukin-6 (IL-6) level, which serves as an important indicator reflecting the degree of inflammation and stress response in the body. |
| Mini Nutritional Assessment (MNA) | Baseline, week 12, week 24 | Nutritional status was evaluated using the Mini Nutritional Assessment (MNA). This scale comprehensively evaluates an individual's nutritional status through a series of questions covering body weight, dietary intake, mobility, mental state and other aspects. The full score of the scale is 30 points. Grading criteria: a total score ≥ 24 indicates good nutritional status; a score between 17 and 24 suggests risk of malnutrition; a total score below 17 confirms definite malnutrition. |
| Activities of Daily Living (ADL) Scale | Baseline. week 12, week 24 | The Activities of Daily Living (ADL) scale, developed by American scholars Lawton and Brody in 1969, is a medical assessment tool composed of the Physical Self-Maintenance Scale (PSMS) and the Instrumental Activities of Daily Living (IADL). It is mainly used to evaluate subjects' functional levels in basic living skills such as feeding, dressing and mobility, as well as the ability to use instrumental tools. Constructed from two dimensions including PSMS and IADL, the scale contains a total of 10 assessment items. |
Countries
China
Contacts
CONTACTXiao ya Zhang, Undergraduate
PRINCIPAL_INVESTIGATORFeng Hua Qian, Undergraduate
Shanghai Yueyang Integrated Medicine Hospital
Outcome results
None listed