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Sarcopenia in ElderlyPhase 2NCT07538674

Peiyuan Guben Tongluo Ointment for Elderly Sarcopenia

A Phase 2 study testing nutritional intervention, Exercise and Peiyuan Guben Tongluo Ointment (Ejiao concentrated) in people with Sarcopenia in Elderly, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Sarcopenia in Elderly
What is being tested?
nutritional intervention, Exercise and Peiyuan Guben Tongluo Ointment (Ejiao concentrated)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
Apr 2026to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiao ya Zhang, Undergraduate contact

+86 13645337890

2365672026@qq.com

China1 site

  • Shanghai Yueyang Integrated Medicine Hospital

    Shanghai, Shanghai Municipality, 200437

    Changpeng Han, Doctorate, 021-65161782, yueyanglcyj2019@126.com

Other trials in China

About this study

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

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.

Read the 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.

Being tested
nutritional intervention, Exercise, Peiyuan Guben Tongluo Ointment (Ejiao concentrated), Peiyuan Guben Tongluo Ointment (Agarose concentrated)
Keywords
Sarcopenia in Elderly, Deficiency of Spleen and Kidney Yin, Peiyuan Guben Tongluo Ointment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nutritional interventionDietary supplement

    Provide protein and vitamin D supplementation.

  • ExerciseBehavioural

    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 (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 (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.

Study groups in NCT07538674
Study groupRoleWhat they receive
Peiyuan Guben Tongluo Ointment (Ejiao concentrated)ExperimentalPeiyuan 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.
Receives: Dietary Supplement: nutritional intervention; Behavioral: Exercise; Drug: Peiyuan Guben Tongluo Ointment (Ejiao concentrated)
Peiyuan Guben Tongluo Ointment (Agarose concentrated)Placebo comparatorPeiyuan 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.
Receives: Dietary Supplement: nutritional intervention; Behavioral: Exercise; Drug: Peiyuan Guben Tongluo Ointment (Agarose concentrated)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, week 12, week 24

Secondary outcomes (11)

  1. Upper limb handgrip strength

    Use a hand dynamometer to record grip strength data for comparison.

    Measured: Up to 24 weeks

  2. Handgrip strength

    Use a hand dynamometer to record grip strength data for comparison.

    Measured: Baseline, week 12, week 24

  3. Timed Up and Go test (TUG)

    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.

    Measured: Baseline, week 12, week 24

  4. Berg Balance Scale (BBS)

    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.

    Measured: Baseline, week 12, week 24

  5. TCM Syndrome Score

    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.

    Measured: Baseline, week 12, week 24

  6. Peripheral blood white blood cell count

    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)

    Measured: Baseline, week 12

  7. Neutrophil count

    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)

    Measured: Baseline, week 12

  8. Interleukin-2

    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.

    Measured: Baseline, week 12

  9. Interleukin-6

    Measuring Interleukin-6 (IL-6) level, which serves as an important indicator reflecting the degree of inflammation and stress response in the body.

    Measured: Baseline, week 12

  10. Mini Nutritional Assessment (MNA)

    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.

    Measured: Baseline, week 12, week 24

  11. Activities of Daily Living (ADL) Scale

    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.

    Measured: Baseline. week 12, week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07538674
Sponsor's protocol ID
YY-PYGBTLG-001
Status last verified
Apr 2026
First submitted
6 Apr 2026
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nutritional intervention, Exercise and Peiyuan Guben Tongluo Ointment (Ejiao concentrated) in people with Sarcopenia in Elderly, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiao ya Zhang, Undergraduate (+86 13645337890, 2365672026@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DXA-measured appendicular skeletal muscle mass (time frame: Baseline, week 12, week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07538674.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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