Peiyuan Guben Tongluo Ointment for Elderly Sarcopenia
ConditionSarcopenia in Elderly
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60-80
SponsorShanghai Yueyang Integrated Medicine Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 design
Treatments tested in this trial
- nutritional intervention
- Exercise
- Peiyuan Guben Tongluo Ointment (Ejiao concentrated)
- Peiyuan Guben Tongluo Ointment (Agarose concentrated)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shanghai Yueyang Integrated Medicine Hospital
Lead sponsor
Shanghai University of Traditional Chinese Medicine
Collaborator
DongE E Jiao Coporation Limited
Collaborator
Source ClinicalTrials.gov