Frailty in the Elderly
Conditions
Interventions
experimental group:Sanqi Shenfeng Oral Liquid, for oral use. Take 10 ml each time, 3 times a day.
Sponsors
The First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 60 to 80 years, gender not specified 2.Meet the criteria for pre-frailty or frailty according to the Fried Frailty Phenotype (satisfy one or more of the following five items) :(1) Unexplained weight loss; (2) Fatigue; (3) Decreased grip strength; (4) Slowed walking speed; (5) low physical activity. 3.Clear consciousness, with the ability to understand, respond, and act independently, or able to complete the questionnaire with the assistance of family members 4.Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with dysphagia; 2.Patients with acute infections or inflammations such as upper respiratory tract infection and/or those with a body temperature of >= 37.5?; 3.End-stage disease or acute clinical event (without judging stability) a. Advanced cancer; b. Significant laboratory index abnormalities: total bilirubin >1.5×ULN, ALT/AST >2.5×ULN, Scr >1.5×ULN, or platelet 5% in the past 90 days or the need for parenteral or enteral nutrition support); e. Chronic heart failure, New York Heart Association (NYHA) class III-IV; f. Chronic kidney disease stage 3b-5 [estimated glomerular filtration rate eGFR equivalent to metoprolol 100 mg/ day), central antihypertensive agents (e.g., clonidine, methyldopa), and loop diuretics (doses > equivalent to furosemide 40 mg/ day). Exception: Patients were allowed to participate in the trial if they had been using these drugs for at least 4 weeks at a stable dose that, in the judgment of the investigator, did not affect the efficacy and safety evaluation. 7.A history of alcohol or drug abuse; 8.Patients were enrolled in other intervention studies at the same time or within three months before screening. 9.Patients allergic to the trial drug and its excipients, indocyanine green, iodine, iodide, or other iodine-containing preparations; 10. Any other significant abnormality that the investigator considered might preclude the smooth conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in total score of the Fried Frailty Phenotype Scale after treatment.;Change from baseline in in 6-minute walk test (m) after treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Pittsburgh Sleep Quality Index (PSQI) total score after treatment.;Change from baseline in appendicular skeletal muscle index (kg·m^-2) after treatment. ;Change from baseline in grip strength (kg) after treatment.;Change from baseline in 5 repeated sit-to-stand test (s) after treatment.;Change from baseline in liver reserve function (ICG plasma clearance rate, ICG retention rate at 15 minutes, effective hepatic blood flow, effective hepatic blood flow index, and blood oxygen saturati;Change from baseline in fatty liver and liver fibrosis [controlled attenuation parameter of liver steatosis (CAP, dB/m), liver stiffness elasticity (E, kPa)] after treatment;Scale Questionnaire: Changes in the total score of the Short Physical Performance Battery (SPPB), score of the 36-Item Short Form Health Survey (SF-36), total score of the Mini Nutritional Assessment Short Form (MNA-SF), and total score of the SARC-CalF questionnaire for sarcopenia screening from baseline after treatment.; | — |
Countries
China
Contacts
Public ContactHongju Yang
The First Affiliated Hospital of Kunming Medical University
Outcome results
None listed