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Clinical study on the efficacy and safety of Jin-Tian-Ge capsule in the treatment of sarcopenia

Clinical study on the efficacy and safety of Jin-Tian-Ge capsule in the treatment of sarcopenia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075997
Enrollment
Unknown
Registered
2023-09-21
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Interventions

Treatment group:Treatment with Jin-Tian-Ge capsule
Control group:Treatment with the simulant of Jin-Tian-Ge capsule, which is composed of starch+caramel

Sponsors

Xi’an Honghui Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Diagnosed with sarcopenia according to "Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment". (2) Age =50 years old, gender is not limited. (3) Voluntarily subjected to the test and signed an informed consent form. (4) BMD > -2.5 SD in lumbar vertebrae (L1-L4) and hip.

Exclusion criteria

Exclusion criteria: (1) Major diseases that may affect the results of the present study: ? Rheumatic immune system diseases: rheumatoid arthritis, systemic lupus erythematosus; ? Endocrine system diseases: hyper/hypothyroidism, diabetes mellitus; ? Severe cardiovascular system diseases: hypertension grade 2 or above, myocardial infarction, congenital heart disease, cardiac insufficiency, after cardiac surgery; ? Neurological system diseases: myasthenia gravis, periodic paralysis, polymyositis, dermatomyositis, Parkinson's syndrome and stroke and other causes of paralysis; ? Hematological system diseases: immune thrombocytopenia (platelets <90X10E9/L), moderately severe anemia (HGB <90g/L); ? Combined respiratory, gastrointestinal, urinary and other major system diseases; (vii) Serious liver and kidney function serious abnormalities caused by various reasons, AST/ALT greater than 1.5 times the upper limit of normal value; ? Serious infectious diseases of various organs; ? Combined with diseases that affect BMD and calcium and phosphorus metabolism; ? Various malignant tumors; (2) The use of traditional Chinese medicine in the past month and the use of drugs affecting bone and muscle metabolism in the past six months (bisphosphonates, estrogens, calcitonin, vitamin D, teriparatide, disulfiram, etc.); (3) Previous history of allergy to proprietary Chinese medicines; (4) Patients who are illiterate, suffering from mental illness, dementia who cannot cooperate to complete the clinical study; (5) Patients who are too obese to undergo bone mineral density examination and body composition analysis; (6) Participating in other clinical studies at the same time.

Design outcomes

Primary

MeasureTime frame
Skeletal muscle mass index;Muscle strength (grip strength);Somatic function (testing 6m step speed, 5 sit-up test, SPPB score);ADL Rating Scale for Activities of Daily Living, SARC-CalF Scale;

Secondary

MeasureTime frame
Serum biochemical indicators (ALP?25OHD?PTH?CTX?P1NP?Ga?Pi?CK?CKMB);Fall risk;bone mineral density;Anthropometric indicators: height, weight, waist, hip, calf circumference;

Countries

China

Contacts

Public ContactYuhong Zeng

Xi’an Honghui Hospital

xahhzyh@163.com+86 135 7183 3516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026