A study on the clinical efficacy of Ginseng-Astragalus Delayed Failure Formula in treating frailty in the elderly

Early Phase 1

• Conditions: Frailty

• Registration Number: ITMCTR2024000197
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Meets the diagnostic criteria for Fried frailty.
(2) Comply with the diagnostic criteria of spleen qi deficiency in traditional Chinese medicine.
(3) Age 60-85 years old, gender is not limited.
(4) Volunteer subjects signed an informed consent form.
(5) The frailty patients are combined with chronic diseases, such as hypertension, diabetes mellitus, coronary heart disease, etc., and are treated with routine medication.
Physical examination and auxiliary examination show that the control is effective, can be included.
(6) Patients with malignant tumours who have been evaluated as CR (complete remission) after treatment and whose treatment has ended 3 years after enrolment.

Exclusion Criteria

(1) Patients who cannot co-operate with the assessment due to cognitive impairment, limitation of voluntary activities, etc;
(2) Patients with cardiovascular, cerebrovascular, digestive, respiratory, haematological, neurological and endocrine metabolic diseases who have been hospitalised twice in the past year.
(2) Patients with cardiovascular, cerebrovascular, digestive, respiratory, haematological, neurological and endocrine metabolic diseases who have been hospitalised twice in the past 1 year and whose conditions are often unstable;
(3) Patients with malignant tumour, whose evaluation is not CR, and who are clinically recommended for surgical/non-surgical treatment;
(4) Patients with liver and renal insufficiency, abnormal transaminases and creatinine;
(5) In addition to the above diseases, due to the combination of other diseases currently treatment can not be interrupted, or the need for repeated hospitalisation can not cooperate with the
Regular treatment;
(6) Patients participating in other clinical trials;
(7) Patients who are allergic to the drugs in this formula;
(8) Patients who are using hormone therapy for other diseases.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified