Study on the clinical curative effect and mechanism of ''Jiawei Huanshao Dan'' on senile frailty syndrome

Phase 1

• Conditions: senile frailty syndrome

• Registration Number: ITMCTR2100005078
• Lead Sponsor: CHINA-JAPAN FRIENDSHIP HOSPITA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Meet the diagnostic criteria of frailty.
2. Meet the diagnostic criteria of cognitive impairment.
3. Aged >=65 years, gender is not limited.
4. Voluntary participation in research and signed informed consent.

Exclusion Criteria

1. Patients with severe cognitive impairment and limited autonomous activities who cannot complete the assessment.
2. Patients in the acute or terminal stage of the disease.
3. Patients with severe cardiovascular and cerebrovascular, digestive system, respiratory system diseases, blood diseases, and malignant tumors.
4. The treatment drugs being received affect the research such as hormones, immunosuppressants, etc.
5. Those who are allergic to the research drug or have sensitive skin.
6. Those who have participated in other clinical trials in the past 3 months.
7. Patients who are deemed unsuitable to participate in clinical trials by the investigator, including those with poor compliance determined by the investigator.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Tilburg Frailty Assessment Scale Score;Cognitive Function Assessment Scale Score;

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Scale (HAMD) Score;Daily Life Capability;The Nutritional Risk Screening (NRS 2002) Scale Score;Serum IL-6;Hamilton Anxiety Scale (HAMA) Score;Peripheral blood lymphocyte subsets;Serum TNF-a;