Clinical study on The treatment of senile frailty syndrome by Gulingji Capsule
- Conditions
- Senile asthenia syndrome
- Registration Number
- ITMCTR2000003514
- Lead Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Aged 65-85 years (including boundary value);
2. Survival >= 6 months;
3. It conforms to the indications of senile frailty syndrome, and refers to the definition of frailty standard by Fried et al.;
4. Those who conform to traditional Chinese medicine kidney-yang deficiency;
5. No impairment of comprehension, hearing or vision, can perform general commands, can communicate normally and can complete physical assessment tests;
6. No vestibular or cerebellar dysfunction, can walk independently without assistance;
7. Patients who signed informed consent after informed consent and volunteered to participate in this study.
1. Patients with acute or severe malignant chronic diseases in the elderly, such as patients with acute onset of chronic obstructive pulmonary disease, acute coronary syndrome, Parkinson's disease, depression, tuberculosis and malignant tumors;
2. New York Heart Association (NYHA) grade III to IV;
3. Patients with severe musculoskeletal diseases;
4. Those who have taken traditional Chinese medicine for tonifying kidney-yang in the past month or are taking hormones;
5. Completely bedridden or unable to exercise;
6. Allergic constitution or allergic to known ingredients of this drug;
7. Participating in other intervention tests;
8. The investigator considers it inappropriate to participate in this clinical study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frailty scale assessment;
- Secondary Outcome Measures
Name Time Method Sleep quality score;Clinical frailty scale score;Incidence of adverse events;TCM syndrome score;Daily Life Activity Scale score;Micronutrition Assessment Score;Serum transferrin, Vitamin B12, vitamin D, thyrotropin, superoxide dismutase, interleukin6, sex hormone 6 tests;Simple Intelligence scale score;