Clinical study on The treatment of senile frailty syndrome by Gulingji Capsule

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000003514

Enrollment

Unknown

Registered

2020-07-26

Start date

2020-08-01

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Senile asthenia syndrome

Interventions

Experimental group:Oral administration: 0.6g (2 tablets) once a day, 2 hours before breakfast with light saline.

Eligibility

Sex/Gender

All

Age

65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Frailty scale assessment;	—

Secondary

Measure	Time frame
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;	—

Countries

China

Contacts

Public ContactYefeng Cai

Guangdong Provincial Hospital of Traditional Chinese Medicine

124890119@qq.com+86 13631333842

Outcome results

None listed

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