kidney yang deficiency syndrom
Conditions
Interventions
Trial Group 1:Guifu Dihuang pill was taken orally once a day, 2 pills each time
Control group 1:Guifu Dihuang pill was taken orally twice a day, 1 pill each time
Trial Group 2:Jinkui Shenqi Pill was given orally once a day, 2 pills each time
Control group 2:Jinkui Shenqi Pill was given orally twice a day, 1 pill each time
Sponsors
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
55 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Informed consent was obtained from the subjects or their legal guardians. (2) age 55-75 years old (including the cut-off value), regardless of gender; (3) meet the diagnostic criteria of kidney Yang deficiency syndrome of TCM; (4) Frequent nocturia at the time of screening; (5) Patients could accept lifestyle management and correctly use the smart urine meter during the study.
Exclusion criteria
Exclusion criteria: (1) those with allergic constitution or known to be allergic to the investigational drug and its components. (2) Patients with acute infectious diseases (duration 37.5?) at the time of screening. (3) Medications with definite effect on nocturia frequency within one week, including ß-adrenoceptors, a-blockers, M-blockers, synthetic antidiuretic hormone (ADH), diuretics, and traditional Chinese medicine preparations, etc. (Subjects who were judged by the investigators to be inappropriate for drug withdrawal and maintained a stable dose within one week could participate in the study). (4) Patients received benzodiazepines, non-benzodiazepine sedatives, antihistamines, antiepileptic drugs, anxiolytic drugs, sedative antidepressants and other psychotropic drugs within one week. (5) patients who had clear surgical indications at screening and needed surgical treatment in the near future according to the investigator's judgment. (6) patients with acute, progressive or unstable primary diseases at the time of screening, who were not suitable for long-term treatment with the test drug, such as nocturia caused by urinary system tumors, trauma and other factors, severe apnea syndrome, severe congestive heart failure, etc. And (7) patients with other serious respiratory, digestive, hematologic, cardiovascular, endocrine, or urologic diseases for which treatment with the trial drug, as judged by the investigator, would not be appropriate. (8) abnormal liver and kidney function tests (ALT, AST= 2 times the upper limit of normal, Scr> the upper limit of normal). (9) patients with comorbid neurological and mental disorders, which made it difficult to complete the self-assessment according to the investigator's judgment. (10) participants who participated in other clinical trials within 3 months before screening. (11) The symptoms of patients with both false fire floating during screening were sore throat, mouth and tongue sores, heat and irritability, gum swelling and pain, dry stool, red tongue and less fluid, etc. According to the above symptoms, two TCM physicians with vice-senior or above titles would simultaneously determine whether there was both false fire floating during screening. (12) other conditions that the investigator considers inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nocturia frequency of urination; | — |
Secondary
| Measure | Time frame |
|---|---|
| nocturnal urinevolume;Complete remission rate of nocturnal urination;time to onset; | — |
Countries
China
Contacts
Public ContactJianyuan Tang
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed