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A multicenter, randomized, open, parallel controlled clinical trial of warming Yang and tonifying kidney (Jingui-Shenqi pill/Guifu Dihuang Pill) in the treatment of frequent urination at night in kidney-yang deficiency syndrome

A multicenter, randomized, open, parallel controlled clinical trial of warming Yang and tonifying kidney (Jingui-Shenqi pill/Guifu-Dihuang Pill) in the treatment of frequent urination at night in kidney-yang deficiency syndrome

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000279
Enrollment
Unknown
Registered
2024-08-21
Start date
2023-03-09
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

kidney yang deficiency syndrom

Interventions

Trial Group 2:Experimental medication regime combined with lifestyle guidance. The regime: Jingui-Shenqi Pill was given orally once a day, 2 pills each time. Administration time: Half an hour after di
Control group 2:Experimental medication regime combined with lifestyle guidance. The regime: Jingui-Shenqi Pill was given orally twice a day, 1 pill each time. Administration time: Half an hour after
Control group 1:Experimental medication regime combined with lifestyle guidance. The regime: Guifu-Dihuang pill was taken orally twice a day, 1 pill each time. Administration time: Half an hour after
Trial Group 1:Experimental medication regime combined with lifestyle guidance. The regime: Guifu-Dihuang pill was taken orally once a day, 2 pills each time. Administration time: Half an hour after di
Develop good sleep habits
Stay warm at night
Moderate exercise.

Sponsors

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

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) Individuals with allergic constitution (two or more allergies to drugs food or the environment) or known allergies to experimental drugs and their components; (2) Patients with acute infectious diseases (course 37.5?); (3) Subjects who received medication treatment within one week that had a clear impact on NP and were deemed unsuitable for discontinuation by the researchers (If the stabilizer dosage is maintained during the trial period participants can be included in this trial); (4) There are clear surgical indications during screening which indicates the necessity of undergoing surgical treatment in the near future by the researcher's estimate; (5) When screening the primary diseases in patients are in the acute progressive or unstable phases and the patients are not suitable for long-term treatment with investigational drugs such as urinary system tumors trauma severe sleep apnea syndrome and severe congestive heart failure causing NP; (6) Patients who have combined other serious respiratory digestive blood cardiovascular endocrine and urinary system diseases and are deemed unsuitable for treatment with the investigational drug by the researchers; (7) Patients with combined neurological and psychiatric disorders who according to the researcher's estimate find it difficult to complete self-assessment; (8) Individuals who have participated in other clinical trials within three months; (9) Patients with false fire floating syndrome symptoms include swelling and pain in the throat sores in the mouth and tongue body heat and irritability swollen and painful gums dry stools redness and lack of saliva in the tongue etc; (10) Other situations that the researchers believe are not suitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Nocturia frequency of urination;

Secondary

MeasureTime frame
Complete remission rate of nocturnal urination;nocturnal urinevolume;time to onset;

Countries

China

Contacts

Public ContactTang Jianyuan

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

tangjianyuan163@163.com+86 139 1076 8464

Outcome results

None listed

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