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Randomized controlled study on treatment of delayed hypogonadism (kidney-yang deficiency syndrome) with Guiling Ji capsule

Randomized controlled study on treatment of delayed hypogonadism (kidney-yang deficiency syndrome) with Guiling Ji capsule

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000522
Enrollment
Unknown
Registered
2025-03-13
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Late-Onset Hypogonadism

Interventions

Experimental group:Take Gulingji capsule (2 capsules/time once/day)
Control group:Placebo (2 capsules/time once/day)

Sponsors

Xiyuan Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of Western medicine for LOH (2) Conforming to the TCM syndrome differentiation standard of kidney-yang deficiency syndrome; (3) Male patients aged 40-70 years; (4) Total score of AMS questionnaire =27 (5) Voluntarily participate in this experiment and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Personal or family prostate or breast cancer patients; (2) Abnormal hematological or biochemical tests of clinical significance (anemia: hemoglobin less than 10 g/dL; Leukocytosis: leukocytes >10.0×109/L; Neutropenia: Neutrophils Absolute cell count 50%); (3) untreated endocrine diseases (hyperthyroidism or hypothyroidism Cushing syndrome etc.); (4) Diabetic patients with unstable blood glucose control fasting blood glucose = 1.5 times the upper limit of normal value or with diabetic complications (diabetic nephropathy peripheral neuropathy); (5) Patients with severe liver and kidney dysfunction defined as AST and/or ALT= normal values Limit 1.5 times; Creatinine and/or urea nitrogen = normal; (6) Patients with untreated severe sleep apnea syndrome; (7) Benign prostatic hyperplasia with severe lower urinary tract obstruction (IPSS>19 points); (8) Prostate-specific antigen (tPSA) higher than 4ng/ml; (9) History of heart failure angina pectoris myocardial infarction cerebrovascular accident and cerebral hemorrhage within the past 6 months; (10) Patients who have been treated with androgens or anabolic steroids in the past 3 months; (11) People who are allergic or allergic to known components of the test drug. Those who meet any of the above 11 criteria will meet the exclusion criteria and will not be included in this study.

Design outcomes

Primary

MeasureTime frame
aging mmales' symptoms scale;

Secondary

MeasureTime frame
Free testosterone;TCM syndrome score;Total cholesterol;international index of erectile function-5;triglyceride;Low density lipoprotein cholesterol;High density lipoprotein cholesterol;Serum testosterone;

Countries

China

Contacts

Public ContactBin Yan

Xiyuan Hospital China Academy of Chinese Medical Sciences

yanbinxyyy@126.com13718926959

Outcome results

None listed

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