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A randomized parallel positive-controlled clinical study of Lingji formula for the treatment of male infertility in obese men

A randomized parallel positive-controlled clinical study of Lingji formula for the treatment of male infertility (deficiency of kidney essence and dampness in the essence chamber) in obese men

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001503
Enrollment
Unknown
Registered
2025-07-28
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Male infertility combined with obesity

Interventions

Treatment group:lingji formula

Sponsors

Xiyuan Hospital Chinese Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Meanwhile meet the western medical diagnostic criteria of male infertility and oligoasthenozoospermia and obesity; (2) Meet the traditional Chinese medicine diagnostic criteria of kidney essence deficiency and dampness in the essence chamber; (3) 22 years old = age = 45 years old; (4) Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Congenital chromosomal abnormalities or microdeletions of the Y chromosome or other known hereditary diseases that may cause sterility; or obstructive azoospermia resulting in infertility; (2) Combined with moderate to severe varicocele cryptorchidism or orchitis or epididymitis or mycoplasma or chlamydia or other diseases that clearly affect semen quality; (3) Combined with erectile dysfunction of ejaculation abnormality or other sexual dysfunctions resulting in the inability to complete intravaginal ejaculation; (4) Combined with diabetes mellitus requiring long-term medication to control blood glucose; (5) Combined with hepatic insufficiency or renal dysfunction (hepatic insufficiency defined as alanine aminotransferase and/or aspartate aminotransferase is more than 1.5 times of the upper limit of normal value and renal dysfunction defined as blood urea nitrogen and/or creatinine is more than the upper limit of normal value) or serious cardiovascular diseases or serious cerebrovascular diseases or hematopoietic system diseases or psychiatric diseases or other complications; (6) History of allergy to any drugs or ingredients used in this study; (7) Receipt of other relevant treatments for this disease such as aromatase inhibitors or estrogen antagonists etc. two weeks prior to treatment.

Design outcomes

Primary

MeasureTime frame
total progressive motile sperm count;

Secondary

MeasureTime frame
waist-to-hip ratio;Traditional Chinese medicine symptom score;sperm concentration;total cholesterol;percentage of progressive motility spermatozoa;triglyceride;pregnancy rate;percentage of normal morphology spermatozoa;body mass index;percentage of progressive motility spermatozoa plus percentage of non-progressive motility spermatozoa;semen volume;low-density lipoprotein;

Countries

China

Contacts

Public ContactGuo Jun

Xiyuan Hospital Chinese Academy of Chinese Medical Sciences

guojun1126@126.com010 62835134

Outcome results

None listed

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