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A Randomized Controlled Clinical Trial (RCT) on the Efficacy and Safety of Shenzhu YiJing Formula in the Treatment of Obesity-Related Infertility (Spleen-Qi Deficiency and Dampness Accumulation Syndrome)

Clinical Observation on the Treatment of Obesity-Related Infertility (Spleen-Deficiency and Dampness-Excess Syndrome) with Shenzhu Yijing Formula

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000847
Enrollment
Unknown
Registered
2025-04-25
Start date
2021-11-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

male infertility

Interventions

Trial Group:Shenzhu Yijing Formula

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Age between 22 and 45 years old; (2) Meets the diagnostic criteria for male infertility and obesity based on Western medicine;(3) Meets the Chinese medicine diagnostic criteria for Spleen Deficiency with Dampness;(4) Voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Spouses with gynecological diseases that cannot be excluded with disadvantage in fertility or diagnosed with infertility disorders; Patients with decreased semen quality and erectile dysfunction due to hereditary infectious or anatomical malformations. (2) patients with severe cardiovascular and cerebrovascular diseases severe renal and/or hepatic injury severe mental disorders hematological disease and other serious complications; (3) patients who were allergic to any drug used in the study; and (4) patients who participated in other clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
Progressive Motility;sperm concentration;

Secondary

MeasureTime frame
BMI;Natural conception rate;TCM evidence score;

Countries

China

Contacts

Public ContactJun Guo

Xiyuan Hospital of China Academy of Chinese Medical Sciences

guojun11126@126.com13911272060

Outcome results

None listed

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