NCT05792813

Efficacy and Safety of Linggui Yangyuan Paste in Patients With Male Infertility

Xiyuan Hospital of China Academy of Chinese Medical Sciences

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: Male
• Age: 22 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Male infertility affects millions of males worldwide and is rising in prevalence due to social and environmental conditions. Asthenozoospermia (AZS) and oligoasthenozoospermia (OA) are the major causes of male infertility. The diagnosis of male infertility has a negative effect on men's physical and psychological status, poses a threat to their social relationships, lowers self-esteem, and disrupts family harmony. At present, the treatment of ASZ and OA are all mostly empirical, including antioxidants, endocrine therapy, and anti-infection. However, there are still limitations due to inefficiencies. Linggui Yangyuan paste (LGYY), a traditional Chinese compound herbal past, had been used to treat ASZ and OA for several years at the Xiyuan Hospital of China Academy of Chinese Medical Sciences. The investigators designed this program to study the efficacy and safety of LGYY for the treatment of patients with male infertility (AZS and OA).

Conditions

• Male Infertility
• Asthenozoospermia
• Oligoasthenozoospermia

Interventions

Type	Name	Description
DRUG	LGYY	LGYY = Linggui Yangyuan paste
DRUG	LGYY mimetic	LGYY = Linggui Yangyuan paste
DRUG	WZYZ	WZYZ= Wuzi Yanzong oral solution
DRUG	WZYZ mimetic	WZYZ= Wuzi Yanzong oral solution

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2023-03-31
• Last updated: 2023-04-27