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

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

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

Sponsors & Collaborators

• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

  collaborator OTHER

• Shandong University of Traditional Chinese Medicine

  collaborator OTHER

• Chengdu Fifth People's Hospital

  collaborator OTHER

• Affiliated Hospital of Nanjing University of Chinese Medicine

  collaborator OTHER

• Xiyuan Hospital of China Academy of Chinese Medical Sciences

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-30

Primary Completion

2024-06-30

Completion

2024-12-31