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

NCT ID: NCT05792813

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group

LGYY+ WZYZ mimetic

Group Type: EXPERIMENTAL

LGYY

Intervention Type: DRUG

LGYY = Linggui Yangyuan paste

WZYZ mimetic

Intervention Type: DRUG

WZYZ= Wuzi Yanzong oral solution

Control group

WZYZ + LGYY mimetic

Group Type: ACTIVE_COMPARATOR

LGYY mimetic

Intervention Type: DRUG

LGYY = Linggui Yangyuan paste

WZYZ

Intervention Type: DRUG

WZYZ= Wuzi Yanzong oral solution

Interventions

LGYY

LGYY = Linggui Yangyuan paste

Intervention Type: DRUG

LGYY mimetic

LGYY = Linggui Yangyuan paste

Intervention Type: DRUG

WZYZ

WZYZ= Wuzi Yanzong oral solution

Intervention Type: DRUG

WZYZ mimetic

WZYZ= Wuzi Yanzong oral solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The participants must meet all following criteria at the time of randomization to be eligible for recruitment :

1. Study participants met the diagnostic criteria for male infertility 1)inability to have a child after at least 1 year of marriage with regular sexual life and without using any preventive methods 2)normal fertile female partner

2. Study participants met the diagnostic criteria for AZS or OA

For AZS:

1. sperm concentration ≥15 × 106/ mL

2. PR <32%

For OA:

1. sperm concentration <15 × 106/ mL

2. PR <32% (3) Study participants met the TCM diagnosis criteria for kidney deficiency and blood stasis (4) Men aged 22 to 45 years (5) The participants signed informed consent forms

Exclusion Criteria

1. infertility is caused by the inability to complete sexual intercourse, including but not limited to erectile dysfunction or ejaculatory disorders

2. with infertility caused by organic lesions of the reproductive system

3. with reproductive system infection, such as chlamydia trachomatis or mycoplasma infection

4. with palpable varicocele

5. with abnormal and clinical significance of sex hormone (FSH, LH, T)

6. complicated with liver and kidney dysfunction, severe basic diseases such as diabetes, cardiovascular and cerebrovascular diseases, mental diseases, malignant tumors, or serious organic diseases

7. with a history of allergy to any medicine or ingredients used in this study

8. receive other relevant treatment for the disease 2 weeks before treatment

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Chengdu Fifth People's Hospital

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Nanjing University of Chinese Medicine

OTHER

Sponsor Role: collaborator

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

shengjing liu, Phd.

Role: CONTACT

liu-shengjing@qq.com

+86 01062835134

Other Identifiers

Xiyuannanke

Identifier Type: -

Identifier Source: org_study_id