A Clinical Study of Gulingji Capsule in the Treatment of Idiopathic Oligospermia, Asthenia, and Teratozoospermia

NCT05320536 | Unknown Phase 4

• 1 other identifier: Guilingji Capsule treatment
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

Brief Summary

The object of study for patients with idiopathic disease of OAT, the use of multicenter, randomized, double-blind, controlled, prospective clinical research, choose according to row, standard units of idiopathic male infertility clinics less weak abnormal sperm, randomly divided into experimental group and the placebo group, the comparison between the two groups of patients and semen parameters before and after medication, seminal plasma hormone, serum lipid levels and other indicators;At the same time, serum and seminal plasma samples of the two groups of patients before and after treatment were collected for bioinformatics analysis of protein spectrum to find the effector molecules of Gulingji capsule.

Conditions

Oligospermia

Outcome Measures

Primary Outcomes (1)

• TNPMS

  Total sperm count in forward motion

  1 years

Secondary Outcomes (1)

• DFI

  1 years

Study Arms (2)

Experimental group

EXPERIMENTAL

Guilingji capsule Take 2 tablets orally, once before breakfast and dinner, and take them with saline. The total treatment period is 90 days.

Drug: Guilingji Capsule

Control group

PLACEBO COMPARATOR

Placebo Take 2 tablets orally, once before breakfast and dinner, and take them with saline. The total treatment period is 90 days

Drug: Placebo

Interventions

Guilingji Capsule DRUG

This medicine is capsule medicine, take method is oral.

Experimental group

Placebo DRUG

This medicine is capsule medicine（Placebo）, take method is oral.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed as oligoasthenospermia according to the World Health Organization Laboratory Manual for Human Semen Examination and Treatment (5th edition);
• initial examination and reexamination of abnormal semen quality shall meet one of the following conditions: sperm density \< 15×10\^6 / mL or total sperm count \< 39×10\^6, proportion of forward motile sperm \< 32% or total sperm viability \< 40%, percentage of normal sperm \< 4%.

You may not qualify if:

• Leucospermia, with testis, epididymitis, prostatitis, severe genital trauma, testicular torsion, urinary tract infection, cryptorchidism, varicocele, and a history of serious medical conditions such as diabetes, tumor history, inguinal and genital surgery.
• Testicular volume \< 12ml (B-ultrasonic measurement).
• BMI \< 18.5 or \> 32.
• Chromosomal karyotype abnormalities.
• Patients with endocrine diseases.
• Exposure to an occupation or environment with reproductive toxicity.
• Drug therapy to improve semen quality has been used in the past 2 weeks.
• Hepatobiliary disease, severe renal insufficiency, clinical disease or history of medication known to reduce fertility.
• A known or suspected history of allergy to experimental drugs and similar products.
• Any circumstance that the investigator considers to be likely to interfere with participation in the study or assessment.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (4)

Center for Reproductive Medicine, Jinling Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Nanjing Jiangning Hospital

Nanjing, Jiangsu, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Jiangsu, China

RECRUITING

Xi 'an Tangdu Hospital

Xi’an, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Oligospermia

Interventions

guilingji

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Central Study Contacts

Yao bing

CONTACT

13815853296; yaobing@nju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The group randomization method was adopted according to the central stratification, and a total of 240 cases were randomly assigned equally to the experimental group and the control group by SAS 9.2 statistical system programming to generate a random allocation sequence table. Sequence table according to the distribution of drugs for blind packaging, medicine make blind by the personnel not to participate in clinical trials according to the generated random distribution plans and standard operating procedures for blind of experimental drugs allocation coding, coding procedure shall monitor, after completion of blind plait blind bottom seal should be in duplicate, respectively by the eastern theatre, head of the general hospital drug clinical trial institution and subject to save. SAS programs that generate randomization and related parameters are saved together with the blind end.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reproductive Medicine Center

Model Details: Blind-wrapped drugs and corresponding emergency envelopes will be distributed to each centre in serial numbers based on the number of patients assigned to each centre. Each center shall sign a drug acceptance form, signed by two people in duplicate, with the group leader and each center holding one copy. The experimental drugs are stored at room temperature, away from light and dry, and are in the charge of special personnel. Each center will distribute drugs to eligible patients starting with the minimum number.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: April 11, 2022
• Study Start: December 6, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)