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

A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study of Gulingji Capsule in the Treatment of Idiopathic Oligospermia, Asthenia, and Teratozoospermia.

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.

Study Overview

• Status: Recruiting
• Conditions: Oligospermia
• Intervention / Treatment: Drug: Guilingji Capsule; Drug: Placebo

Detailed Description

The WHO defines infertility as a condition in which a couple cohabitates and has normal sex, has not used contraception for more than a year and the woman has not been able to conceive naturally.Some male infertility patients who cannot find related infertility factors are called idiopathic male infertility.These male infertility patients are often characterized by abnormal sperm count (including oligospermia, azoospermia, occult sperm), abnormal motility (including asthenospermia, asthenospermia), or malformed sperm, collectively referred to as idiopathic oligospermia (idiopathic OAT).

At present, the treatment methods of idiopathic OAT are mostly empirical treatment, including anti-oxidation treatment, treatment to improve cell energy metabolism, treatment to improve microcirculation of the whole body and reproductive system, etc.In general, traditional Chinese treatment should be combined with traditional Chinese medicine.However, the relevant mechanism of TCM treatment of OAT is not yet clear.

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.

It is assumed that the probable case loss rate in the trial is 20%, with 120 cases in each group, and a total of 240 cases are required.

Drug treatment: Gulingji capsule was taken orally for 2 capsules, once before breakfast and dinner, and was taken with saline solution. The total treatment period was 90 days.(Placebo is rice flour)

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yao bing; Phone Number: 13815853296; Email: yaobing@nju.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Center for Reproductive Medicine, Jinling Hospital
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing Jiangning Hospital
      • Contact: Tang Qinlai
    • Wenzhou, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
      • Contact: Pan Chengshuang
    • Xi'an, Jiangsu, China
      • Recruiting
      • Xi 'an Tangdu Hospital
      • Contact: Li Jianbo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Diagnosed as oligoasthenospermia according to the World Health Organization Laboratory Manual for Human Semen Examination and Treatment (5th edition);
2. 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%.

Exclusion Criteria:

1. 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.
2. Testicular volume < 12ml (B-ultrasonic measurement).
3. BMI < 18.5 or > 32.
4. Chromosomal karyotype abnormalities.
5. Patients with endocrine diseases.
6. Exposure to an occupation or environment with reproductive toxicity.
7. Drug therapy to improve semen quality has been used in the past 2 weeks.
8. Hepatobiliary disease, severe renal insufficiency, clinical disease or history of medication known to reduce fertility.
9. A known or suspected history of allergy to experimental drugs and similar products.
10. Any circumstance that the investigator considers to be likely to interfere with participation in the study or assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; This medicine is capsule medicine, take method is oral.
Placebo Comparator: Control group; Placebo Take 2 tablets orally, once before breakfast and dinner, and take them with saline. The total treatment period is 90 days	Drug: Placebo; This medicine is capsule medicine（Placebo）, take method is oral.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TNPMS	Total sperm count in forward motion	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFI	Sperm DNA fragmentation rate	1 years

Collaborators and Investigators

• Sponsor: Jinling Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: April 2, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 2, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility, Male; Infertility; Asthenia; Oligospermia; Teratozoospermia
• Other Study ID Numbers: Guilingji Capsule treatment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No