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

Sponsor

Jinling Hospital, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT05320536

Collaborator

(none)

240

Enrollment

Locations

Arms

12.8

Anticipated Duration (Months)

Patients Per Site

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oligospermia	Drug: Guilingji Capsule Drug: Placebo	Phase 4

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.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 6, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

TNPMS [1 years]
Total sperm count in forward motion

Secondary Outcome Measures

DFI [1 years]
Sperm DNA fragmentation rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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%.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Reproductive Medicine, Jinling Hospital	Nanjing	Jiangsu	China	210000
2	Nanjing Jiangning Hospital	Nanjing	Jiangsu	China
3	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Jiangsu	China
4	Xi 'an Tangdu Hospital	Xi'an	Jiangsu	China

Sponsors and Collaborators

Jinling Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jan 1, 2021

More Information

Publications

None provided.

Responsible Party:

Bing Yao, Reproductive Medicine Center, Jinling Hospital, China

ClinicalTrials.gov Identifier:

NCT05320536

Other Study ID Numbers:

Guilingji Capsule treatment

First Posted:

Apr 11, 2022

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Oligospermia

Teratozoospermia

Asthenia

Study Results

No Results Posted as of Apr 11, 2022