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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-06

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Oligospermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Guilingji Capsule

Intervention Type DRUG

This medicine is capsule medicine, take method is oral.

Control group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Guilingji Capsule

This medicine is capsule medicine, take method is oral.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No