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Ancient herbal tonic put to the test for male fertility

NCT ID NCT07270146

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 4 trial tested whether Guilu Erxian Oral Liquid, a traditional Chinese herbal remedy, can improve sperm count and movement in men with mild to moderate low sperm count or poor sperm motility. The study enrolled 360 married men aged 22 to 40 who also had a diagnosis of kidney essence deficiency. Participants received either the herbal liquid or a standard comparator, and researchers measured changes in total motile sperm count and other semen parameters.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Guilu Erxian Oral Liquid (a traditional Chinese herbal remedy)
What this could lead to
If it works, this could offer a treatment option for men with low sperm count or poor sperm movement related to kidney essence deficiency.
What could go wrong
This is a Phase 4 trial, but results are not yet published. The condition is subjective and the herbal remedy may not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

360 people

The number who actually took part.

Started

Oct 2022

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 40 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Married men aged 22 to 40; 2. Meet the diagnostic criteria of male infertility; 3. Meet the diagnostic criteria for mild and moderate oligozoospermia, asthenospermia and oligoasthenospermia; 4. Meet the TCM syndrome differentiation standard of Shen (kidney) essence deficiency syndrome; 5. Sign the informed consent form voluntarily. Exclusion Criteria: 1. Infertility due to chromosome abnormalities (such as Roche heterotopia, Y chromosome microdeletion, etc.); 2. Varicocele or cryptorchidism; 3. Diseases affecting semen quality such as orchitis, epididymitis, mycoplasma and chlamydia infection; 4. Anejaculation, retrograde ejaculation and other sexual dysfunction; 5. Severe liver and kidney dysfunction (alanine aminotransferase (ALT)\>1.5 × ULN, aspartate aminotransferase (AST)\>1.5 × ULN, blood urea nitrogen (BUN)\>2 × ULN, Cr\>1 × ULN), disease of cardiovascular and cerebrovascular system, disease of hematopoietic system; 6. Hypertension (systolic blood pressure \> 160 mmHg and / or diastolic blood pressure \> 100 mmHg) or diabetes (fasting blood glucose \> 7mmol / L) with poor drug control; 7. Serious mental illness, accompanied by mental disorder or loss of self-care ability; 8. Those who are allergic to the test drug; 9. Those who have long term bad habits such as smoking and drinking, which may affect fertility, or those who cannot ban smoking and drinking during the test, the specific criteria are as follows: ①History of smoking: Those who have smoked more than 5 cigarettes per day in the past 6 months; ②History of drinking: in the past 6 months, the average daily consumption of alcohol exceeded the following standards: 570 ml of beer, 200 ml of wine or 60 ml of spirit, each containing about 20 g of alcohol; 10. Those who have been unable to take the test drug in the past or have intolerable adverse reactions; 11. Those who used drugs to improve or affect sperm concentration or motility 1 month before screening; 12. Those who have participated in other clinical trials within 3 months before screening; 13. According to the judgment of the investigator, there are other persons who are not suitable to participate in this clinical trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Xi Yuan Hospital of China Academy of Chinese Medical Sciences

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.