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Ancient herb mix may soothe menopause discomfort

NCT ID NCT07160127

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-phase trial will test whether a Chinese herbal formula called TJAOA103 can relieve genitourinary symptoms of menopause, such as vaginal dryness, itching, and pain during sex. About 113 women aged 45-70 will take the herbal drink twice daily for 4 to 12 weeks. Researchers will track symptom changes and any side effects to see if the treatment is safe and helpful.

What this could mean

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

Active substance
Chinese herbal formula TJAOA103
What this could lead to
If it works, this could offer a non-hormonal option to ease uncomfortable menopause symptoms like vaginal dryness and pain.
What could go wrong
This is a very early, small study with no placebo group, so results may not be reliable. The herbal formula may not work or could cause side effects.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 113 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

45 to 70 years

Sex

Female 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. Females aged 45-70 years during the menopausal transition or postmenopausal period. 2. Presence of at least one moderate-to-severe (score ≥ 2) symptom of GSM, including vulvovaginal dryness, or vulvovaginal itching/irritation, or vulvovaginal burning/pain, or dyspareunia, or dysuria/urinary frequency/urgency. 3. Willing to participate in this trial and sign a written informed consent form. Exclusion Criteria: 1. Acute or recurrent genitourinary infection. 2. Acute or chronic dermatosis of the vulva or vagina. 3. A grade 3 or higher degree of prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system. 4. Unexplained abnormal uterine bleeding. 5. Ovarian/adnexal mass ≥ 4 cm, or adenomyosis, or adenomyoma/uterine myoma ≥ 4 cm. 6. Breast Imaging Reporting and Data System (BI-RADS) classification of breast ultrasound ≥ 4. 7. Presence of precancerous lesions or diagnosed malignancy. 8. Liver or kidney function indicators (ALT, AST, Urea, Cr) exceeding the upper limits of reference ranges upon repeated testing. 9. Severe primary diseases of the nervous, circulatory, respiratory, digestive, urinary or hematopoietic systems; or mental diseases; 10. Known allergy to any specific ingredient of the trial drugs. 11. Systemic hormone therapy within the past 2 months. 12. Application of vaginal moisturizers, lubricants, hormone preparations, or alternative therapies for GSM within the past month. 13. Current participation in another clinical trial or participation in another trial within the past month. 14. Unwillingness to discontinue the use of moisturizers, lubricants, or any form of hormonal drugs during the trial. 15. Other conditions deemed unsuitable for participation by the investigators.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, China

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