Ancient herb mix may soothe menopause discomfort
NCT ID NCT07160127
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 113 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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45 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a gel ease menopause symptoms that disrupt daily life?
- Blue light could soothe vaginal disorders without hormones
- Breast cancer survivors face hidden menopause burden
- Menopause symptom study pulled before enrolling a single patient
- Laser therapy offers hope for cancer survivors with menopause symptoms
- Could radio waves ease menopause symptoms? new trial investigates