A Clinical Study of Chinese Herbal Formula TJAOA103 in Treating Genitourinary Syndrome of Menopause
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age45-70
SponsorTongji Hospital
About this trial
The goal of this clinical trial is to learn if Chinese herbal formula TJAOA103 works to treat genitourinary syndrome of menopause (GSM). It will also learn about the safety of TJAOA103. The main questions it aims to answer are:
1. Does TJAOA103 alleviate the symptoms of GSM in participants or have any other benefits? 2. What medical problems do participants have when taking TJAOA103? Researchers will conduct a pre-post comparison to see if TJAOA103 works to treat GSM.
Participants will:
1. Take TJAOA103 twice daily for 4 to 12 weeks. 2. Complete the tests and/or questionnaires on schedule through online follow-up or outpatient visits. 3. Record their use of TJAOA103 and any adverse events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females aged 45-70 years during the menopausal transition or postmenopausal period.
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.
Willing to participate in this trial and sign a written informed consent form.
Disqualifiers
Acute or recurrent genitourinary infection.
Acute or chronic dermatosis of the vulva or vagina.
A grade 3 or higher degree of prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
Unexplained abnormal uterine bleeding.
Trial design
Design model
Single group
Treatments tested in this trial
TJAOA103
DrugOnce enrolled, participants will be administered TJAOA103 for 4 to 12 weeks. TJAOA103 should be taken orally twice a day, one sack each time. Dissolve it in about 200 mL of warm water and drink it all. Participants can take it half an hour before breakfast in the morning and half an hour before bedtime in the evening.
Treatment groups
113 Participants
are divided into 1 treatment groupGroup A: TJAOA103Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
severity of the most bothersome symptom (MBS)
The MBS is derived from a selected list of common GSM symptoms, including vulvovaginal dryness, vulvovaginal itching/irritation, vulvovaginal burning/pain, dyspareunia, and dysuria/urinary frequency/urgency. At baseline, participants will be instructed to rate the severity of each symptom as absent (0), mild (1), moderate (2), or severe (3). They will then be asked to select a single MBS among those symptoms they classify as moderate or severe (i.e., a score ≥ 2). The MBS will be tracked through to the end of treatment, and the changes in its severity will be used to assess symptomatic improvement.
Time frame
From enrollment to the end of treatment at 4 or 12 weeksSecondary outcomes
1
total score of GSM symptoms
The total score, which ranges from 2 to 15, is the sum of the five individual symptom scores. The higher the score, the more severe the GSM symptoms are.
Time frame
From enrollment to the end of treatment at 4 or 12 weeks2
score for a specific GSM symptom
The self-assessed severity score for a specific GSM symptom is assigned as 0, 1, 2, or 3 points, corresponding respectively to absent, mild, moderate, and severe.
Time frame
From enrollment to the end of treatment at 4 or 12 weeks3
Vaginal Health Index Score (VHIS)
The total score of VHIS ranges from 5 to 25. The lower the score, the worse the vaginal health condition.
Time frame
From enrollment to the end of treatment at 4 or 12 weeks4
vaginal pH
A pH level of 4.6 or above indicates vaginal atrophy.
Time frame
From enrollment to the end of treatment at 4 or 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: