Menopausal SyndromeEarly Phase 1NCT05522621
A Muticenter Clinical Study of Chinese Herbal Compound TJAOA102 in Alleviating Menopausal Syndrome
A Early Phase 1 study testing TJAOA102 in people with Menopausal Syndrome, run by Tongji Hospital.
Trial summary
Currently, TCM recipes are widely used in treating menopausal syndrome(MS) with obvious efficiency and slight side effects. We have developed the Chinese herbal compound TJAOA102 and has validated its effects in animals. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Menopausal Syndrome
- What is being tested?
- TJAOA102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Oct 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The age range of patient is 18-55 years old.
- The diagnosis of women is DOR, POI, early menopause or menopausal syndrome, and wish to improve ovarian function or menopausal syndrome.
- Sign the informed consent form.
Who cannot join
- The patient is known to be allergic or unsuitable for the Chinese herbal compound. (2) Women who are pregnant and lactating.
- Patients of POI or DOR had been menopause for more than 1 year. (4) Abnormal uterine bleeding, except ovulation disorders. (5) Women who is taking hormone drugs and has stopped taking them within 3 months; (6) The diagnosis of women is endometriosis, myadenosis, submucosal fibroids or the size of non-submucosal fibroids is more than 4 cm.
- The nature of pelvic mass is unknown. (8) The diagnosis of women is polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, diabetes, thyroid and adrenal dysfunction and other endocrine diseases affecting ovulation.
- Patients with serious primary diseases such as cardiovascular, liver, kidney, lung, biliary, hematopoietic system (Hb<90g/L) and malignant tumor, and psychiatric patients.
- Patients who are participating in other clinical trials or have participated in other clinical trials within the last month.
- Patients who are unsuitable for the study evaluated by the investigator.
About this study
Official title: The Efficacy and Safety of Chinese Herbal Compound TJAOA102 in the Treatment of Menopausal Syndrome: A Multicenter, Prospective and Before-after Study.
Currently, TCM recipes are widely used in treating menopausal syndrome(MS) with obvious efficiency and slight side effects. We have developed the Chinese herbal compound TJAOA102 and has validated its effects in animals. Here, we will perform a population-based, multicenter study to confirm the safety and efficacy of TJAOA102 in therapy of MS, which will provide a solid evidence for TCM in therapy of MS.
Read the detailed description
Early menopause which is caused by DOR and POI may accelerate the aging of women, and lead to osteoporosis, cardiovascular and cerebrovascular diseases, frequent urination, dysuria, and decreased sleep quality. Postmenopausal women may suffer from osteoporosis and atherosclerosis, coronary heart disease and high blood pressure due to elevated cholesterol, triglycerides and low-density lipoproteins. Hence, the intervention for MS is indispensable. Currently, hormonotherapy(HT) is the first-line drug therapy recommended by clinical treatment guidelines. It can add exogenous sex hormones by replenishing the lack of hormones to relieve the symptoms caused by ovarian function decline, and then improve the health and life quality.However, HT also increased the risk of breast cancer, phlebothrombosis and so on. Hence, besides HT, TCM is an effective and alternative option.
To address this question, firstly we screened the database from the perspective of western medicine to identify the candidate Chinese herbs. Then multiple model organisms were used to verify their safety and effectiveness. Next, from the view of TCM, the pharmacological action, dose, synergistic effect and incompatibility were determined and finally TJAOA102, a Chinese medicine recipe for anti-ovarian aging was created. The essence of menopause is ovarian aging, so we developed anti-ovarian aging formula-TJAOA102.
At present, there is no guideline for long-term TCM management in treating MS. A clinical trial is imperative to test the safety and efficacy of TCM prescription. This study is a multicenter and prospective trial aiming to determine the safety and efficacy of TJAOA102 for preventing among women who were diagnosed with MS.
- Conditions
- Menopausal Syndrome
- Being tested
- TJAOA102
- Keywords
- Menopausal Syndrome, Traditional Chinese Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJAOA102Drug
Once enrolled, participants will be administrated TJAOA102
| Study group | Role | What they receive |
|---|---|---|
| TJAOA102 | Experimental | Once enrolled, participants will be administrated TJAOA102 and followed by a 3-month medication cycle. The usage of this herbal compound is to take orally twice a day(two sacks per). Add it to about 200ml warm water and take it half an hour before breakfast in the morning and half an hour before bedtime in the evening except menstrual period. Receives: Drug: TJAOA102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the change of Kupperman Index Score（KMI）
Assessing the KMI before and after the treatment of TJAOA102
Measured: 6 months
Secondary outcomes (1)
recovery rate of ovarian function
the recovery of ovarian function is defined as serum AMH increased more than 50%, or serum bFSH decreased more than 50%, or antral follicle count(AFC) increased more than 50% compared with that before treatment，or recover to normal level.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal SyndromeStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shixuan Wang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522621
- Sponsor's protocol ID
- TJ-IRB20220634-MS
- Status last verified
- Aug 2022
- First submitted
- 29 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Chinese Herbal Compound TJAOA102 in the Treatment of Menopausal Syndrome: A Multicenter, Prospective and Before-after Study.
- ClinicalTrials.gov ID
- NCT05522621
- Acronym / sponsor ID
- TJ-IRB20220634-MS
- Conditions
- Menopausal Syndrome
- Keywords
- Menopausal Syndrome, Traditional Chinese Medicine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, TCM recipes are widely used in treating menopausal syndrome(MS) with obvious efficiency and slight side effects. We have developed the Chinese herbal compound TJAOA102 and has validated its effects in animals. Here, we will perform a population-based, multicenter study to confirm the safety and efficacy of TJAOA102 in therapy of MS, which will provide a solid evidence for TCM in therapy of MS.
Detailed description
Early menopause which is caused by DOR and POI may accelerate the aging of women, and lead to osteoporosis, cardiovascular and cerebrovascular diseases, frequent urination, dysuria, and decreased sleep quality. Postmenopausal women may suffer from osteoporosis and atherosclerosis, coronary heart disease and high blood pressure due to elevated cholesterol, triglycerides and low-density lipoproteins. Hence, the intervention for MS is indispensable. Currently, hormonotherapy(HT) is the first-line drug therapy recommended by clinical treatment guidelines. It can add exogenous sex hormones by replenishing the lack of hormones to relieve the symptoms caused by ovarian function decline, and then improve the health and life quality.However, HT also increased the risk of breast cancer, phlebothrombosis and so on. Hence, besides HT, TCM is an effective and alternative option.
To address this question, firstly we screened the database from the perspective of western medicine to identify the candidate Chinese herbs. Then multiple model organisms were used to verify their safety and effectiveness. Next, from the view of TCM, the pharmacological action, dose, synergistic effect and incompatibility were determined and finally TJAOA102, a Chinese medicine recipe for anti-ovarian aging was created. The essence of menopause is ovarian aging, so we developed anti-ovarian aging formula-TJAOA102.
At present, there is no guideline for long-term TCM management in treating MS. A clinical trial is imperative to test the safety and efficacy of TCM prescription. This study is a multicenter and prospective trial aiming to determine the safety and efficacy of TJAOA102 for preventing among women who were diagnosed with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TJAOA102 | Experimental | Drug: TJAOA102Once enrolled, participants will be administrated TJAOA102 and followed by a 3-month medication cycle. The usage of this herbal compound is to take orally twice a day(two sacks per). Add it to about 200ml warm water and take it half an hour before breakfast in the morning and half an hour before bedtime in the evening except menstrual period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The age range of patient is 18-55 years old.
- The diagnosis of women is DOR, POI, early menopause or menopausal syndrome, and wish to improve ovarian function or menopausal syndrome.
- Sign the informed consent form.
Key exclusion criteria (6 listed)
- The patient is known to be allergic or unsuitable for the Chinese herbal compound. (2) Women who are pregnant and lactating.
- Patients of POI or DOR had been menopause for more than 1 year. (4) Abnormal uterine bleeding, except ovulation disorders. (5) Women who is taking hormone drugs and has stopped taking them within 3 months; (6) The diagnosis of women is endometriosis, myadenosis, submucosal fibroids or the size of non-submucosal fibroids is more than 4 cm.
- The nature of pelvic mass is unknown. (8) The diagnosis of women is polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, diabetes, thyroid and adrenal dysfunction and other endocrine diseases affecting ovulation.
- Patients with serious primary diseases such as cardiovascular, liver, kidney, lung, biliary, hematopoietic system (Hb<90g/L) and malignant tumor, and psychiatric patients.
- Patients who are participating in other clinical trials or have participated in other clinical trials within the last month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TJAOA102Once enrolled, participants will be administrated TJAOA102 | Drug | TJAOA102 |
Primary outcome
Evaluating the change of Kupperman Index Score（KMI）
Time frame: 6 months
Assessing the KMI before and after the treatment of TJAOA102
1 secondary outcome
recovery rate of ovarian function
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TJAOA102 in people with Menopausal Syndrome, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the change of Kupperman Index Score（KMI） (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.