Ovarian AgingEarly Phase 1NCT06271928
A Multicenter Clinical Study of Yijing Keli in the Treatment of Ovarian Aging
A Early Phase 1 study testing Yijing Keli in people with Ovarian Aging, run by Tongji Hospital at 1 site in China.
Trial summary
Ovarian aging (OA) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating OA. We have created a new Chinese herbal combination Yijing Keli, whereas its safety and efficacy still need to be validated. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Ovarian Aging
- What is being tested?
- Yijing Keli
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Jan 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 diagnostic criteria for ovarian aging.
- Sign the informed consent form.
Who cannot join
- Patient is known to be allergic or unsuitable for the Chinese herbal compound.
- Women who are pregnant and lactating.
- Abnormal uterine bleeding, except ovulation disorders.
- Women is taking hormone drugs and has stopped taking them within 3 months;
- Women with endometriosis, myadenosis, submucosal fibroids or the size of non- submucosal fibroids is more than 4 cm.
- The nature of pelvic mass is unknown.
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- Women with 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 are participating in other clinical trials or have participated in other clinical trials within the last month.
- Unsuitable for the study evaluated by the investigator.
Trial locations and contacts
1 site in 1 country.
yan zhang, MD contact
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
jinjin zhang, professor, +8683663078, jinjinzhang@tjh.tjmu.edu.cn
yan zhang, MD, +8683663078
About this study
Official title: The Efficacy and Safety of Chinese Herbal Compound Yijing Keli in the Treatment of Ovarian Aging: A Multicenter and Prospective Study.
Ovarian aging (OA) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating OA. We have created a new Chinese herbal combination Yijing Keli, whereas its safety and efficacy still need to be validated. Hence, we will perform a population-based, multicenter study to confirm the safety and efficacy of Yijing Keli in therapy of OA. We aim to provide a solid evidence for TCM in therapy of OA.
- Conditions
- Ovarian Aging
- Being tested
- Yijing Keli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yijing KeliDrug
Once enrolled, participants will be administrated Yijing Keli
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Once enrolled, participants will be administrated Yijing Keli 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: Yijing Keli |
What is being measured
The primary outcome is the main question the study is designed to answer.
the recovery rate of ovarian function
evaluations of ovarian funtion are mainly based on the levels of AMH, basal serum FSH, and AFC. If the serum FSH level is lower than 10 mIU/mL, the serum AMH level is greater than 1.1 ng/mL, or AFC is more than 6 after treatment, it is considered effective. In addition, an improvement of more than 50% in these indicators after treatment can also be considered effective.
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 posted22 Feb 2024
- Study start1 Oct 2021
- Primary completion1 Jan 2024
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian AgingStudies 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, Jinjin Zhang, Tongji Hospital
- Investigators
- jinjin zhang, professor, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271928
- Sponsor's protocol ID
- TJ-IRB20220634-yijingkeli
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Chinese Herbal Compound Yijing Keli in the Treatment of Ovarian Aging: A Multicenter and Prospective Study.
- ClinicalTrials.gov ID
- NCT06271928
- Acronym / sponsor ID
- TJ-IRB20220634-yijingkeli
- Conditions
- Ovarian Aging
- 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 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 22 Feb 2024 (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.
Ovarian aging (OA) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating OA. We have created a new Chinese herbal combination Yijing Keli, whereas its safety and efficacy still need to be validated. Hence, we will perform a population-based, multicenter study to confirm the safety and efficacy of Yijing Keli in therapy of OA. We aim to provide a solid evidence for TCM in therapy of OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Yijing KeliOnce enrolled, participants will be administrated Yijing Keli 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 diagnostic criteria for ovarian aging.
- Sign the informed consent form.
Key exclusion criteria (10 listed)
- Patient is known to be allergic or unsuitable for the Chinese herbal compound.
- Women who are pregnant and lactating.
- Abnormal uterine bleeding, except ovulation disorders.
- Women is taking hormone drugs and has stopped taking them within 3 months;
- Women with endometriosis, myadenosis, submucosal fibroids or the size of non- submucosal fibroids is more than 4 cm.
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 |
|---|---|---|
| Yijing KeliOnce enrolled, participants will be administrated Yijing Keli | Drug | Treatment group |
Primary outcome
the recovery rate of ovarian function
Time frame: 6 months
evaluations of ovarian funtion are mainly based on the levels of AMH, basal serum FSH, and AFC. If the serum FSH level is lower than 10 mIU/mL, the serum AMH level is greater than 1.1 ng/mL, or AFC is more than 6 after treatment, it is considered effective. In addition, an improvement of more than 50% in these indicators after treatment can also be considered effective.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Yes
Related trials for Ovarian Aging
Enrolling by invitationObservational study
The Longitudinal Evaluation of Ovarian Aging and Cardiovascular Risk
Infertility, Cardiovascular Risk Factor
Not yet recruitingObservational study
The Bone and hEArt Health Consequences of Ovarian agiNg (BEACON) Study
Ovarian Aging, Adverse Pregnancy Outcomes
RecruitingObservational study
The ROAR Study: Reactive Oxygen Species and Reproduction
Ovarian Aging, IVF Outcome
Active, not recruiting
Ovarian Function Following Intraovarian Injection of PRP
Diminished Ovarian Reserve, Diminished Ovarian Reserve Due to Advanced Maternal Age
Active, not recruitingPhase 2
Effect of Rapamycin in Ovarian Aging
Perimenopausal
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.
yan zhang, MD contact
jinjin zhang, professor study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Yijing Keli in people with Ovarian Aging, run by Tongji Hospital at 1 site in China.
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 10 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 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact jinjin zhang, professor (+8683663078, jinjinzhang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the recovery rate of ovarian function (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 22 Feb 2024.