Climacteric SyndromeNCT05846698
The Effects of Luo-Bu-Fu-Ke-Bi-RI Pill
An observational study of Climacteric Syndrome, run by Guoqing Zhou at 1 site in China.
Trial summary
To investigate the effect of LBFKBRP on climacteric syndrome in women and explore its therapeutic mechanism. Read more about this study
- Who is it for?
- Ages 41 to 60 years, women only
- Conditions the study is for
- Climacteric Syndrome
- What is being tested?
- Luo-Bu-Fu-Ke-Bi-RI Pill and tibolone
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2021to 25 Jun 2025
- Phase
- Observational
- 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 41 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: female
Clinical diagnosis of climacteric syndrome
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
To investigate the effect of LBFKBRP on climacteric syndrome in women and explore its therapeutic mechanism.
- Conditions
- Climacteric Syndrome
- Being tested
- Luo-Bu-Fu-Ke-Bi-RI Pill, tibolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luo-Bu-Fu-Ke-Bi-RI PillDrug
10 pills twice daily
tiboloneDrug
2.5 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| control group | Not described Receives: Drug: tibolone | |
| treatment group | Not described Receives: Drug: Luo-Bu-Fu-Ke-Bi-RI Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sex hormone
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start5 Sep 2021
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Climacteric SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guoqing Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guoqing Zhou, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846698
- Sponsor's protocol ID
- 2021-375
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Luo-Bu-Fu-Ke-Bi-RI Pill
- ClinicalTrials.gov ID
- NCT05846698
- Acronym / sponsor ID
- 2021-375
- Conditions
- Climacteric Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Guoqing ZhouUniversity, hospital or other
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 6 May 2023 (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.
To investigate the effect of LBFKBRP on climacteric syndrome in women and explore its therapeutic mechanism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Drug: tibolone |
| treatment group | – | Drug: Luo-Bu-Fu-Ke-Bi-RI Pill |
Who may qualify
- Ages
- 41 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- female
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 |
|---|---|---|
| Luo-Bu-Fu-Ke-Bi-RI Pill10 pills twice daily | Drug | treatment group |
| tibolone2.5 mg once daily | Drug | control group |
Primary outcome
Sex hormone
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Climacteric Syndrome, run by Guoqing Zhou 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?
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: finished, as of the sponsor's last update on 9 Sep 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sex hormone (time frame: 3 month). 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 9 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.