Postmenopausal OsteoporosesEarly Phase 1CSOPOPWXJGNCT03563235
Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules
A Early Phase 1 study testing Xulin Jiangu granules and Calcitriol capsules in people with Postmenopausal Osteoporoses, run by Fujian Academy of Traditional Chinese Medicine at 1 site in China.
Trial summary
Osteoporosis is a common senile disease with a high incidence. The Chinese medicine differentiation treatment has small side effects and can be taken for a long time, which has certain advantages. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporoses
- What is being tested?
- Xulin Jiangu granules and Calcitriol capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 31 Dec 2021
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 2 years prior and met the diagnostic criteria for osteoporosis according to the "clinical practice guidelines of traditional medicine for primary osteoporosis
- met the CM diagnostic criteria according to "Syndrome Differentiation in Modern Research of Traditional Chinese Medicine
Who cannot join
- patients who did not meet the diagnostic criteria for osteoporosis or CM standards
- patients with rheumatoid arthritis, diabetes, secondary osteoporosis due to hyperthyroidism, and severe cardiovascular or cerebrovascular diseases
- patients with abnormal liver and/or Shen function test results
- patients with osteoporosis who had received treatment with CM within the last month, hormone replacement therapy and calcitonin within the past three months, or bisphosphonates for 15 consecutive days within the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Osteoporosis is a common senile disease with a high incidence. The Chinese medicine differentiation treatment has small side effects and can be taken for a long time, which has certain advantages. This project adopts the experience of the person in charge of the project-Xulin Jiangu Granules and clinically collects patients with postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome).
Read the detailed description
Randomized control method was used to observe the clinical efficacy of the treatment of postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome) with jiujian jiangu granules, combined with the gene expression of bone metabolism markers BALP, PINP, TRACP and S-CTX, and RANK, RANKL and OPG Detection, compared with the control group of ossification trihydrate capsules, to explore the mechanism of the treatment of postmenopausal osteoporosis by the continued Xulin Jiangu granules, and lay the foundation for the development of new drugs.
- Conditions
- Postmenopausal Osteoporoses
- Being tested
- Xulin Jiangu granules, Calcitriol capsules
- Keywords
- Osteoporosis, kidney deficiency and blood stasis syndrome, Xuling Jiangu Granules
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xulin Jiangu granulesDrug
Xulin Jiangu granules tablets
Calcitriol capsulesDrug
Calcitriol capsules tablets
| Study group | Role | What they receive |
|---|---|---|
| Xulin Jiangu granules | Experimental | Xulin Jiangu granule 15g tablet by mouth every 6 hour for 6 months Receives: Drug: Xulin Jiangu granules; Drug: Calcitriol capsules |
| Calcitriol capsules | Active comparator | Calcitriol capsules tablets 0.25 ug by mouth every 6 hour for 6 months Receives: Drug: Xulin Jiangu granules; Drug: Calcitriol capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density（BMD）
BMD is the gold standard of oeteoporosis
Measured: Xulin Jiangu treats for up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start1 Sep 2019 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosesStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Academy of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563235
- Sponsor's protocol ID
- 2018R1035-4
- Acronym
- CSOPOPWXJG
- Status last verified
- Feb 2019
- First submitted
- 31 May 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules
- ClinicalTrials.gov ID
- NCT03563235
- Acronym / sponsor ID
- CSOPOPWXJG / 2018R1035-4
- Conditions
- Postmenopausal Osteoporoses
- Keywords
- Osteoporosis, kidney deficiency and blood stasis syndrome, Xuling Jiangu Granules
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fujian Academy of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Jun 2018 (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.
Osteoporosis is a common senile disease with a high incidence. The Chinese medicine differentiation treatment has small side effects and can be taken for a long time, which has certain advantages. This project adopts the experience of the person in charge of the project-Xulin Jiangu Granules and clinically collects patients with postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome).
Detailed description
Randomized control method was used to observe the clinical efficacy of the treatment of postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome) with jiujian jiangu granules, combined with the gene expression of bone metabolism markers BALP, PINP, TRACP and S-CTX, and RANK, RANKL and OPG Detection, compared with the control group of ossification trihydrate capsules, to explore the mechanism of the treatment of postmenopausal osteoporosis by the continued Xulin Jiangu granules, and lay the foundation for the development of new drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xulin Jiangu granules | Experimental | Drug: Xulin Jiangu granules, Drug: Calcitriol capsulesXulin Jiangu granule 15g tablet by mouth every 6 hour for 6 months |
| Calcitriol capsules | Active comparator | Drug: Xulin Jiangu granules, Drug: Calcitriol capsulesCalcitriol capsules tablets 0.25 ug by mouth every 6 hour for 6 months |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 2 years prior and met the diagnostic criteria for osteoporosis according to the "clinical practice guidelines of traditional medicine for primary osteoporosis
- met the CM diagnostic criteria according to "Syndrome Differentiation in Modern Research of Traditional Chinese Medicine
Key exclusion criteria (4 listed)
- patients who did not meet the diagnostic criteria for osteoporosis or CM standards
- patients with rheumatoid arthritis, diabetes, secondary osteoporosis due to hyperthyroidism, and severe cardiovascular or cerebrovascular diseases
- patients with abnormal liver and/or Shen function test results
- patients with osteoporosis who had received treatment with CM within the last month, hormone replacement therapy and calcitonin within the past three months, or bisphosphonates for 15 consecutive days within the past 6 months.
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 |
|---|---|---|
| Xulin Jiangu granulesXulin Jiangu granules tablets | Drug | Calcitriol capsules, Xulin Jiangu granules |
| Calcitriol capsulesCalcitriol capsules tablets | Drug | Calcitriol capsules, Xulin Jiangu granules |
Primary outcome
Bone density（BMD）
Time frame: Xulin Jiangu treats for up to six months
BMD is the gold standard of oeteoporosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Postmenopausal Osteoporoses
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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?
A Early Phase 1 study testing Xulin Jiangu granules and Calcitriol capsules in people with Postmenopausal Osteoporoses, run by Fujian Academy of Traditional Chinese Medicine 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 2 inclusion and 4 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 26 Feb 2019. 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?
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?
Bone density（BMD） (time frame: Xulin Jiangu treats for up to six 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 26 Feb 2019.