OsteoporosisNCT04557553
Effects of Lagenbone on Bone Mineral Density
A study testing Lagenbone in people with Osteoporosis, run by Southern California University of Health Sciences at 1 site in United States.
Trial summary
To study the effects of the herbal supplement Lagenbone on Bone Mineral Density Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Lagenbone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 13 Jul 2022
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of osteoporosis
- Able to read and understand English
- Willing to receive routine DEXA scans and comply with supplement schedule
Who cannot join
- Pregnant, lactating, or having gestational diabetes
- Diagnosed with comorbid conditions that they are taking medication for e.g. Acid reflux, Hashimoto's/Grave's Disease, Endometriosis, prostate, breast, uterine cancer, kidney disease, fibroids, psychological disorders
- Use of any medication known to interfere with bone mineral density
- Are taking any new medications/supplements/treatments/therapeutic exercise within the last two months for osteoporosis or bone density
- Involved in health-related litigation, claims
- Missing baseline visits
- Vegan or vegetarian
- Diagnosed with Alzheimer's or demonstrating onset of dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California University of Health Sciences
Whittier, California, 90604
About this study
Official title: Effects of Lagenbone on Improvements in Bone Mineral Density - A Pilot Study
To study the effects of the herbal supplement Lagenbone on Bone Mineral Density
Read the detailed description
To study the effects of the herbal supplement Lagenbone on Bone Mineral Density. Lagenbone is a supplement based on the Chinese Herbal formula Gui Lu Er Xian Jiao.
- Conditions
- Osteoporosis
- Being tested
- Lagenbone
- Keywords
- chinese medicine, herbal medicine, osteoporosis, bone mineral density
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LagenboneDietary supplement
Also called Gui Lu Er Xian Jiao
Traditional Chinese medicine herbal formula
| Study group | Role | What they receive |
|---|---|---|
| Lagenbone | Experimental | Lagenbone 500mg capsules, 8 capsules by mouth every day for 12 months. Receives: Dietary Supplement: Lagenbone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-energy x-ray absorptiometry (DXA)DEXA Scan
Dual-energy x-ray absorptiometry (DXA) or bone densitometry or Bone Density Scan
Measured: 15 months
Secondary outcomes (3)
Short Osteoporosis Quality of Life Questionnaire (ECOS16)
Short Osteoporosis Quality of Life Questionnaire
Measured: 15 months
36-item Short form survey (SF36)
36-item Short form survey
Measured: 15 months
Osteoporotic Quality of Life Questionnaire (OQLQ10)
Osteoporotic Quality of Life Questionnaire
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start15 Jul 2019
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Ten Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Sivarama Vinjamury, Southern California University of Health Sciences
- Investigators
- Prasad S Vinjamury, DACM, MPH, Principal investigator, Southern California University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557553
- Sponsor's protocol ID
- SUNT001
- Status last verified
- Apr 2023
- First submitted
- 30 Apr 2020
- Last updated
- 19 Apr 2023
- 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 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lagenbone on Improvements in Bone Mineral Density - A Pilot Study
- ClinicalTrials.gov ID
- NCT04557553
- Acronym / sponsor ID
- SUNT001
- Conditions
- Osteoporosis
- Keywords
- chinese medicine, herbal medicine, osteoporosis, bone mineral density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Southern California University of Health SciencesUniversity, hospital or other
- Collaborators
- Sun Ten Pharmaceutical Co., Ltd.
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 21 Sep 2020 (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 study the effects of the herbal supplement Lagenbone on Bone Mineral Density
Detailed description
To study the effects of the herbal supplement Lagenbone on Bone Mineral Density. Lagenbone is a supplement based on the Chinese Herbal formula Gui Lu Er Xian Jiao.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lagenbone | Experimental | Dietary Supplement: LagenboneLagenbone 500mg capsules, 8 capsules by mouth every day for 12 months. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of osteoporosis
- Able to read and understand English
- Willing to receive routine DEXA scans and comply with supplement schedule
Key exclusion criteria (8 listed)
- Pregnant, lactating, or having gestational diabetes
- Diagnosed with comorbid conditions that they are taking medication for e.g. Acid reflux, Hashimoto's/Grave's Disease, Endometriosis, prostate, breast, uterine cancer, kidney disease, fibroids, psychological disorders
- Use of any medication known to interfere with bone mineral density
- Are taking any new medications/supplements/treatments/therapeutic exercise within the last two months for osteoporosis or bone density
- Involved in health-related litigation, claims
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 |
|---|---|---|
| LagenboneAlso: Gui Lu Er Xian JiaoTraditional Chinese medicine herbal formula | Dietary supplement | Lagenbone |
Primary outcome
Dual-energy x-ray absorptiometry (DXA)DEXA Scan
Time frame: 15 months
Dual-energy x-ray absorptiometry (DXA) or bone densitometry or Bone Density Scan
3 secondary outcomes
Short Osteoporosis Quality of Life Questionnaire (ECOS16)
Time frame: 15 months
36-item Short form survey (SF36)
Time frame: 15 months
Osteoporotic Quality of Life Questionnaire (OQLQ10)
Time frame: 15 months
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 19 Apr 2023.
- 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.
Prasad S Vinjamury, DACM, MPH principal investigator
Southern California University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lagenbone in people with Osteoporosis, run by Southern California University of Health Sciences at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 19 Apr 2023. 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 United States. 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?
Dual-energy x-ray absorptiometry (DXA)DEXA Scan (time frame: 15 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 19 Apr 2023.