Back to resultsEffects of Lagenbone on Bone Mineral Density
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lagenbone
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring chinese medicine, herbal medicine, osteoporosis, bone mineral density
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of osteoporosis
- Able to read and understand English
- Willing to receive routine DEXA scans and comply with supplement schedule
Exclusion Criteria:
- 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
Sites / Locations
- Southern California University of Health Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lagenbone
Arm Description
Lagenbone 500mg capsules, 8 capsules by mouth every day for 12 months.
Outcomes
Primary Outcome Measures
Dual-energy x-ray absorptiometry (DXA)DEXA Scan
Dual-energy x-ray absorptiometry (DXA) or bone densitometry or Bone Density Scan
Secondary Outcome Measures
Short Osteoporosis Quality of Life Questionnaire (ECOS16)
Short Osteoporosis Quality of Life Questionnaire
36-item Short form survey (SF36)
36-item Short form survey
Osteoporotic Quality of Life Questionnaire (OQLQ10)
Osteoporotic Quality of Life Questionnaire
Full Information
NCT ID
NCT04557553
First Posted
April 30, 2020
Last Updated
April 17, 2023
Sponsor
Southern California University of Health Sciences
Collaborators
Sun Ten Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04557553
Brief Title
Effects of Lagenbone on Bone Mineral Density
Official Title
Effects of Lagenbone on Improvements in Bone Mineral Density - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
July 13, 2022 (Actual)
Study Completion Date
July 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern California University of Health Sciences
Collaborators
Sun Ten Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
chinese medicine, herbal medicine, osteoporosis, bone mineral density
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lagenbone
Arm Type
Experimental
Arm Description
Lagenbone 500mg capsules, 8 capsules by mouth every day for 12 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lagenbone
Other Intervention Name(s)
Gui Lu Er Xian Jiao
Intervention Description
Traditional Chinese medicine herbal formula
Primary Outcome Measure Information:
Title
Dual-energy x-ray absorptiometry (DXA)DEXA Scan
Description
Dual-energy x-ray absorptiometry (DXA) or bone densitometry or Bone Density Scan
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Short Osteoporosis Quality of Life Questionnaire (ECOS16)
Description
Short Osteoporosis Quality of Life Questionnaire
Time Frame
15 months
Title
36-item Short form survey (SF36)
Description
36-item Short form survey
Time Frame
15 months
Title
Osteoporotic Quality of Life Questionnaire (OQLQ10)
Description
Osteoporotic Quality of Life Questionnaire
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of osteoporosis
Able to read and understand English
Willing to receive routine DEXA scans and comply with supplement schedule
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasad S Vinjamury, DACM, MPH
Organizational Affiliation
Southern California University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California University of Health Sciences
City
Whittier
State/Province
California
ZIP/Postal Code
90604
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Lagenbone on Bone Mineral Density
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