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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04557553
Other study ID # SUNT001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2019
Est. completion date July 13, 2022

Study information

Verified date April 2023
Source Southern California University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To study the effects of the herbal supplement Lagenbone on Bone Mineral Density


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date July 13, 2022
Est. primary completion date July 13, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Lagenbone
Traditional Chinese medicine herbal formula

Locations

Country Name City State
United States Southern California University of Health Sciences Whittier California

Sponsors (2)

Lead Sponsor Collaborator
Southern California University of Health Sciences Sun Ten Pharmaceutical Co Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dual-energy x-ray absorptiometry (DXA)DEXA Scan Dual-energy x-ray absorptiometry (DXA) or bone densitometry or Bone Density Scan 15 months
Secondary Short Osteoporosis Quality of Life Questionnaire (ECOS16) Short Osteoporosis Quality of Life Questionnaire 15 months
Secondary 36-item Short form survey (SF36) 36-item Short form survey 15 months
Secondary Osteoporotic Quality of Life Questionnaire (OQLQ10) Osteoporotic Quality of Life Questionnaire 15 months
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