Effects of Lagenbone on Bone Mineral Density

Osteoporosis Clinical Trial

Official title:

Effects of Lagenbone on Improvements in Bone Mineral Density - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557553
• Other study ID #: SUNT001
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Osteoporosis

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