Effects of Lagenbone on Bone Mineral Density

April 17, 2023 updated by: Sivarama Vinjamury, Southern California University of Health Sciences

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Whittier, California, United States, 90604
        • Southern California University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lagenbone
Lagenbone 500mg capsules, 8 capsules by mouth every day for 12 months.
Dietary supplement: Lagenbone
Traditional Chinese medicine herbal formula
Other Names:
  • Gui Lu Er Xian Jiao

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Osteoporosis Quality of Life Questionnaire (ECOS16)
Time Frame: 15 months
Short Osteoporosis Quality of Life Questionnaire
15 months
36-item Short form survey (SF36)
Time Frame: 15 months
36-item Short form survey
15 months
Osteoporotic Quality of Life Questionnaire (OQLQ10)
Time Frame: 15 months
Osteoporotic Quality of Life Questionnaire
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California University of Health Sciences

Collaborators

Sun Ten Pharmaceutical Co Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2019

Primary Completion (Actual)

July 13, 2022

Study Completion (Actual)

July 13, 2022

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUNT001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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