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Effects of Lagenbone on Bone Mineral Density

Sponsor
Southern California University of Health Sciences (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04557553
Collaborator
Sun Ten Pharmaceutical Co Ltd. (Other)
10
Enrollment
1
Location
1
Arm
33.5
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Lagenbone
 N/A

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

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Lagenbone on Improvements in Bone Mineral Density - A Pilot Study
Actual Study Start Date :
Jul 15, 2019
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dual-energy x-ray absorptiometry (DXA)DEXA Scan [15 months]

      Dual-energy x-ray absorptiometry (DXA) or bone densitometry or Bone Density Scan

    Secondary Outcome Measures

    1. Short Osteoporosis Quality of Life Questionnaire (ECOS16) [15 months]

      Short Osteoporosis Quality of Life Questionnaire

    2. 36-item Short form survey (SF36) [15 months]

      36-item Short form survey

    3. Osteoporotic Quality of Life Questionnaire (OQLQ10) [15 months]

      Osteoporotic Quality of Life Questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southern California University of Health Sciences Whittier California United States 90604

    Sponsors and Collaborators

    • Southern California University of Health Sciences
    • Sun Ten Pharmaceutical Co Ltd.

    Investigators

    • Principal Investigator: Prasad S Vinjamury, DACM, MPH, Southern California University of Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sivarama Vinjamury, Professor, Research Director, Southern California University of Health Sciences
    ClinicalTrials.gov Identifier:
    NCT04557553
    Other Study ID Numbers:
    • SUNT001
    First Posted:
    Sep 21, 2020
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sivarama Vinjamury, Professor, Research Director, Southern California University of Health Sciences
    chinese medicine
    herbal medicine
    osteoporosis
    bone mineral density
    Additional relevant MeSH terms:
    Osteoporosis

    Study Results

    No Results Posted as of Sep 5, 2021