Effects of Lagenbone on Bone Mineral Density

NCT ID: NCT04557553

Last Updated: 2023-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2022-07-13

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lagenbone

Lagenbone 500mg capsules, 8 capsules by mouth every day for 12 months.

Group Type EXPERIMENTAL

Lagenbone

Intervention Type DIETARY_SUPPLEMENT

Traditional Chinese medicine herbal formula

Interventions

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Lagenbone

Traditional Chinese medicine herbal formula

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Gui Lu Er Xian Jiao

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Ten Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Southern California University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sivarama Vinjamury

Professor, Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prasad S Vinjamury, DACM, MPH

Role: PRINCIPAL_INVESTIGATOR

Southern California University of Health Sciences

Locations

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Southern California University of Health Sciences

Whittier, California, United States

Site Status

Countries

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United States

Other Identifiers

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SUNT001

Identifier Type: -

Identifier Source: org_study_id

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