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Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy

Primary Purpose

Renal Insufficiency, Chronic, Renal Osteodystrophy

Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Yougui granules
Zuogui granules
Yougui granules placebo
Zuogui granules placebo
Sponsored by
Bing Shu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Insufficiency, Chronic

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • chronic renal insufficiency
  • bone loss or osteoporosis
  • 30-50 years old
  • kidney Yin or Yang deficiency evaluated with traditional Chinese medicine
  • be willing to and be able to join in the study and signed Informed consent
  • have not accepted systematical treatment on bone loss or osteoporosis

Exclusion Criteria:

  • allergies
  • secondary osteoporosis caused by other diseases.
  • postmenopausal women
  • mental illness or psychosis
  • patients with bone fracture and need surgery treatment
  • taking any medicine that will affect bone metabolism for a long time and can not stop
  • women during pregnant stage and breast-feed stage

Sites / Locations

  • The first affiliated hospital of Anhui University of TCM
  • Huadong hospital affiliated to Fudan University
  • Longhua Hospital affiliated to Shanghai Uni of TCM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Arm Label

kidney Yin deficiency with placebo

kidney Yang deficiency with placebo

kidney Yin deficiency with Zuogui

kidney Yang deficiency with Yougui

Arm Description

chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules placebo treatment besides basic treatment.

chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules placebo treatment besides basic treatment.

chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules treatment besides basic treatment.

chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules treatment besides basic treatment.

Outcomes

Primary Outcome Measures

Bone Mineral Density

Secondary Outcome Measures

Kidney Yin and Yang evaluation
Function of Kidney Yin and Yang will be evaluated with Traditional Chinese Medicine methods before and after treatment(Kidney Yin/Yang replenishment) to check whether function of Kidney Yin and Yang are improved. In Traditional Chinese Medicine, function of Kidney Yin and Yang are evaluated according to some specific symptoms and the severity including soreness of the waist and knee, exhausted, tinnitus, hard of hearing, hair loss, white hair, dizziness, dry mouth, red flush in face, night sweating, hot flashes, insomnia, dreaminess, the status of tongue body and coating and so on.
bone metabolism
bone alkaline phosphatase, fibroblast growth factor 23, Osteocalcin, Parathyroid hormone , 1,25(OH)2D3, serum and urinal Ca, P will be detected to check whether bone metabolism is improved after treatment(Kidney Yin/Yang replenishment).
Blood Urea Nitrogen
BUN will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
creatinine
Creatinine will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)

Full Information

First Posted
August 8, 2012
Last Updated
May 4, 2017
Sponsor
Bing Shu
Collaborators
Huadong Hospital, The First Affiliated Hospital of Anhui University of Chinese Medicine, Longhua Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01665651
Brief Title
Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy
Official Title
Effect of Kidney Yin/Yang Replenishment on Bone Metabolism in Patients With Renal Osteodystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Hard to enroll participants
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bing Shu
Collaborators
Huadong Hospital, The First Affiliated Hospital of Anhui University of Chinese Medicine, Longhua Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with serious chronic renal insufficiency usually develop secondary osteoporosis or bone loss, especially those with chronic dialysis, and the degree of bone loss is corrected with decrease of renal function. In traditional Chinese medicine, kidney function is considered to dominate bone development and metabolism. Kidney Yin and Yang replenishment will help improve bone development and metabolism.
Detailed Description
In this study patients with chronic renal insufficiency and secondary osteoporosis or bone loss will be evaluated with traditional Chinese medicine standard and allocated into kidney Yin deficiency and kidney Yang deficiency groups. In Yin deficiency group, patients will be divided into Zuogui granules treatment group and placebo group. In Yang deficiency group, patients will be divided into Yuogui granules treatment group and placebo group. All the patients will also accept basic treatment. After 3-month-treatment, we will detect blood urea nitrogen, creatinine, bone mineral density, bone metabolism markers including FGF23, 1,25(OH)2D3, Osteocalcin, PTH, BALP, serum and urinal Ca, P. We will also perform miRNA array. The data before treatment and after treatment will be compared. The data of treatment groups and placebo groups will also be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic, Renal Osteodystrophy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
kidney Yin deficiency with placebo
Arm Type
Placebo Comparator
Arm Description
chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules placebo treatment besides basic treatment.
Arm Title
kidney Yang deficiency with placebo
Arm Type
Placebo Comparator
Arm Description
chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules placebo treatment besides basic treatment.
Arm Title
kidney Yin deficiency with Zuogui
Arm Type
Experimental
Arm Description
chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules treatment besides basic treatment.
Arm Title
kidney Yang deficiency with Yougui
Arm Type
Experimental
Arm Description
chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules treatment besides basic treatment.
Intervention Type
Drug
Intervention Name(s)
Yougui granules
Intervention Description
Yougui granules is traditional Chinese patent medicine used to treatment patients with kidney Yang deficiency. Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
Intervention Type
Drug
Intervention Name(s)
Zuogui granules
Intervention Description
Zuogui granules is traditional Chinese patent medicine used to treatment patients with kidney Yin deficiency. Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
Intervention Type
Drug
Intervention Name(s)
Yougui granules placebo
Intervention Description
Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
Intervention Type
Drug
Intervention Name(s)
Zuogui granules placebo
Intervention Description
Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
Primary Outcome Measure Information:
Title
Bone Mineral Density
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Kidney Yin and Yang evaluation
Description
Function of Kidney Yin and Yang will be evaluated with Traditional Chinese Medicine methods before and after treatment(Kidney Yin/Yang replenishment) to check whether function of Kidney Yin and Yang are improved. In Traditional Chinese Medicine, function of Kidney Yin and Yang are evaluated according to some specific symptoms and the severity including soreness of the waist and knee, exhausted, tinnitus, hard of hearing, hair loss, white hair, dizziness, dry mouth, red flush in face, night sweating, hot flashes, insomnia, dreaminess, the status of tongue body and coating and so on.
Time Frame
3 months
Title
bone metabolism
Description
bone alkaline phosphatase, fibroblast growth factor 23, Osteocalcin, Parathyroid hormone , 1,25(OH)2D3, serum and urinal Ca, P will be detected to check whether bone metabolism is improved after treatment(Kidney Yin/Yang replenishment).
Time Frame
3 months
Title
Blood Urea Nitrogen
Description
BUN will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
Time Frame
3 months
Title
creatinine
Description
Creatinine will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
miRNA array
Time Frame
3 months
Title
bone morphogenetic protein 7
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: chronic renal insufficiency bone loss or osteoporosis 30-50 years old kidney Yin or Yang deficiency evaluated with traditional Chinese medicine be willing to and be able to join in the study and signed Informed consent have not accepted systematical treatment on bone loss or osteoporosis Exclusion Criteria: allergies secondary osteoporosis caused by other diseases. postmenopausal women mental illness or psychosis patients with bone fracture and need surgery treatment taking any medicine that will affect bone metabolism for a long time and can not stop women during pregnant stage and breast-feed stage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang, Doctor
Organizational Affiliation
Longhua hospital affiliated to Shanghai Uni of TCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of Anhui University of TCM
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Facility Name
Huadong hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Longhua Hospital affiliated to Shanghai Uni of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy

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