Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Kidney Yin/Yang Replenishment on Bone Metabolism in Patients With Renal Osteodystrophy

Conditions
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Renal Insufficiency, Chronic, Renal Osteodystrophy

Intervention / Treatment
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* Drug: Yougui granules
* Drug: Zuogui granules
* Drug: Yougui granules placebo
* Drug: Zuogui granules placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: kidney Yin deficiency with placebo<br>chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules placebo treatment besides basic treatment. | Drug: Zuogui granules placebo<br>* Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.<br>|
| Placebo Comparator: kidney Yang deficiency with placebo<br>chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules placebo treatment besides basic treatment. | Drug: Yougui granules placebo<br>* Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.<br>|
| Experimental: kidney Yin deficiency with Zuogui<br>chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules treatment besides basic treatment. | Drug: Zuogui granules<br>* 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.<br>|
| Experimental: kidney Yang deficiency with Yougui<br>chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules treatment besides basic treatment. | Drug: Yougui granules<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 
| 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). | 3 months | 
| Blood Urea Nitrogen | BUN will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment) | 3 months | 
| creatinine | Creatinine will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment) | 3 months |