Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy

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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-05-31

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.

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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.

Conditions

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Renal Insufficiency, Chronic Renal Osteodystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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kidney Yin deficiency with placebo

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

Group Type PLACEBO_COMPARATOR

Zuogui granules placebo

Intervention Type DRUG

Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.

kidney Yang deficiency with placebo

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

Group Type PLACEBO_COMPARATOR

Yougui granules placebo

Intervention Type DRUG

Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.

kidney Yin deficiency with Zuogui

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

Group Type EXPERIMENTAL

Zuogui granules

Intervention Type DRUG

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.

kidney Yang deficiency with Yougui

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

Group Type EXPERIMENTAL

Yougui granules

Intervention Type DRUG

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.

Interventions

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Yougui granules

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

Zuogui granules

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

Yougui granules placebo

Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.

Intervention Type DRUG

Zuogui granules placebo

Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes