Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy

Phase 2

Withdrawn

• Conditions: Renal Insufficiency, Chronic; Renal Osteodystrophy
• Interventions: Drug: Zuogui granules placebo; Drug: Yougui granules placebo; Drug: Zuogui granules; Drug: Yougui granules

• Registration Number: NCT01665651
• Lead Sponsor: Bing Shu

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-12
• Study First Posted: 2012-08-15
• Status Verified: 2017-05
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density	3 months

Secondary Outcome Measures

Name	Time	Method
Kidney Yin and Yang evaluation	3 months	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.
Blood Urea Nitrogen	3 months	BUN will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
creatinine	3 months	Creatinine will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
bone metabolism	3 months	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).

Trial Locations

Locations (3)

Huadong hospital affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China

Longhua Hospital affiliated to Shanghai Uni of TCM; 🇨🇳 Shanghai, Shanghai, China

The first affiliated hospital of Anhui University of TCM; 🇨🇳 Hefei, Anhui, China