Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Renal Insufficiency, Chronic; Renal Osteodystrophy
• Intervention / Treatment: Drug: Zuogui granules placebo; Drug: Yougui granules placebo; Drug: Zuogui granules; Drug: Yougui granules

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230031
      • The first affiliated hospital of Anhui University of TCM
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Huadong Hospital Affiliated to Fudan University
    • Shanghai, Shanghai, China, 200032
      • Longhua Hospital affiliated to Shanghai Uni of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Drug: Zuogui granules placebo; Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
Placebo Comparator: 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.	Drug: Yougui granules placebo; Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
Experimental: 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.	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.
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
miRNA array	3 months
bone morphogenetic protein 7	3 months

Collaborators and Investigators

• Sponsor: Bing Shu
• Collaborators: Huadong Hospital; Longhua Hospital; The First Affiliated Hospital of Anhui University of Chinese Medicine
• Investigators: Principal Investigator: Yongjun Wang, Doctor, Longhua Hospital affiliated to Shanghai Uni of TCM

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: August 8, 2012
• First Submitted That Met QC Criteria: August 12, 2012
• First Posted (Estimate): August 15, 2012

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Nutrition Disorders; Musculoskeletal Diseases; Parathyroid Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Bone Diseases; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Rickets; Vitamin D Deficiency; Hyperparathyroidism, Secondary; Hyperparathyroidism; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Kidney Disease-Mineral and Bone Disorder
• Other Study ID Numbers: Kidney Yin/Yang replenishment