Clinical Trial: Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Bing Shu

Current Primary Outcome: Bone Mineral Density [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Kidney Yin and Yang evaluation [ Time Frame: 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.

  • bone metabolism [ Time Frame: 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).
  • Blood Urea Nitrogen [ Time Frame: 3 months ]
    BUN will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
  • creatinine [ Time Frame: 3 months ]
    Creatinine will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)


Original Secondary Outcome: Same as current

Information By: Shanghai University of Traditional Chinese Medicine

Dates:
Date Received: August 8, 2012
Date Started: August 2012
Date Completion:
Last Updated: May 4, 2017
Last Verified: May 2017