NCT01665651

Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bing Shu · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Insufficiency, Chronic
• Renal Osteodystrophy

Interventions

Type	Name	Description
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.
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.
DRUG	Yougui granules placebo	Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
DRUG	Zuogui granules placebo	Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.

Timeline

• Start date: 2012-08-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2012-08-15
• Last updated: 2017-05-08

Locations

3 sites across 1 country: China