Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy

Bing Shu

Status and phase: Withdrawn; Phase 2

Conditions: Renal Osteodystrophy; Renal Insufficiency, Chronic

Treatments: Drug: Zuogui granules placebo; Drug: Yougui granules; Drug: Yougui granules placebo; Drug: Zuogui granules

Study type: Interventional

Funder types: Other

Identifiers

NCT01665651

Kidney Yin/Yang replenishment

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups, including a placebo group

kidney Yin deficiency with placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Zuogui granules placebo

kidney Yang deficiency with placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Yougui granules placebo

kidney Yin deficiency with Zuogui

Experimental group

Description:

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

Treatment:

Drug: Zuogui granules

kidney Yang deficiency with Yougui

Experimental group

Description:

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

Treatment:

Drug: Yougui granules