Renal Insufficiency, Chronic, Renal Osteodystrophy
Conditions
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.
Interventions
DRUGYougui 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.
DRUGZuogui 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.
DRUGYougui granules placebo
Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
DRUGZuogui granules placebo
Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
Sponsors
Huadong Hospital
The First Affiliated Hospital of Anhui University of Chinese Medicine
Longhua Hospital
Bing Shu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone Mineral Density | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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) |
Other
| Measure | Time frame |
|---|---|
| miRNA array | 3 months |
| bone morphogenetic protein 7 | 3 months |
Countries
China
Outcome results
None listed