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| Name | Class |
|---|---|
| Huadong Hospital | OTHER |
| The First Affiliated Hospital of Anhui University of Chinese Medicine | OTHER |
| Longhua Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| kidney Yin deficiency with placebo | Placebo Comparator | chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules placebo treatment besides basic treatment. |
|
| kidney Yang deficiency with placebo | Placebo Comparator | chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules placebo treatment besides basic treatment. |
|
| kidney Yin deficiency with Zuogui | Experimental | chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules treatment besides basic treatment. |
|
| kidney Yang deficiency with Yougui | Experimental | chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules treatment besides basic treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yougui granules | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density | 3 months |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| miRNA array | 3 months | |
| bone morphogenetic protein 7 | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongjun Wang, Doctor | Longhua hospital affiliated to Shanghai Uni of TCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Anhui University of TCM | Hefei | Anhui | 230031 | China | ||
| Huadong hospital affiliated to Fudan University |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Zuogui granules | Drug | 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. |
|
| Yougui granules placebo | Drug | Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months. |
|
| Zuogui granules placebo | Drug | Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months. |
|
| 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 |
| Shanghai |
| Shanghai Municipality |
| 200000 |
| China |
| Longhua Hospital affiliated to Shanghai Uni of TCM | Shanghai | Shanghai Municipality | 200032 | China |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |