A Phase 2 interventional study of Yougui granules and Zuogui granules in Renal Insufficiency, Chronic and Renal Osteodystrophy, sponsored by Bing Shu. Withdrawn at 3 sites in China. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-08.
Sponsored by Bing Shu · Phase 2, Interventional, and Prevention
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.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
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Exclusion Criteria:
chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules placebo treatment besides basic treatment.
Drug: Zuogui granules placebo
chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules placebo treatment besides basic treatment.
Drug: Yougui granules placebo
chronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules treatment besides basic treatment.
Drug: Zuogui granules
chronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules treatment besides basic treatment.
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.
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.
Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
Bone Mineral Density
Time frame: 3 months
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.
Time frame: 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).
Time frame: 3 months
Blood Urea Nitrogen
BUN will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
Time frame: 3 months
creatinine
Creatinine will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
Time frame: 3 months
miRNA array
Time frame: 3 months
bone morphogenetic protein 7
Time frame: 3 months
The record gives a start of Aug 2012, a primary completion of May 2017 and a completion of May 2017. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →