Renal Insufficiency, Chronic Clinical Trial
Official title:
Effect of Kidney Yin/Yang Replenishment on Bone Metabolism in Patients With Renal Osteodystrophy
Verified date | May 2017 |
Source | Shanghai University of Traditional Chinese Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | The first affiliated hospital of Anhui University of TCM | Hefei | Anhui |
China | Huadong hospital affiliated to Fudan University | Shanghai | Shanghai |
China | Longhua Hospital affiliated to Shanghai Uni of TCM | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Bing Shu | Huadong Hospital, Longhua Hospital, The First Affiliated Hospital of Anhui University of Chinese Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | miRNA array | 3 months | ||
Other | bone morphogenetic protein 7 | 3 months | ||
Primary | Bone Mineral Density | 3 months | ||
Secondary | 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. |
3 months | |
Secondary | 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 | |
Secondary | Blood Urea Nitrogen | BUN will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment) | 3 months | |
Secondary | creatinine | Creatinine will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment) | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT05056727 -
A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
|
Phase 3 | |
Withdrawn |
NCT01655186 -
A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Effects of Bardoxolone Methyl on Body Composition in Patients With Stage 4 Chronic Kidney Disease and Type 2 Diabetes Mellitus
|
Phase 2 | |
Completed |
NCT03481686 -
Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections
|
N/A | |
Active, not recruiting |
NCT03672110 -
Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen
|
Phase 3 | |
Enrolling by invitation |
NCT02237534 -
Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia
|
Phase 4 | |
Completed |
NCT02126293 -
Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant
|
Phase 3 | |
Terminated |
NCT01533545 -
Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients
|
N/A | |
Completed |
NCT03280615 -
Omega 3 Fatty Acids in Patients With Chronic Renal Disease
|
Phase 3 | |
Completed |
NCT04498156 -
Survey of Patient and Physician Awareness and Values to the Diagnosis and Treatment of Reduced Kidney Function (Chronic Kidney Disease) in Patients With High Blood Sugar Level (Type 2 Diabetes) (AWARE-CKD in T2D)
|
||
Recruiting |
NCT04020328 -
Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal Insufficiency
|
Phase 4 | |
Recruiting |
NCT06366529 -
Explore New Magnetic Resonance Technology in Assessment of Renal Dysfunction
|
||
Active, not recruiting |
NCT04876963 -
HOLT-ED: Holter-monitoring in End-stage Renal Disease
|
||
Completed |
NCT03836508 -
Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis
|
N/A | |
Completed |
NCT03250715 -
Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure
|
N/A | |
Completed |
NCT03577249 -
Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation
|
Phase 2/Phase 3 | |
Completed |
NCT01975818 -
Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934
|
Phase 2 | |
Active, not recruiting |
NCT05766644 -
App-based Education Program for CKD
|
N/A | |
Active, not recruiting |
NCT02791880 -
Acute Kidney Injury Genomics and Biomarkers in TAVR Study
|
||
Recruiting |
NCT02947750 -
Neurovascular Transduction During Exercise in Chronic Kidney Disease
|
Phase 2 | |
Terminated |
NCT02286258 -
Validation of New Markers of Glomerular Filtration Rate: Dota Gadolinium and Calcium EDTA (MultiGFR)
|
Phase 1/Phase 2 |