Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Insufficiency, Chronic Renal Osteodystrophy |
Drug: Yougui granules Drug: Zuogui granules Drug: Yougui granules placebo Drug: Zuogui granules placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Effect of Kidney Yin/Yang Replenishment on Bone Metabolism in Patients With Renal Osteodystrophy |
- Bone Mineral Density [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Kidney Yin and Yang evaluation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]BUN will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
- creatinine [ Time Frame: 3 months ] [ Designated as safety issue: No ]Creatinine will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
- miRNA array [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- bone morphogenetic protein 7 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: kidney Yin deficiency with placebo
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
Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
|
|
Placebo Comparator: kidney Yang deficiency with 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
Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
|
|
Experimental: kidney Yin deficiency with Zuogui
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
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.
|
|
Experimental: kidney Yang deficiency with Yougui
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.
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Bing Shu, Doctor | 01186-21-64385700 ext 2520 | shubing523@hotmail.com |
| China, Beijing | |
| China-Japan friendship hospital | Not yet recruiting |
| Beijing, Beijing, China, 100000 | |
| Contact: Ping Li, Doctor 01186-10-84205566 | |
| Principal Investigator: Ping Li, Doctor | |
| China, Jiansu | |
| Jiangsu province hospital of TCM | Not yet recruiting |
| Nanjing, Jiansu, China, 210000 | |
| Contact: Wei Sun, Doctor 01186-25-86617141 | |
| Principal Investigator: Wei Sun, Doctor | |
| China, Shanghai | |
| Longhua Hospital affiliated to Shanghai Uni of TCM | Not yet recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Yiping Chen, Doctor 01186-21-64385700 | |
| Sub-Investigator: Yifei Zhong, Doctor | |
| Sub-Investigator: Xiaofeng Li, postgraduate | |
| Principal Investigator: Yueyi Deng, Doctor | |
| China, Zhejiang | |
| The first affiliated hospital of college of medicine,Zhejiang University | Not yet recruiting |
| Hangzhou, Zhejiang, China, 310000 | |
| Contact: Xuelin He, Doctor 01186-571-87236114 | |
| Principal Investigator: Xuelin He, Doctor | |
| Principal Investigator: | Yongjun Wang, Doctor | Longhua hospital affiliated to Shanghai Uni of TCM |
More Information
No publications provided
| Responsible Party: | Bing Shu, assistant research fellow, Shanghai University of Traditional Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT01665651 History of Changes |
| Other Study ID Numbers: | Kidney Yin/Yang replenishment |
| Study First Received: | August 8, 2012 |
| Last Updated: | August 12, 2012 |
| Health Authority: | China: Ministry of Science and Technology |
Additional relevant MeSH terms:
|
Renal Insufficiency Renal Osteodystrophy Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Rickets Calcium Metabolism Disorders |
Metabolic Diseases Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Hyperparathyroidism, Secondary Hyperparathyroidism Parathyroid Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013