Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Shanghai University of Traditional Chinese Medicine
Sponsor:
Collaborators:
Jiangsu province hospital of TCM
China-Japan Friendship Hospital
First Affiliated Hospital of Zhejiang University
Information provided by (Responsible Party):
Bing Shu, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01665651
First received: August 8, 2012
Last updated: August 12, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665651

Contacts
Contact: Bing Shu, Doctor 01186-21-64385700 ext 2520 shubing523@hotmail.com

Locations
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         
Sponsors and Collaborators
Bing Shu
Jiangsu province hospital of TCM
China-Japan Friendship Hospital
First Affiliated Hospital of Zhejiang University
Investigators
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 August 26, 2014