Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy

NCT01665651 | Withdrawn Phase 2 DMC

• 1 other identifier: Kidney Yin/Yang replenishment
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Renal Insufficiency, Chronic; Renal Osteodystrophy

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density

  3 months

Secondary Outcomes (4)

• Kidney Yin and Yang evaluation

  3 months

• bone metabolism

  3 months

• Blood Urea Nitrogen

  3 months

• creatinine

  3 months

Other Outcomes (2)

• miRNA array

  3 months

• bone morphogenetic protein 7

  3 months

Study Arms (4)

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.

Drug: Zuogui granules placebo

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.

Drug: Yougui granules placebo

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.

Drug: Zuogui granules

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.

Drug: Yougui granules

Interventions

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.

kidney Yang deficiency with Yougui

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.

kidney Yin deficiency with Zuogui

Yougui granules placebo DRUG

Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.

kidney Yang deficiency with placebo

Zuogui granules placebo DRUG

Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.

kidney Yin deficiency with placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• chronic renal insufficiency
• bone loss or osteoporosis
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bing Shu: lead
• Huadong Hospital: collaborator
• The First Affiliated Hospital of Anhui University of Chinese Medicine: collaborator
• Longhua Hospital: collaborator

Study Sites (3)

The first affiliated hospital of Anhui University of TCM

Hefei, Anhui, 230031, China

Location

Huadong hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Longhua Hospital affiliated to Shanghai Uni of TCM

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Yongjun Wang, Doctor

  Longhua hospital affiliated to Shanghai Uni of TCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant research fellow

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 15, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

CN (3)