Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy

Renal Insufficiency, Chronic Clinical Trial

Official title:

Effect of Kidney Yin/Yang Replenishment on Bone Metabolism in Patients With Renal Osteodystrophy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01665651
• Other study ID #: Kidney Yin/Yang replenishment
• Status: Withdrawn
• Phase: Phase 2
• First received: August 8, 2012
• Last updated: May 4, 2017
• Start date: August 2012
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic
• Renal Osteodystrophy

Intervention

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
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.
• Yougui granules placebo
Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
• Zuogui granules placebo
Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Bing Shu	Huadong Hospital, Longhua Hospital, The First Affiliated Hospital of Anhui University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

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