Renal Insufficiency, ChronicPhase 2NCT01665651
Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy
A Phase 2 study testing Yougui granules and Zuogui granules in people with Renal Insufficiency, Chronic and Renal Osteodystrophy, run by Bing Shu at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Chronic, Renal Osteodystrophy
- What is being tested?
- Yougui granules and Zuogui granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesChina
- Study dates
- Aug 2012to May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
The first affiliated hospital of Anhui University of TCM
Hefei, Anhui, 230031
Huadong hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200000
Longhua Hospital affiliated to Shanghai Uni of TCM
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Effect of Kidney Yin/Yang Replenishment on Bone Metabolism in Patients With Renal Osteodystrophy
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.
Read the 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.
- Conditions
- Renal Insufficiency, Chronic, Renal Osteodystrophy
- Being tested
- Yougui granules, Zuogui granules, Yougui granules placebo, Zuogui granules placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yougui granulesDrug
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 granulesDrug
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 placeboDrug
Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
Zuogui granules placeboDrug
Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Yougui granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 3 months
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).
Measured: 3 months
Blood Urea Nitrogen
BUN will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
Measured: 3 months
creatinine
Creatinine will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: Hard to enroll participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bing Shu
- Sponsor type
- University, hospital or other
- Collaborators
- Huadong Hospital, The First Affiliated Hospital of Anhui University of Chinese Medicine, Longhua Hospital
- Responsible party
- Sponsor-investigator, Bing Shu, Shanghai University of Traditional Chinese Medicine
- Investigators
- Yongjun Wang, Doctor, Principal investigator, Longhua hospital affiliated to Shanghai Uni of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665651
- Sponsor's protocol ID
- Kidney Yin/Yang replenishment
- Status last verified
- May 2017
- First submitted
- 8 Aug 2012
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kidney Yin/Yang Replenishment on Bone Metabolism in Patients With Renal Osteodystrophy
- ClinicalTrials.gov ID
- NCT01665651
- Acronym / sponsor ID
- Kidney Yin/Yang replenishment
- Conditions
- Renal Insufficiency, Chronic, Renal Osteodystrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Hard to enroll participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bing ShuUniversity, hospital or other
- Collaborators
- Huadong Hospital, The First Affiliated Hospital of Anhui University of Chinese Medicine, Longhua Hospital
- Study start
- Aug 2012
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| kidney Yin deficiency with placebo | Placebo comparator | Drug: Zuogui granules placebochronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules placebo treatment besides basic treatment. |
| kidney Yang deficiency with placebo | Placebo comparator | Drug: Yougui granules placebochronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules placebo treatment besides basic treatment. |
| kidney Yin deficiency with Zuogui | Experimental | Drug: Zuogui granuleschronic renal insufficiency patients with kidney Yin deficiency evaluated with traditional Chinese medicine will be given Zuogui granules treatment besides basic treatment. |
| kidney Yang deficiency with Yougui | Experimental | Drug: Yougui granuleschronic renal insufficiency patients with kidney Yang deficiency evaluated with traditional Chinese medicine will be given Yougui granules treatment besides basic treatment. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- allergies
- secondary osteoporosis caused by other diseases.
- postmenopausal women
- mental illness or psychosis
- patients with bone fracture and need surgery treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yougui granulesYougui 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. | Drug | kidney Yang deficiency with Yougui |
| Zuogui granulesZuogui 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. | Drug | kidney Yin deficiency with Zuogui |
| Yougui granules placeboGranules, 11g/pouch, taking with water, 2 pouches, twice a day, three months. | Drug | kidney Yang deficiency with placebo |
| Zuogui granules placeboGranules, 11g/pouch, taking with water, 2 pouches, twice a day, three months. | Drug | kidney Yin deficiency with placebo |
Primary outcome
Bone Mineral Density
Time frame: 3 months
4 secondary outcomes
Kidney Yin and Yang evaluation
Time frame: 3 months
bone metabolism
Time frame: 3 months
Blood Urea Nitrogen
Time frame: 3 months
creatinine
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongjun Wang, Doctor principal investigator
Longhua hospital affiliated to Shanghai Uni of TCM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yougui granules and Zuogui granules in people with Renal Insufficiency, Chronic and Renal Osteodystrophy, run by Bing Shu at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.