Diabetic Peripheral NeuropathyXBNCT02039544
A Study of Xuebi Formula for Diabetic Peripheral Neuropathy(Qi-deficiency and Blood-stasis)
A study testing Xuebi formula in people with Diabetic Peripheral Neuropathy and Diabetes, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi Deficiency and Blood Stasis) Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Diabetes, Chinese Herbs
- What is being tested?
- Xuebi formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to May 2015
- Phase
- Interventional
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- did not meet the inclusion criteria, or incomplete information affect the clinical syndrome differentiation type;
- repeated hypoglycemia reaction, nearly a month diabetic ketoacidosis, DKAand severe infections;
- blood pressure without control or after control, SBP ≥ 160mmHg or (and)DBP ≥ 100mmHg;
- TG≥ 5.6mmol / L;
- diabetic lower extremity vascular disease (resting ankle brachial index in patients with ABI ≤ 0.90 or lower extremity ultrasound vascular stenosis > 50%).
- pregnancy, to pregnant or lactating women;
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- the ingredients allergy of Chinese herbal medicine and allergic constitution person;
- psychiatric patients;
- have serious heart, lung, liver, kidney, brain and other complications overassociated with other severe primary diseases;
- other patients had participated in clinical trials or are in other clinical trials before the test in January;
- in the past 5 years with alcohol and / or psychoactive substances, drug abuse and dependence;
- according to the researcher's judgment, can reduce the possibility of the group or other diseases or conditions were complicated, such as work environment change frequently, the living environment is not stable, easy to cause lost
- hepatic, renal impairment (ALT, AST is greater than 2.5 times the upper limit of normal value; serum creatinine greater than 1.5 times the upper limit of normal value);
- demyelinating lesions or from other causes of polyneuropathy patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi Deficiency and Blood Stasis)
A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi Deficiency and Blood Stasis)
Read the detailed description
Charged by the sponsor in line with traditional Chinese medicine Qi deficiency and blood stasis syndrome 60 cases have DPN，they were randomly divided into Chinese herbal compound Xuebi prescription group and placebo group. The treatment groups were compared 24-week composite score.
- Conditions
- Diabetic Peripheral Neuropathy, Diabetes, Chinese Herbs
- Being tested
- Xuebi formula, placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xuebi formulaDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Xuebi formula | Experimental | Xuebi formula , one dosage ,every day, treat 6 months. Receives: Drug: Xuebi formula |
| Placebo | Placebo comparator | placebo,has the same taste and color as Xuebi formula one dosage ,every day, treat 6 months. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Scores of TCM clinical symptom and the clinical scoring system of Toronto (TCSS)
- Scores of TCM clinical symptom. Using statistical table score, main symptoms and secondary symptoms according to the degree is divided into light, medium, heavy, the main symptoms were recorded 2, 4, 6 points, the secondary symptoms were recorded 1, 2, 3 points. No symptomatic record 0 points. Before the study, of 4, 8, 12, 16, 20, 24 week each recorded 1 times. Description of tongue and pulse only, not scoring.
- the clinical scoring system of Toronto (TCSS). TCSS includes a score of neural symptoms, nerve reflex scores and sensory examination , a total of 19 points.Before the study, of 4, 8, 12, 16, 20, 24 week each scoring 1 times.According to the classification standard, 0-5 points does not have DPN, 6-8 points for mild DPN, 9-11 points for moderate DPN, 12-19 points for severe DPN.
Measured: 24weeks
Secondary outcomes (1)
Change in Nerve conduction velocity
Nerve conduction velocity are recorded at 0,12th,24th weeks.
Measured: 24Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengmei Lian, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Xiaolin Tong, PHD, Study chair, Guang'anmen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039544
- Sponsor's protocol ID
- 20131205
- Acronym
- XB
- Status last verified
- Jan 2014
- First submitted
- 8 Dec 2013
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi Deficiency and Blood Stasis)
- ClinicalTrials.gov ID
- NCT02039544
- Acronym / sponsor ID
- XB / 20131205
- Conditions
- Diabetic Peripheral Neuropathy, Diabetes, Chinese Herbs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 17 Jan 2014 (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.
A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi Deficiency and Blood Stasis)
Detailed description
Charged by the sponsor in line with traditional Chinese medicine Qi deficiency and blood stasis syndrome 60 cases have DPN，they were randomly divided into Chinese herbal compound Xuebi prescription group and placebo group. The treatment groups were compared 24-week composite score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xuebi formula | Experimental | Drug: Xuebi formulaXuebi formula , one dosage ,every day, treat 6 months. |
| Placebo | Placebo comparator | Drug: placeboplacebo,has the same taste and color as Xuebi formula one dosage ,every day, treat 6 months. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- did not meet the inclusion criteria, or incomplete information affect the clinical syndrome differentiation type;
- repeated hypoglycemia reaction, nearly a month diabetic ketoacidosis, DKAand severe infections;
- blood pressure without control or after control, SBP ≥ 160mmHg or (and)DBP ≥ 100mmHg;
- TG≥ 5.6mmol / L;
- diabetic lower extremity vascular disease (resting ankle brachial index in patients with ABI ≤ 0.90 or lower extremity ultrasound vascular stenosis > 50%).
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 |
|---|---|---|
| Xuebi formula | Drug | Xuebi formula |
| placebo | Drug | Placebo |
Primary outcome
Change in Scores of TCM clinical symptom and the clinical scoring system of Toronto (TCSS)
Time frame: 24weeks
1. Scores of TCM clinical symptom. Using statistical table score, main symptoms and secondary symptoms according to the degree is divided into light, medium, heavy, the main symptoms were recorded 2, 4, 6 points, the secondary symptoms were recorded 1, 2, 3 points. No symptomatic record 0 points. Before the study, of 4, 8, 12, 16, 20, 24 week each recorded 1 times. Description of tongue and pulse only, not scoring. 2. the clinical scoring system of Toronto (TCSS). TCSS includes a score of neural symptoms, nerve reflex scores and sensory examination , a total of 19 points.Before the study, of 4, 8, 12, 16, 20, 24 week each scoring 1 times.According to the classification standard, 0-5 points does not have DPN, 6-8 points for mild DPN, 9-11 points for moderate DPN, 12-19 points for severe DPN.
1 secondary outcome
Change in Nerve conduction velocity
Time frame: 24Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
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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.
Xiaolin Tong, PHD study chair
Guang'anmen Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Xuebi formula in people with Diabetic Peripheral Neuropathy and Diabetes, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
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 0 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact qiang zhou, PHD (15101016416 ext. 0086, 15101016416@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Scores of TCM clinical symptom and the clinical scoring system of Toronto (TCSS) (time frame: 24weeks). 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 17 Jan 2014.