A Study of Xuebi Formula for Diabetic Peripheral Neuropathy(Qi-deficiency and Blood-stasis) (XB)
Primary Purpose
Diabetic Peripheral Neuropathy, Diabetes, Chinese Herbs
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Xuebi formula
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy
Eligibility Criteria
- according to the 1999 WHO criteria, in accordance with the diagnostic criteria for type 2 diabetes.
- according to the diagnostic standard of diabetes peripheral nerve lesions.
- age range 30-70 years.
- Syndrome of traditional Chinese medicine is Qi deficiency and blood stasis.
- FBG < 13.9mmol/L, HbA1c<10%.
- signed the informed consent
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Xuebi formula
Placebo
Arm Description
Xuebi formula , one dosage ,every day, treat 6 months.
placebo,has the same taste and color as Xuebi formula one dosage ,every day, treat 6 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Nerve conduction velocity
Nerve conduction velocity are recorded at 0,12th,24th weeks.
Full Information
NCT ID
NCT02039544
First Posted
December 8, 2013
Last Updated
January 15, 2014
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02039544
Brief Title
A Study of Xuebi Formula for Diabetic Peripheral Neuropathy(Qi-deficiency and Blood-stasis)
Acronym
XB
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy, Diabetes, Chinese Herbs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Xuebi formula
Arm Type
Experimental
Arm Description
Xuebi formula , one dosage ,every day, treat 6 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo,has the same taste and color as Xuebi formula one dosage ,every day, treat 6 months.
Intervention Type
Drug
Intervention Name(s)
Xuebi formula
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change in Scores of TCM clinical symptom and the clinical scoring system of Toronto (TCSS)
Description
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.
Time Frame
24weeks
Secondary Outcome Measure Information:
Title
Change in Nerve conduction velocity
Description
Nerve conduction velocity are recorded at 0,12th,24th weeks.
Time Frame
24Weeks
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events
Description
Adverse events with records at any time.
Time Frame
24Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
according to the 1999 WHO criteria, in accordance with the diagnostic criteria for type 2 diabetes.
according to the diagnostic standard of diabetes peripheral nerve lesions.
age range 30-70 years.
Syndrome of traditional Chinese medicine is Qi deficiency and blood stasis.
FBG < 13.9mmol/L, HbA1c<10%.
signed the informed consent
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
qiang zhou, PHD
Phone
15101016416
Ext
0086
Email
15101016416@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolin Tong, PHD
Organizational Affiliation
Guang'anmen Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
A Study of Xuebi Formula for Diabetic Peripheral Neuropathy(Qi-deficiency and Blood-stasis)
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