A Study of Xuebi Formula for Diabetic Peripheral Neuropathy(Qi-deficiency and Blood-stasis) (XB)

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)

Study Overview

• Status: Unknown
• Conditions: Diabetes; Diabetic Peripheral Neuropathy; Chinese Herbs
• Intervention / Treatment: Drug: placebo; Drug: Xuebi formula

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xuebi formula; Xuebi formula , one dosage ,every day, treat 6 months.	Drug: Xuebi formula
Placebo Comparator: Placebo; placebo,has the same taste and color as Xuebi formula one dosage ,every day, treat 6 months.	Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Nerve conduction velocity	Nerve conduction velocity are recorded at 0,12th,24th weeks.	24Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	Adverse events with records at any time.	24Weeks

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Study Chair: Xiaolin Tong, PHD, Guang'anmen hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: December 8, 2013
• First Submitted That Met QC Criteria: January 15, 2014
• First Posted (Estimate): January 17, 2014

Study Record Updates

• Last Update Posted (Estimate): January 17, 2014
• Last Update Submitted That Met QC Criteria: January 15, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: 20131205