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

Diabetes Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02039544
• Other study ID #: 20131205
• Status: Not yet recruiting
• Phase: N/A
• First received: December 8, 2013
• Last updated: January 15, 2014
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: January 2014
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: qiang zhou, PHD
• Phone: 15101016416
• Email: 15101016416[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

• 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chinese Herbs
• Diabetes
• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• Xuebi formula

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events	Adverse events with records at any time.	24Weeks	Yes
Primary	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	No
Secondary	Change in Nerve conduction velocity	Nerve conduction velocity are recorded at 0,12th,24th weeks.	24Weeks	No