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

Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT02039544
Collaborator
(none)
60
Enrollment
2
Arms
15.9
Duration (Months)

Study Details

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)

Condition or Disease Intervention/Treatment Phase
  • Drug: Xuebi formula
  • Drug: placebo
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Jan 1, 2015
Anticipated Study Completion Date :
May 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Scores of TCM clinical symptom and the clinical scoring system of Toronto (TCSS) [24weeks]

    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

  1. Change in Nerve conduction velocity [24Weeks]

    Nerve conduction velocity are recorded at 0,12th,24th weeks.

Other Outcome Measures

  1. Number of participants with adverse events [24Weeks]

    Adverse events with records at any time.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

  • Study Chair: Xiaolin Tong, PHD, Guang'anmen Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fengmei Lian, chair, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT02039544
Other Study ID Numbers:
  • 20131205
First Posted:
Jan 17, 2014
Last Update Posted:
Jan 17, 2014
Last Verified:
Jan 1, 2014
Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies

Study Results

No Results Posted as of Jan 17, 2014