Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy

NCT ID: NCT03983200

Last Updated: 2019-06-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2019-12-31

Brief Summary

The aim of the study is to assess the effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy using Nerve conduction velocity examination.

Conditions

Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Mecobalamine 0.5mg, tid

Group Type: SHAM_COMPARATOR

Mecobalamin

Intervention Type: DRUG

mecobalamine 0.5mg,tid

Rotating Magnetic Therapy

Rotating Magnetic Therapy 30min,bid + Mecobalamine 0.5mg, tid

Group Type: EXPERIMENTAL

Rotating Magnetic Therapy

Intervention Type: DEVICE

Rotating Magnetic Therapy 30min, bid

Mecobalamin

Intervention Type: DRUG

mecobalamine 0.5mg,tid

Interventions

Rotating Magnetic Therapy

Rotating Magnetic Therapy 30min, bid

Intervention Type: DEVICE

Mecobalamin

mecobalamine 0.5mg,tid

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Volunteer to participate and sign informed consent prior to the study 2. Patients with type 2 diabetes, who met WHO1999 diagnostic criteria, had diabetes distal symmetrical multiple neuropathy (1) clear history of diabetes; (2) neuropathy at or after diagnosis of diabetes;(3) clinical manifestations and signs are consistent with DPN;(4) have clinical symptoms (pain, numbness, paresthesia, etc.), 5 examination (ankle reflex, acupuncture pain sense, vibration sense, pressure sense, temperature sense) any 1 abnormal;If there were no clinical symptoms, 2 of the 5 examinations were abnormal.(5) exclude other causes of neuropathy).

3. HbA1c<7.5%, the hypoglycemic regimen was stable for 3 months 4. No acute complications, such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.

Exclusion Criteria

• 1. Patients with foreign metal bodies or pacemakers 2. Patients with a history of surgery at magnetic therapy sites within one year 3. Patients with obvious discomfort to magnetic therapy 4. Patients with bleeding or bleeding tendency 5. Patients with acute complications such as diabetic ketoacidosis 6. Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal 7. History of drug abuse and alcohol dependence in the past 5 years 8. Systemic hormone therapy was used in the last three months 9. Patients with infection and stress within 4 weeks 10. Patients who are pregnant, breast-feeding, or intending to become pregnant. 11. Any other obvious conditions or co-existing diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors, other pancreatic diseases, patients with a history of mental illness, or severe wasting diseases

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Majianhua

OTHER

Sponsor Role: lead

Responsible Party

Majianhua

Director, Head of Endocrinology department, Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

KY20190530-04

Identifier Type: -

Identifier Source: org_study_id