Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy

NCT03983200 | Unknown

• 1 other identifier: KY20190530-04
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Nerve conduction velocity examination

  the change of Nerve conduction velocity examination

  1 month

Secondary Outcomes (2)

• MNSI

  1 month

• Glycosylated serum albumin

  1 month

Study Arms (2)

Control group

SHAM COMPARATOR

Mecobalamine 0.5mg, tid

Drug: Mecobalamin

Rotating Magnetic Therapy

EXPERIMENTAL

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

Device: Rotating Magnetic Therapy; Drug: Mecobalamin

Interventions

Rotating Magnetic Therapy DEVICE

Rotating Magnetic Therapy 30min, bid

Rotating Magnetic Therapy

Mecobalamin DRUG

mecobalamine 0.5mg,tid

Control group; Rotating Magnetic Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Majianhua: lead

MeSH Terms

Interventions

mecobalamin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Endocrinology department, Clinical Professor

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: June 15, 2019
• Primary Completion: November 15, 2019
• Study Completion: December 31, 2019
• Last Updated: June 17, 2019

Record last verified: 2019-06