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Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rotating Magnetic Therapy
Mecobalamin
Sponsored by
Majianhua
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Control group

    Rotating Magnetic Therapy

    Arm Description

    Mecobalamine 0.5mg, tid

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

    Outcomes

    Primary Outcome Measures

    Nerve conduction velocity examination
    the change of Nerve conduction velocity examination

    Secondary Outcome Measures

    MNSI
    Michigan Neuropathy Screening Instrument
    Glycosylated serum albumin
    the change of Glycosylated serum albumin

    Full Information

    First Posted
    June 10, 2019
    Last Updated
    June 13, 2019
    Sponsor
    Majianhua
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03983200
    Brief Title
    Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy
    Official Title
    Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 15, 2019 (Anticipated)
    Primary Completion Date
    November 15, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Majianhua

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Peripheral Neuropathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Arm Description
    Mecobalamine 0.5mg, tid
    Arm Title
    Rotating Magnetic Therapy
    Arm Type
    Experimental
    Arm Description
    Rotating Magnetic Therapy 30min,bid + Mecobalamine 0.5mg, tid
    Intervention Type
    Device
    Intervention Name(s)
    Rotating Magnetic Therapy
    Intervention Description
    Rotating Magnetic Therapy 30min, bid
    Intervention Type
    Drug
    Intervention Name(s)
    Mecobalamin
    Intervention Description
    mecobalamine 0.5mg,tid
    Primary Outcome Measure Information:
    Title
    Nerve conduction velocity examination
    Description
    the change of Nerve conduction velocity examination
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    MNSI
    Description
    Michigan Neuropathy Screening Instrument
    Time Frame
    1 month
    Title
    Glycosylated serum albumin
    Description
    the change of Glycosylated serum albumin
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

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    Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy

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