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| ID | Type | Description | Link |
|---|---|---|---|
| HP2024-03-501004 | Other Grant/Funding Number | 2024 Haidian District Health and Wellness Development Research Incubation Program |
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The evaluation for efficacy and safety of needle-free subcutaneous injector and conventional intramuscular injection of mecobalamin for diabetic neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| needle free subcutaneous injector of mecobalamin | Active Comparator |
| |
| intramuscular injection of Mecbl | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| needle-free subcutaneous injector for Mecbl | Other | needle-free subcutaneous injector for Mecbl |
|
| Measure | Description | Time Frame |
|---|---|---|
| concentration of plasma vitamin B12 | The plasma vitamin B12, biomarker for effective active metabolite for neural repair. | baseline, half an hour, first hour, second hour, 8 weeks |
| corneal confocal microscopy parameter: inferior whorl length | The corneal nerve fiber length in inferior whorl area. | baseline, 8 weeks |
| corneal confocal microscopy parameter: corneal nerve fiber length | The corneal nerve fiber length per frame. | baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| neurological function scales score: the modified Toronto clinical neuropathy score (mTCNS) | mTCNS is a valid and reliable scale for staging of mild to moderate diabetic sensorimotor polyneuropathy. Value of 3 or more is recommended for the diagnosis of peripheral neuropathy. | baseline, 8 weeks |
| neurological function scales score: Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) |
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Inclusion Criteria:
Exclusion Criteria:
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| intramuscular injection of Mecbl | Other | intramuscular injection of Mecbl |
|
A patient-reported outcomes measure reflecting small fiber, physical functioning/large fiber neuropathy, autonomic nerve function, symptoms, and activities of daily living. Ranges from -4 to 136, higher score indicates worse QOL. |
| baseline, 8 weeks |
| neurological function scales score: Neuropathy Impairment Score (NIS) | Clinician assessments about cranial nerves and limbs for muscle weakness, sensation loss, and decreased reflexes. ranges from 0 to 244. Higher NIS reflect greater neuropathic impairment. | baseline, 8 weeks |
| neurological function scales score: Neuropathy Impairment Score of the lower limbs plus seven tests (NIS(LL)+7 tests) | Neuropathy impairment score of the lower limbs plus seven tests includes muscle weakness, sensation loss, and decreased reflexes. Ranges from 0 to 88. More NIS-LL scores indicate greater neuropathic impairment. | baseline, 8 weeks |
| neurological function scales score: Polyneuropathy disability (PND) score | Polyneuropathy disability grades of walking. 0-IV grades were measured. More score is more severe impairment. | baseline, 8 weeks |
| neurological function scales score: DNS score | Score items are unsteadiness of gait, burning or aching sensation, pricking sensation and numbness. A score of one or more denotes the presence of neuropathy. | baseline, 8 weeks |
| neurological function scales score: NDS score | Evaluation of pinprick sensation, vibration sensation and temperature sensation. A total of 10 points was adopted. A score of 6 - 8 denotes the presence of moderate DPN, and a score of 9 - 10 denotes severe DPN. | baseline, 8 weeks |
| neuroelectrophysiological parameter: NCV | Nerve conduction latency | baseline, 8 weeks |
| neuroelectrophysiological parameter: NCV | Nerve conduction velocity | baseline, 8 weeks |
| neuroelectrophysiological parameter: NCV | Nerve conduction wave amplitude | baseline, 8 weeks |
| neuroelectrophysiological parameter: SSR | Velocity of sympathetic skin response | baseline, 8 weeks |
| neuroelectrophysiological parameter: SSR | Amplitude of sympathetic skin response | baseline, 8 weeks |
| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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