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This is an open-label, randomized, multi-center clinical trial to evaluate the safety and efficacy in peripheral neuropathies patients treated with Mecobalamin Injection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Diabetic Peripheral Neuropathy (IV) | Experimental |
| |
| Group B: Diabetic Peripheral Neuropathy (IM) | Experimental |
| |
| Group C: Idiopathic Peripheral Neuropathy | Experimental |
| |
| Group D: Nutritional & Metabolic Peripheral Neuropathy | Experimental |
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| Group E: Compression Peripheral Neuropathy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mecobalamin IV Injection | Drug | Mecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline | The TSS of peripheral neuropathy is used to score the intensity & frequency of four symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment. | Baseline & End of Week 4 |
| Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline | TSS of peripheral neuropathy is used to score the intensity & frequency of 4 symptoms in participants' feet/legs including: pain, burning sensation, numbness, hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline scores were compared to TSS decreasing rate after 4 weeks of treatment. Rate of TSS change = (TSS difference value/TSS before treatment)×100%. | Baseline and End of Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline | The TSS of peripheral neuropathy is used to score the intensity & frequency of four symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline (before treatment) scores were compared to scores after 2 weeks of treatment. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jvming Lu | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 1st Hospital of Anhui Medical University | Hefei | Anhui | China | |||
| The General Hospital of the People's Liberation Army |
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| Mecobalamin IM injection | Drug | Mecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks |
|
| Mecobalamin IV or IM injection | Drug | Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks |
|
| Baseline and End of Week 2 |
| Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline | TSS of peripheral neuropathy is used to score the intensity/ frequency of 4 symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline scores were compared to TSS decreasing rate after 2 weeks of treatment. Rate of TSS change = (TSS difference value/TSS before treatment)×100%. | Baseline and End of Week 2 |
| Value of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline | The Neural Injury Score of the Lower Limbs (NIS-LL) was scored based on the following examination items: muscle strength (including hip & knee flexion/ extension & remote foot dorsiflexion/ plantar flexion [scored as normal, 25% weak, 50% weak, 75% weak, and paralysis]), reflex (response at the quadriceps & ankle [normal score=0, decreased score=1, absent score=2], and sensory (tested at the great toe; including touch pressure, pinprick ,vibration, and joint position [normal score=0, decreased score=1, absent score=2]). The Total NIS-LL score ranged from 0-8 points where a higher score means greater neural injury of the lower limbs. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment. | Baseline and End of Week 4 |
| Rate of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline | The Neural Injury Score of the Lower Limbs (NIS-LL) was scored based on the following examination items: muscle strength (including hip & knee flexion/ extension & remote foot dorsiflexion/ plantar flexion [scored as normal, 25% weak, 50% weak, 75% weak, and paralysis]), reflex (response at the quadriceps & ankle [normal score=0, decreased score=1, absent score=2], and sensory (tested at the great toe; including touch pressure, pinprick ,vibration, and joint position [normal score=0, decreased score=1, absent score=2]). The Total NIS-LL score ranged from 0-8 points where a higher score means greater neural injury of the lower limbs. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment. Rate of NIS-LL change = (NIS-LL difference value/NIS-LL before treatment)×100%. | Baseline and End of Week 4 |
| Beijing |
| Beijing Municipality |
| China |
| The institute of rehabilitation medicine | Beijing | Beijing Municipality | China |
| Nanfang Hospital of Nanfang Medical Unversity | Guangzhou | Guangdong | China |
| The 1st People Hospital of Guangzhou | Guangzhou | Guangdong | China |
| the 1st Hospital affliated to Guangxi Medical University | Nanning | Guangxi | China |
| The 3rd Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| the people Hospital | Wuhan | Hubei | China |
| Tongji Hospital | Wuhan | Hubei | China |
| Xiehe Hospital | Wuhan | Hubei | China |
| the 1st Hospital of Nanjing | Nanjing | Jiangsu | China |
| Zhong Xi Yi Jie He Hospital of Jiangsu | Nanjing | Jiangsu | China |
| the 2nd Hospital of Suzhou University | Suzhou | Jiangsu | China |
| Subei People Hospital | Yangzhou | Jiangsu | China |
| The 1st People Hospital of Yangzhou | Yangzhou | Jiangsu | China |
| the Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| Changhai Hospital | Shanghai | Shanghai Municipality | China |
| Ruijing Hospital | Shanghai | Shanghai Municipality | China |
| the 10th People Hospital of Shanghai | Shanghai | Shanghai Municipality | China |
| the 10th People Hospital | Shanghai | Shanghai Municipality | China |
| The 1st Center Hospital of Tianjin | Tianjin | Tianjin Municipality | China |
| The institute of rehabilitation medicine | Beijing | China |
| Rui Jin Hospital | Shanghai | China |
| Shenzhen Hospital of Beijing University | Shenzhen | China |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007273 | Injections, Intramuscular |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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