Post-marketing Evaluation of Mudan Granule Intervention on Type 2 Diabetic Peripheral Neuropathy
NCT ID: NCT04711980
Last Updated: 2021-01-15
Study Results
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Basic Information
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UNKNOWN
EARLY_PHASE1
402 participants
INTERVENTIONAL
2021-06-30
2022-09-30
Brief Summary
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Methods and design: A randomized, double-blind, placebo-controlled,parallel-arm, and multi-centric clinical trial design was used based on a co-regimen of methylcobalamin. Subjects who met the inclusion criteria were randomly divided into two groups. The patients in the study group were treated with Mudan granule combined with methylcobalamin, and the patients in the control group were treated with placebo combined with methylcobalamin. The total intervention period is 24 weeks. The sample size was 402 cases.
Major evaluation indicators: Michigan Diabetic Neuropathy Score (MDNS) changes, the changes of MDNS were compared between the two groups before and after medication, adopting the evaluation method of difference values. Secondary Evaluation Indicators:(1) nerve conduction velocity changes, the changes in nerve conduction velocity of each nerve were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (2)corneal nerve fiber density changes, the changes in corneal nerve fiber density of each mm2 were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (3)corneal nerve branch density changes, the changes in corneal nerve branch density of each mm2 were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (4)corneal nerve fiber length changes, the changes in corneal nerve fiber length of each mm2 were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (5)Toronto Clinical Scoring System (TCSS) changes, the changes of toronto clinical score were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (6)Traditional Chinese Medicine(TCM) syndromes efficacy score changes, the changes in TCM syndromes efficacy score were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (7) Clinical symptoms score changes, the changes of each of clinical symptoms score were compared between the two groups before and after medication, adopting the evaluation method of difference values.
Discussion: We postulate that patients with type 2 diabetic peripheral neuropathy will benefit from therapy with Mudan granule.
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Detailed Description
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2. Experimental Measures and contrast: A randomized, double-blind, placebo-controlled,parallel- arm,and multi-centric clinical trial design was used on the basis of a co-regimen of methylcobalamin.The patients in the study group were treated with Mudan granule (7g 3 times/day for 24 weeks)and patients were treated with placebo (7g 3 times/day for 24 weeks) in the control group.The sample size was determined to 402 cases through statistics calculation.
Sample size calculation basis: According to the previous study of Mudan granule combined with methylcobalamin in the treatment of DPN with 12 weeks intervention, the results of the MDNS indicated that the study group (Mudan granule + methylcobalamin) scale score was 5.48±1.19, and the control group (placebo + methylcobalamin) scale score was 8.21 ±1.24, and the mean difference between the two groups was 2.73;Assuming that Mudan granule combined with methylcobalamin in the treatment of DPN can reduce the MDNS by 0.58 after 12 weeks of intervention, it is considered better than the control group.Taking α=0.05, β=0.10, the study group and the control group with 24 weeks intervention were allocated at a ratio of 1:1. The sample size calculated by the Power Analysis and Sample Size (PASS) 11 software was not less than 167 cases in each group. Considering no more than 20% withdrawal rate, the total number of cases is 402, 201cases in each group.
3. Research design 3.1 This trial was designed as a randomized, double-blind, placebo-controlled,parallel-arm, and multi-centric clinical trial. Subjects who met the inclusion criteria were randomly divided into two groups. The patients in the study group were treated with Mudan granule combined with methylcobalamin , and the patients in the control group were treated with placebo combined with methylcobalamin. The sample size was 402 cases.
3.2 The total intervention period is 24 weeks. 3.3 Curative effect evaluation criteria 3.3.1 Major evaluation indicators Changes in total score on the Michigan Diabetic Neuropathy Score (MDNS) of Scale,MDNS was recorded on the Michigan Diabetic Neuropathy Score of Scale. The changes of MDNS were compared between the two groups before and after medication, adopting the evaluation method of difference values. The total score was 46, ranging from 0 (least severe) to 46 (most severe).
3.3.2 Secondary Evaluation Indicators
1. Changes in nerve conduction velocity,the changes in nerve conduction velocity of each nerve were compared between the two groups before and after taking medicine,adopting the evaluation method of difference values.
2. Changes in corneal nerve fiber density of each mm2,the changes in corneal nerve fiber density of each mm2 were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values.
3. Changes in corneal nerve branch density of each mm2,the changes in corneal nerve branch density of each mm2 were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values.
4. Changes in corneal nerve fiber length of each mm2,the changes in corneal nerve fiber length of each mm2 were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values.
5. Changes in total score on the Toronto Clinical Scoring System (TCSS) of Scale,toronto clinical score was recorded on the Toronto Clinical Scoring System(TCSS) of Scale. The changes of toronto clinical score were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. The total score was 19, ranging from 0 (least severe) to 19 (most severe).
6. Evaluation criteria of Traditional Chinese Medicine(TCM) syndromes efficacy score
①Clinical cure:TCM syndrome efficacy score reduced ≥90%.②Markedly effective: 90%\>TCM syndrome efficacy score ≥70%.③Valid: 30% ≤ TCM syndrome efficacy score \< 70%.④Invalid: TCM syndrome efficacy score reduced \<30%.
7. Evaluation criteria of clinical symptoms score ①Disappearance: the symptoms disappeared,and the score was 0.②Improvement: the symptoms were relieved,and the score was reduced but not 0.③No improvement: the symptoms remained unchanged, and the score did not change.④Exacerbation: the symptoms exacerbated and the score increased.
3.4 Observation indicators
1. Demographic and clinical data:gender, age, disease course, family history,past medical history and so on (0 week).
2. Curative effect indicators：Michigan Diabetic Neuropathy Score (MDNS) (0,12,24weeks),nerve conduction velocity (0 weeks, 24 weeks),corneal nerve fiber parameters (0,24 weeks),Toronto Clinical Scoring System (TCSS) (0,12,24 weeks),TCM syndromes efficacy (0,4,8,12,16,20,24 weeks).
3. Monitoring indicators
* Fasting blood glucose, blood pressure (0,4,8,12,16,20,24 weeks).
* Glycated hemoglobin, blood lipid (0, 12, 24 weeks).
4. Safety indicators
①Adverse events (recorded in detail at any time).
②General vital signs:body temperature, heart rate, respiration and so on(0, 4, 8, 12, 16, 20, 24 weeks).
③Blood routine, urine routine, urine pregnancy test, stool routine, 12-lead Electrocardiography, liver and kidney function test (0, 12, 24 weeks).
3.5 Basic treatment
* Diabetes education.
* Diabetic diet. ③Rational control of blood glucose: using oral hypoglycemic agents or insulin injections to keep all patients' blood glucose stable in the study. In principle, the type and dose of hypoglycemic agents should maintain unchanged. If fasting blood glucose fluctuates more than 20%,diabetes experts need to find and eliminate the predisposing factors as soon as possible, adjust the dose and monitor the blood glucose changes, so as to keep the blood glucose stable within 4 weeks.Adjusted dose of the drug needs to be detailed recorded in the combined medication table.
* Taking methylcobalamin tablets (0.5mg,3 times/d). (Eisai (China) Pharmaceutical Co., Ltd.).
3.6 Provisions for combined treatment
①All Chinese herbal medicines with the same efficacy as the study drug (including Chinese herbal medicines with similar therapeutic indications and Chinese herbal medicines with similar efficacy) were banned during the study period.
②Besides methylcobalamin, drugs such as alpha lipoic acid, epalrestat, and VitB12 for the treatment of diabetic peripheral neuropathy are prohibited.
③All combination therapy and treatment (treatment measure or treatment medicine of other diseases) should be documented in the combined medication table.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Mudan granule
Based on the standard medical care, experimental group were treated with Mudan Granule 7g , 3 times/d.
Intervention: Drug: Mudan granule
Mudan granule
Mudan granule,a traditional Chinese medicine formula,consists of nine Chinese herbs.
Other: Standard medical care.Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).
Placebo
Based on the standard medical care, placebo-controlled group were treated with Placebo 7g , 3 times/d Intervention: Drug: Placebo
Placebo
Granule(Placebo) is in accordance with Mudan granule in appearance, colour, taste.
Other: Standard medical care. Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).
Interventions
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Mudan granule
Mudan granule,a traditional Chinese medicine formula,consists of nine Chinese herbs.
Other: Standard medical care.Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).
Placebo
Granule(Placebo) is in accordance with Mudan granule in appearance, colour, taste.
Other: Standard medical care. Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Meet the diagnostic criteria of TCM syndrome differentiation of qi deficiency and collaterals obstruction.
3. The patient's age is between 30-70 years.
4. At least 2 nerve conduction velocities have decreased on electromyography.
5. Sign informed consent.
Exclusion Criteria
2. Besides methylcobalamin,the drugs such as alpha lipoic acid, epalrestat, VitB12, Chinese patent medicine and decoction have been used to treat diabetic peripheral neuropathy within 4 weeks before enrollment.
3. Systolic blood pressure \> 160 millimeters of mercury (mmHg) or diastolic blood pressure \> 100mmHg.
4. Having the diabetic ketoacidosis, ketoacidosis and severe infection within one month.
5. Combined with cardiovascular, liver, kidney and hematopoietic system and other serious primary disease, serum transaminase beyond the normal value more than 2 times, serum creatinine greater than the upper limit of normal, psychiatric patients.
6. Pregnancy, prepared to pregnant or lactating women.
7. Having a history of multiple drug allergies or being allergic to the ingredients of Mudan granule.
8. Participate in other clinical studies within one month.
9. Drinking alcohol excessive and/or taking psychoactive substances, drug abusers and dependents over the past five years.
10. Having a history of active ophthalmopathy,ocular surgery,glaucoma,acute and chronic corneal diseases,extended-wearing contact lens and so on.
30 Years
70 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Beijing Hospital
OTHER_GOV
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Chengdu University of Traditional Chinese Medicine
OTHER
The Fourth People's Hospital of Chongqing
UNKNOWN
Zhengzhou Yihe Hospital Affiliated to Henan University
UNKNOWN
Zhu Xianyi Memorial Hospital of Tianjin Medical University
UNKNOWN
The Third Hospital of Xi'an
UNKNOWN
Huashan Hospital
OTHER
Gansu Provincial People's Hospital
UNKNOWN
Shenzhen Hospital of Guangzhou University of Traditional Chinese Medicine
UNKNOWN
Affiliated Hospital of Changchun University of Chinese Medicine
OTHER
Fengmei Lian
OTHER
Responsible Party
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Fengmei Lian
chief physician, Professor, endocrinology department of Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Principal Investigators
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Xin hua Xiao, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Yi Li, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Hospital
Shi jia Yu, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Yan gang Wang, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Qingdao University
Qiu Chen, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chengdu University of Traditional Chinese Medicine
Wu quan Deng, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Fourth People's Hospital of Chongqing
Zhi gang Zhao, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Zhengzhou Yihe Hospital Affiliated to Henan University
Zhen qiang Song, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Zhu Xianyi Memorial Hospital of Tianjin Medical University
Ping Liu, Master
Role: PRINCIPAL_INVESTIGATOR
The Third Hospital of Xi'an
Yi ming Li, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Jing Liu, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Gansu Provincial People's Hospital
Chun Li Piao, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Hospital of Guangzhou University of Traditional Chinese Medicine
Xiu ge Wang, Master
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Changchun University of Chinese Medicine
Locations
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Zhang Y, Jin D, Duan Y, Hao R, Chen K, Yu T, Lian F, Tong X. Efficacy of Mudan Granule (Combined With Methylcobalamin) on Type 2 Diabetic Peripheral Neuropathy: Study Protocol for a Double-Blind, Randomized, Placebo-Controlled, Parallel-Arm, Multi-Center Trial. Front Pharmacol. 2021 May 20;12:676503. doi: 10.3389/fphar.2021.676503. eCollection 2021.
Other Identifiers
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2020 Mudan Granule
Identifier Type: -
Identifier Source: org_study_id
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