PMID- 34093204
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210608
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 12
DP  - 2021
TI  - 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.
PG  - 676503
LID - 10.3389/fphar.2021.676503 [doi]
LID - 676503
AB  - Background: Diabetic peripheral neuropathy (DPN) characterized by nerve damage is 
      a common and disabling chronic microvascular complication in patients with type 2 
      diabetic mellitus (T2DM), affecting at least half of patients diagnosed with 
      T2DM. Unfortunately, the current treatment for DPN is not ideal. Traditional 
      Chinese medicine (TCM), with a unique theoretical system, has made outstanding 
      contributions in the treatment of T2DM and related complications. Mudan granule, 
      a Chinese patent medicine, has been previously validated that could ameliorate 
      the symptoms, promote nerve tissue repair, increase nerve conduction velocity 
      (NCV) in patients with DPN. However, the previous studies are of variable 
      quality, which limits the clinical application of Mudan granule. Therefore, we 
      designed a double-blind, randomized, placebo-controlled, parallel-arm, 
      multi-center trial to estimate the safety and efficacy of Mudan granule in 
      conjunction with methylcobalamin in individuals suffering from type 2 diabetic 
      peripheral neuropathy. Methods: This work is conducted as a 14-center, 
      double-blind, randomized, placebo-controlled, parallel-arm trial. In all, 402 
      subjects (aged 30-70 years) will be recruited and randomized in a 1:1 ratio to an 
      intervention group (n = 201; Mudan granule + methylcobalamin) and a control group 
      (n = 201; placebo + methylcobalamin). Treatment is administered in 24 weeks 
      cycles without any treatment interruption between cycles. Michigan Diabetic 
      Neuropathy Score (MDNS) as the primary outcome will be evaluated at baseline, 
      12 weeks during the intervention period, and after 24 weeks of the intervention. 
      Adverse events and safety assessments will be also documented. The analysis of 
      all data will be carried out based on a predefined statistical analysis plan. 
      Discussion: The outcomes from this study will offer important evidence regarding 
      the safety and efficacy that Mudan granule can be used as an alternative and 
      complementary therapeutic intervention in patients with type 2 diabetic 
      peripheral neuropathy. Clinical trial registration: Registered at 
      https://clinicaltrials.gov/. Trial registration number: NCT04711980. Registered 
      January 2021.
CI  - Copyright (c) 2021 Zhang, Jin, Duan, Hao, Chen, Yu, Lian and Tong.
FAU - Zhang, Yuehong
AU  - Zhang Y
AD  - Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese 
      Medical Sciences, Beijing, China.
FAU - Jin, De
AU  - Jin D
AD  - Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese 
      Medical Sciences, Beijing, China.
FAU - Duan, Yingying
AU  - Duan Y
AD  - Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese 
      Medical Sciences, Beijing, China.
AD  - School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, 
      Beijing, China.
FAU - Hao, Rui
AU  - Hao R
AD  - Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese 
      Medical Sciences, Beijing, China.
FAU - Chen, Keyu
AU  - Chen K
AD  - Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese 
      Medical Sciences, Beijing, China.
AD  - School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, 
      Beijing, China.
FAU - Yu, Tongyue
AU  - Yu T
AD  - Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese 
      Medical Sciences, Beijing, China.
FAU - Lian, Fengmei
AU  - Lian F
AD  - Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese 
      Medical Sciences, Beijing, China.
FAU - Tong, Xiaolin
AU  - Tong X
AD  - Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese 
      Medical Sciences, Beijing, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT04711980
PT  - Journal Article
DEP - 20210520
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC8173202
OTO - NOTNLM
OT  - Chinese patent medicine
OT  - efficacy
OT  - mudan granule
OT  - study protocol
OT  - type 2 diabetic peripheral neuropathy
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2021/06/08 06:00
MHDA- 2021/06/08 06:01
PMCR- 2021/05/20
CRDT- 2021/06/07 05:49
PHST- 2021/03/05 00:00 [received]
PHST- 2021/05/04 00:00 [accepted]
PHST- 2021/06/07 05:49 [entrez]
PHST- 2021/06/08 06:00 [pubmed]
PHST- 2021/06/08 06:01 [medline]
PHST- 2021/05/20 00:00 [pmc-release]
AID - 676503 [pii]
AID - 10.3389/fphar.2021.676503 [doi]
PST - epublish
SO  - Front Pharmacol. 2021 May 20;12:676503. doi: 10.3389/fphar.2021.676503. 
      eCollection 2021.