Long-term effect of Chinese herbal medicine Tianqi Capsule on the incidence of diabetes: an 8-year cohort study protocol

Background: The rapid growth of type 2 diabetes mellitus (T2DM) remains a big challenge for clinicians worldwide. Traditional Chinese medicine may bring a new approach for solving this problem. The Tianqi Capsule Diabetes Prevention Study (REDUCES Study) reported that 1 years of therapy with Tianqi...

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Main Authors: Bing Pang, Chun-Yong Han, Qing-Hu He, Jing Liu, Qing-Wei Li, Yu-Jiao Zheng, Feng-Mei Lian, Xiao-Lin Tong
Format: Article
Language:English
Published: Hong Kong Gold Orchid Science and Technology Co., Limited 2018-07-01
Series:Traditional Medicine Research
Subjects:
Online Access:http://www.tmrjournal.com/EN/10.12032/TMR201812075
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spelling doaj-ae45402a16bf4f43a1ff1be433ba1c8f2020-11-24T23:12:20ZengHong Kong Gold Orchid Science and Technology Co., LimitedTraditional Medicine Research2413-39732413-39732018-07-013416617210.12032/TMR201812075Long-term effect of Chinese herbal medicine Tianqi Capsule on the incidence of diabetes: an 8-year cohort study protocolBing Pang0Chun-Yong Han1Qing-Hu He2Jing Liu3Qing-Wei Li4Yu-Jiao Zheng5Feng-Mei Lian6Xiao-Lin Tong7Department of Endocrinology, Guang’anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, ChinaSinobioway Group Co., Ltd., Heilongjiang Tian Ren Pharmarceutical Co., Ltd, Heilongjiang, China. 3 Hunan University of Traditional Chinese Medicine, Hunan, China Hunan University of Traditional Chinese Medicine, Hunan, ChinaSinobioway Group Co., Ltd., Heilongjiang Tian Ren Pharmarceutical Co., Ltd, Heilongjiang, China. 3 Hunan University of Traditional Chinese Medicine, Hunan, ChinaDepartment of Endocrinology, Guang’anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, ChinaDepartment of Endocrinology, Guang’anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, ChinaDepartment of Endocrinology, Guang’anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, ChinaDepartment of Endocrinology, Guang’anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, ChinaBackground: The rapid growth of type 2 diabetes mellitus (T2DM) remains a big challenge for clinicians worldwide. Traditional Chinese medicine may bring a new approach for solving this problem. The Tianqi Capsule Diabetes Prevention Study (REDUCES Study) reported that 1 years of therapy with Tianqi capsule reduced the risk of diabetes by 32.1% compared with the placebo. Here we aimed to assess the long-term effect of Tianqi capsule on prevention of T2DM in people with impaired glucose tolerance after discontinuation of active intervention. Methods/design: 420 subjects will be followed-up for 8 years to assess the long-term effect of Tianqi capsule intervention. The causes of death and the status of living subjects will be investigated. Follow-up data for living subjects will be collected by personal interview and clinical examination and medical record review to determine diabetes status. Questionnaires will be given to all the subjects to investigate the factors that probably affect the diabetes status during the 8-year of discontinuation of intervention. The primary outcome is the incidence of T2DM, and the secondary outcomes are body mass index, blood glucose, blood lipids and blood pressure. The Cox proportional hazards model will be used to estimate the hazard ratio for diabetes incidence. Analyses will be done with SAS 8.2 software package. Discussion: Results from this study may provide evidence for the long-term efficacy of Tianqi capsule in patients with prediabetes. The findings will provide a basis for further confirmatory studies. Ethics: The protocol has been approved by the Medical Ethics Committee of Guang’anmen Hospital of China Academy of Chinese Medical Sciences (approval number 2016-046-KY-01). Study registration number: ClinicalTrials.gov; NCT02848053.http://www.tmrjournal.com/EN/10.12032/TMR201812075Long-term effectDiabetesPreventionTianqi capsule
collection DOAJ
language English
format Article
sources DOAJ
author Bing Pang
Chun-Yong Han
Qing-Hu He
Jing Liu
Qing-Wei Li
Yu-Jiao Zheng
Feng-Mei Lian
Xiao-Lin Tong
spellingShingle Bing Pang
Chun-Yong Han
Qing-Hu He
Jing Liu
Qing-Wei Li
Yu-Jiao Zheng
Feng-Mei Lian
Xiao-Lin Tong
Long-term effect of Chinese herbal medicine Tianqi Capsule on the incidence of diabetes: an 8-year cohort study protocol
Traditional Medicine Research
Long-term effect
Diabetes
Prevention
Tianqi capsule
author_facet Bing Pang
Chun-Yong Han
Qing-Hu He
Jing Liu
Qing-Wei Li
Yu-Jiao Zheng
Feng-Mei Lian
Xiao-Lin Tong
author_sort Bing Pang
title Long-term effect of Chinese herbal medicine Tianqi Capsule on the incidence of diabetes: an 8-year cohort study protocol
title_short Long-term effect of Chinese herbal medicine Tianqi Capsule on the incidence of diabetes: an 8-year cohort study protocol
title_full Long-term effect of Chinese herbal medicine Tianqi Capsule on the incidence of diabetes: an 8-year cohort study protocol
title_fullStr Long-term effect of Chinese herbal medicine Tianqi Capsule on the incidence of diabetes: an 8-year cohort study protocol
title_full_unstemmed Long-term effect of Chinese herbal medicine Tianqi Capsule on the incidence of diabetes: an 8-year cohort study protocol
title_sort long-term effect of chinese herbal medicine tianqi capsule on the incidence of diabetes: an 8-year cohort study protocol
publisher Hong Kong Gold Orchid Science and Technology Co., Limited
series Traditional Medicine Research
issn 2413-3973
2413-3973
publishDate 2018-07-01
description Background: The rapid growth of type 2 diabetes mellitus (T2DM) remains a big challenge for clinicians worldwide. Traditional Chinese medicine may bring a new approach for solving this problem. The Tianqi Capsule Diabetes Prevention Study (REDUCES Study) reported that 1 years of therapy with Tianqi capsule reduced the risk of diabetes by 32.1% compared with the placebo. Here we aimed to assess the long-term effect of Tianqi capsule on prevention of T2DM in people with impaired glucose tolerance after discontinuation of active intervention. Methods/design: 420 subjects will be followed-up for 8 years to assess the long-term effect of Tianqi capsule intervention. The causes of death and the status of living subjects will be investigated. Follow-up data for living subjects will be collected by personal interview and clinical examination and medical record review to determine diabetes status. Questionnaires will be given to all the subjects to investigate the factors that probably affect the diabetes status during the 8-year of discontinuation of intervention. The primary outcome is the incidence of T2DM, and the secondary outcomes are body mass index, blood glucose, blood lipids and blood pressure. The Cox proportional hazards model will be used to estimate the hazard ratio for diabetes incidence. Analyses will be done with SAS 8.2 software package. Discussion: Results from this study may provide evidence for the long-term efficacy of Tianqi capsule in patients with prediabetes. The findings will provide a basis for further confirmatory studies. Ethics: The protocol has been approved by the Medical Ethics Committee of Guang’anmen Hospital of China Academy of Chinese Medical Sciences (approval number 2016-046-KY-01). Study registration number: ClinicalTrials.gov; NCT02848053.
topic Long-term effect
Diabetes
Prevention
Tianqi capsule
url http://www.tmrjournal.com/EN/10.12032/TMR201812075
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