Intervention strategy of Traditional Chinese Medicine for prediabetes(the syndrome of spleen-deficiency phlegm-dampness ) based on the reversal of blood glucose and the improvement of fatigue

Abstract Background:Prediabetes is a growing health concern,a large percentage of whom will develop full 2 type diabetes. The prominent symptom of patients with diabetes and prediabete is fatigue.The syndrome of spleen-deficiency phlegm-dampbess is the main syndrome of prediabetes.Effective intercentions on prediabetes will delay or prevent the occurrence or development of diabetes. Methods:Randomized controlled trial is implemented in this study.The study term is 3 months.Participants are recruited from Binhai hospital of Tianjin of Traditional Chinese Medicine,Jinghai hospital of Tianjin of Traditional Chinese Medicine and affiliated Wuqing hospital of Tianjin university of Traditional Chinese Medicine.160 participants are randomized to treatment group(Liu Jun Zi granules) and control group(Liu Jun Zi granules emulsifier):80 participants each.Participants being included in this study must have been diagnosed as prediabetes via western medicine criteria and traditional Chinese Medicine criteria.The primary outcomes is the score of fatigue-scale 14 and the rate of blood glucose return to the normal.The secondary outcomes inludes fasting plasma glucose,2-hour post-meal blood glucose and blood lipid test.The indexes of safety include general medical examination;electrocardiogram(ECG),liver function(ALT) and renel function(BUN,Creatinine) test and record of adverse event. Discussion:The aim of this study is to evaluate the effectiveness and safety of Liu Jun Zi granules for the treatment of patients with prediabetes. Trial registration:Chinese clinical trials register ChiCTR1900022736.

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Efficacy of Integrated Rehabilitation Techniques of Traditional Chinese Medicine for Ischemic Stroke: A Randomized Controlled Trial

The American Journal of Chinese Medicine ◽

10.1142/s0192415x13500651 ◽

2013 ◽

Vol 41 (05) ◽

pp. 971-981 ◽

Cited By ~ 16

Author(s):

Yong Zhang ◽

He Jin ◽

Dayong Ma ◽

Yuanbo Fu ◽

Yanming Xie ◽

...

Keyword(s):

Ischemic Stroke ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Controlled Trial ◽

Alternative Therapy ◽

Intervention Group ◽

Lower Limbs ◽

Control Group ◽

Significant Difference ◽

Long Term Observation

This study aimed to determine the efficacy of Integrated Rehabilitation Techniques of Traditional Chinese Medicine (IRT-TCM) on patients with ischemic stroke as an alternative therapy to conventional rehabilitation techniques. Sixty-nine patients with ischemic stroke were randomly assigned to receive either IRT-TCM (intervention group, n = 46) or conventional rehabilitation techniques (control group, n = 23). The IRT-TCM consisted of a sequential combination of acupuncture and massage techniques. The Fugl-Meyer Assessment (FMA), National Institutes of Health Stroke Scale (NIHSS), Barthel index (BI) and modified Rankin Scale (mRS) were measured on day 0 (baseline, before treatment), day 21, and day 90. We observed that the scores in FMA and BI were increased, and NIHSS were decreased in both groups on day 21 and 90, compared with the baseline (day 0). Furthermore, significantly better scores in FMA of lower limbs and NIHSS were found in patients treated with IRT-TCM on day 21 and 90. For mRS, the percentage of patients ranking 0 and 1 in the intervention group presented a striking contrast to the control group on day 90 but with no significant difference. The results indicated that, as a feasible alternative therapy, IRT-TCM is beneficial for patients with ischemic stroke. Further research with larger sample size, long-term observation, and strict blinding are still in need to confirm the efficacy of IRT-TCM.

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Clinical Evidence-Based Evaluation of ZFXNY in Treatment of Acute Cerebral Infarction

10.21203/rs.3.rs-689587/v1 ◽

2021 ◽

Author(s):

Wei Hu ◽

Chenhui Zhang ◽

Hong Zhang

Keyword(s):

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Cerebral Infarction ◽

Controlled Trial ◽

Case Fatality ◽

Test Group ◽

Acute Cerebral Infarction ◽

Control Group ◽

Chronic Obstructive ◽

Evidence Based

Abstract Background: Stroke is a severe and life-threatening disease, owns high rates of disability and mortality.[1] Stroke and ischemic heart disease, chronic obstructive pulmonary disease are the world’s three main killers.Ischemic strokes account for the vast majority of strokes.[2] Modern medicine has some advantages in treating ischemic stroke, but there are also limitations. Traditional Chinese medicine has thousands of years of experience in treating stroke, but there are few high quality clinical Randomized controlled trial.Methods: This is a multicenter, randomized, double-blind, placebo-controlled trial. 286 patients were randomly divided into test group and Control Group. Both groups received General Western medicine treatment, the test group combined with Chinese medicine treatment, the control group combined with placebo treatment. The duration of treatment was 30 days and the follow-up was 90 days. evaluation indicators include: Modified Rankin Scale, NIH stroke Scale, Glasgow Coma Scale, Barthel Index, Case fatality rate.Laboratory specifications and safety assessments will also be taken into account.Discussion: The aim of this study was to evaluate the safety and efficacy of ZFXNY in the treatment of acute cerebral infarction. Our research will provide a reliable evidence-based medicine basis for the treatment of acute cerebral infarction with traditional Chinese medicine, and provide another option for the treatment of acute cerebral infarction.Trial registration: ChiCTR2100043796, Registered February 28th, 2021.

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Correlation Analysis of Huayu Tongmai Decoction Intervention and Prognosis Indexes of Patients with Carotid Atherosclerosis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/2739092 ◽

2021 ◽

Vol 2021 ◽

pp. 1-7

Author(s):

Guangqing Cheng ◽

Xiaoni Yan ◽

Fengmeng Wang ◽

Chao Chen

Keyword(s):

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Carotid Atherosclerosis ◽

Blood Lipid ◽

Control Group ◽

Common Disease ◽

Observation Group ◽

Plaque Volume ◽

Female Ratio ◽

Hs Crp

Background. Carotid atherosclerosis (CAS) is a common disease which seriously threatens the health of senile patients. The studies have indicated that traditional Chinese medicine (TCM) may effectively improve the symptom of CAS, while the therapeutic effect of Huayu Tongmai decoction on CAS remains unclear. Thus, this study aimed to explore the correlation between traditional Chinese medicine Huayu Tongmai decoction intervention and prognosis indexes of patients with CAS. Methods. Ninety CAS patients admitted to Zibo TCM-Integrated Hospital from September 2018 to September 2020 were selected as the research object and randomly divided into the control group and the observation group according to the male-female ratio of 1 : 1. Patients in the control group accepted the atorvastatin intervention, and on this basis, patients in the observation group were further intervened with TCM Huayu Tongmai decoction. Before and after treatment, patients’ levels of total cholesterol (TC), triglyceride (TG), and low-density lipoprotein cholesterol (LDL-C) were measured by the enzyme photometric colorimetry; hypersensitive c-reactive protein (hs-CRP) levels were measured by the ELISA method; nitric oxide (NO) levels were measured by the nitrate reductase assay and endothelin-1 (ET-1) levels were measured by radioimmunoassay; and the right and left carotid internal diameter (CAD), intima-media thickness (IMT), and plaque volume were measured by carotid ultrasonography. Results. The TC, TG, and LDL-C levels significantly decreased in patients compared to those before intervention; compared with the control group, patients who accepted Huayu Tongmai decoction combined with atorvastatin saw more significant improvement in their blood lipid indexes ( P < 0.01 ); after intervention, patients’ hs-CRP and ET-1 levels dropped significantly while the NO level rose remarkably, and between the two groups, the improvement in levels of hs-CRP, ET-1, and NO of patients in the observation group was significantly better ( P < 0.01 ); it was concluded from the imaging diagnosis results that compared with using atorvastatin alone, the combined intervention could better improve patients’ CAD, IMT, and plaque volume. Conclusion. Huayu Tongmai decoction can effectively improve patients’ blood lipid, reduce inflammatory response, enhance levels of relevant regulatory factors of CAS, and alleviate the symptoms.

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Efficacy and Safety of Xiaoyao Pills for Mild to Moderate Depression With Syndrome of Liver Stagnation and Spleen Deficiency: Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-449004/v1 ◽

2021 ◽

Author(s):

Zhe Xue ◽

Zhen Huang ◽

Shu-li Cheng ◽

Xi-hong Wang ◽

Xuan Zhou ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Adverse Reactions ◽

Controlled Trial ◽

Secondary Outcome ◽

Efficacy And Safety ◽

Spleen Deficiency ◽

Randomized Controlled ◽

Moderate Depression

Abstract Background: Depression is one of the most frequent and severe psychiatric conditions. Many chemical drugs to treat depression are associated with adverse reactions and have shortcomings. Traditional Chinese medicine is of great significance in the prevention and treatment of depression. Xiaoyao pills has achieved good results in clinical application, which has the advantages of quick effect and no obvious adverse reactions. The aim of our study is to evaluate the efficacy and safety of Xiaoyao pills on mild to moderate depression patients with syndrome of liver stagnation and spleen deficiency.Methods: This study is a multi-center, double-blinded, randomized and placebo-controlled clinical trial. A total of 108 participants will be assigned to three groups: Xiaoyao pill group taking Xiaoyao pills twice daily for 4 weeks, placebo group taking placebos twice daily for 4 weeks and normal group without taking any drug. The primary and secondary outcome measures are the Hamilton Depression Scale (HAMD) and Traditional Chinese Medicine (TCM) Syndrome Scale. The assessment is at baseline(before treatment initiation), 1 week, 2 weeks 4 weeks after the first treatment. Exploratory outcome is also assessed to explore the mechanism of Xiaoyao pills at baseline and 4 weeks.Discussion: The results from this study will provide clinical evidence on the efficacy and safety of Xiaoyao pills in patients with mild to moderate depression with syndrome of liver stagnation and spleen deficiency.Trial registration: International Standard Randomized Controlled Trial Number Register: ISRCTN12746343. Registered on September 25, 2020.

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Baidu Jieduan granule, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

10.21203/rs.3.rs-44542/v2 ◽

2020 ◽

Author(s):

Wen Zhang ◽

Qin Xie ◽

Xiaoming Xu ◽

Shuting Sun ◽

Tian Fan ◽

...

Keyword(s):

Clinical Trial ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Controlled Trial ◽

Theory And Practice ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Open Label ◽

Randomized Controlled

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granule in treatment of moderate COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

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A meta-analysis of neuroprotective effect for traditional Chinese medicine (TCM) in the treatment of glaucoma

Open Medicine ◽

10.1515/med-2016-0006 ◽

2016 ◽

Vol 11 (1) ◽

pp. 25-30 ◽

Cited By ~ 2

Author(s):

Li Chao ◽

Lu Na ◽

Li Bin ◽

Zheng Botao ◽

Li Shuaijie

Keyword(s):

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Western Medicine ◽

Recovery Rate ◽

Neuroprotective Effect ◽

Controlled Trial ◽

Meta Analysis ◽

Control Group ◽

Cochrane Central Register ◽

Standard Mean Difference

AbstractBackgroundThe aim of this study was to evaluate the neuroprotective effect of surgery combined with traditional Chinese medicine(TCM)in the treatment of glaucoma by meta-analysis based on clinical controlled trial.MethodsAll the prospective randomized controlled trialsof surgery combined with TCM in the treatment of glaucoma were searched in the databases of Medline (1960-2015.1), CENTRAL (the Cochrane central register of controlled trials 1989-2015.1, EMBASE (1980∼2015.1) and CNKI (1979-2015.1). Two reviewers independently assessed the quality of the included studies, extracted the relevant data and performed a cross-check. The pooled relative risk (RR) or standard mean difference (SMD) of surgery combined with TCM versus western medicine or surgery alone were calculated as the effect size by meta-analysis method. All the data was analyzed by stata11.0 software (http://www.stata.com; Stata Corporation, College Station, TX).ResultsFinally, eleven clinical controlledtrails with 843 subjects were included in this meta-analysis. The pooled results indicated that the surgery combined with TCM treatment procedure can significant improve the vision recovery rate compared to control group (RR=1.22, 95% CI:1.06∼1.40, P=0.005); And after treatment, the visual field in combined group was significantly improved compared to control group (SMD=0.26∼95% CI:0.09∼0.43, P=0.003).ConclusionSurgery combined with TCM can improve the vision recovery rate and the visual fieldin the treatment of glaucoma compared to surgery or western medicine alone.

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Baidu Jieduan granules, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label, randomized controlled clinical trial

Trials ◽

10.1186/s13063-021-05418-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Wen Zhang ◽

Qin Xie ◽

Xiaoming Xu ◽

Shuting Sun ◽

Tian Fan ◽

...

Keyword(s):

Clinical Trial ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Controlled Trial ◽

Theory And Practice ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Open Label ◽

Randomized Controlled

Abstract Background Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive effects on human health. Due to the absence of antiviral medicine for COVID-19 thus far, there is a desperate need to develop effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, with the aim of achieving clinical efficacy and decreasing the use of antibiotics and glucocorticoids. The aim of this study was to evaluate the efficacy and safety of Baidu Jieduan granules in treating COVID-19. Methods/design This multicentre, open-label, randomized controlled trial will be conducted in 300 patients with COVID-19. The patients will be randomly (1:1) divided into a treatment group and a control group. All patients will receive standard therapy at the same time. Patients in the experimental group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes will be assessed at baseline and at 3, 5, 7 and 14 days after treatment initiation. The primary outcome will be the rate of symptom (fever, fatigue and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial. Discussion The study will provide high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granules in the treatment of moderate COVID-19, and enrich the theory and practice of TCM in treating COVID-19. Trial registration Chinese Clinical Trial Registry ChiCTR2000029869. Registered on 15 February 2020

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Clinical Study on Treatment of Vascular Aging in Patients with Type 2 Diabetes Complicated by Hypertension with Combination of Traditional Chinese Medicine and Western Medicine

Proceedings of Anticancer Research ◽

10.26689/par.v3i4.1050 ◽

2019 ◽

Vol 3 (4) ◽

Author(s):

Bin Ju

Keyword(s):

Blood Pressure ◽

Type 2 Diabetes ◽

Blood Glucose ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Western Medicine ◽

Blood Lipids ◽

Control Group ◽

Observational Group

Objective: To explore the clinical effect of combination of traditional Chinese medicine and western medicine in treatment of vascular aging in patients with type 2 diabetes complicated by hypertension. Methods: Ninety patients with type 2 diabetes complicated by hypertension admitted to our hospital from May 2016 to August 2019 were selected as research objects. They were randomly divided into control group and observational group, with 45 cases each. Control group was given amlodipine besylate combined with metformin hydrochloride. On the basis of control group, observational group was given combination of TCM syndrome differentiation. Blood glucose, blood pressure and blood lipids before and after 14 days of treatment were compared between two groups. Results: Blood glucose, blood pressure and lipid indexes after treatment were lower than before treatment in both groups; observational group was lower than control group and the difference was statistically significant (P<0.05). Conclusion: Combination of traditional Chinese medicine and Western medicine could lower blood glucose and blood pressure indexes, control blood lipids and delay blood vessel aging in patients with type 2 diabetes complicated by hypertension, it is worthy of clinical popularization.

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Acupuncture to Boost Breast Milk in Postpartum Hypogalactia: Randomized Controlled Trial

Journal of the Medical Association of Thailand ◽

10.35755/jmedassocthai.2021.12.13045 ◽

2021 ◽

Vol 104 (12) ◽

pp. 1930-1936

Keyword(s):

Chinese Medicine ◽

Treatment Group ◽

Breast Milk ◽

Traditional Chinese Medicine ◽

Conventional Treatment ◽

Controlled Trial ◽

Control Group ◽

Breast Milk Production ◽

Early Postpartum ◽

Breastfeeding Rate

Background: Breast milk is appropriate and useful but the exclusive breastfeeding rate in Thailand was quite low at only 23.1%. Hypogalactia is one of the important barriers of breastfeeding. Studies in Asia and the west have shown that acupuncture could boost breast milk. However, some articles had controversial result. There has been no study to assess efficiency of acupuncture in early postpartum hypogalactia. Objective: To compare the efficacy of acupuncture and conventional treatment for stimulating breast milk in early postpartum hypogalactia at 48 hours. Materials and Methods: A randomized, prospective, clinical trial was used for the present study. Sixty postpartum hypogalactic women of term gestation in postpartum ward in Charoenkrung Pracharak Hospital between March 1, 2020 and February 28, 2021 were enrolled. They were randomized into acupuncture and control groups. In the study group, mothers received once a day acupuncture at 13 acupoints without electrode for three consecutive days by qualified Traditional Chinese Medicine practitioner other than conventional treatment. Breast milk quantity were measured at day 1, day 7, and day 14 after the intervention. Results: Mean age of all participants was 29.72±5.96 year, mostly primigravida, delivered by vaginal route. Mean milk volume in the treatment group were significantly higher than the control group (p<0.05) with day 1 at 19.00±22.25 versus 5.97±6.08 mL, day 7 at 78.10±60.38 versus 40.17±28.82 mL, and day 14 at 128.33±64.86 versus 75.00±57.96 mL. The amount of breast milk in the treatment group were 3-fold, 2-fold, and 1.7-fold times more than the control group at day 1, day 7, and day 14, in respective order (p<0.05). Conclusion: Accurate acupuncture intervention could boost breast milk production in early postpartum hypogalactia at 48 hours. Keywords: Postpartum hypogalactia; Acupuncture; Traditional Chinese Medicine (TCM)

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Shengmai Yin formula modulates the gut microbiota of spleen-deficiency rats

Chinese Medicine ◽

10.1186/s13020-020-00394-y ◽

2020 ◽

Vol 15 (1) ◽

Author(s):

Yu You ◽

Lin Luo ◽

Yanyan You ◽

Yanjun Lin ◽

Huiling Hu ◽

...

Keyword(s):

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Gut Microbiota ◽

Vasoactive Intestinal Peptide ◽

Body Mass ◽

Relative Abundance ◽

The Body ◽

Control Group ◽

Spleen Deficiency ◽

Model Control

Abstract Background Spleen-deficiency syndrome, an important pathological change in traditional Chinese medicine, has been proven to attribute to intestinal dysbacteriosis. Shengmai Yin (SMY), a classic formula for replenishing qi and restoring pulse, is a common medicine for critical emergencies in traditional Chinese Medicine. Interestingly, our previous study established a spleen-deficiency rat model and verified the potency of SMY formula in curing spleen-deficiency rats. Our goal herein was to explore whether SMY can modulate the composition of intestinal flora and alleviate spleen-deficiency in rats. Methods This experiment was randomly divided into three groups, namely the normal control group (NC), model control group (MC), and the Shengmai Yin group (SMY). After the treatment, the weight and symptom indexes of the rats were recorded, histological changes in the colon were observed, levels of serum D-xylose, gastrin (GAS), and vasoactive intestinal peptide (VIP) were measured, and gut microbiota profiling was conducted by 16S rRNA sequencing. Results The body mass of the spleen-deficiency model rats significantly decreased compared with that of the NC group, and SMY treatment significantly increased body mass compared with the MC group (P < 0.01). Colon histopathology revealed that SMY treatment alleviated colonic mucosal damage in spleen-deficiency rats. The serum levels of D-xylose and gastrin (GAS) were significant increased by SMY (P < 0.05, P < 0.01), and vasoactive intestinal peptide (VIP) was reduced by SMY (P < 0.01) compared with MC. Furthermore, alpha diversity was significantly decreased in the model rats compared to the normal rats (P < 0.05) and increased with SMY treatment (P < 0.01). The most abundant phyla were Firmicutes and Bacteroidetes, followed by Proteobacteria, Verrucomicrobia, and Actinobacteria. At the genus level, there was a lower relative abundance of Lactobacillus, Bacteroides, Akkermasia, and Allobaculum, and a higher relative abundance of Lachnospiraceae NK4A 136 group, Ruminococcaceae UCG-014, and Sphingomonas in the MC group. The relative abundance of Actinobacteria, Alistipes, Bifidobacterium, Bifidobacterium, Bifidobacteriaceae, Lachnospiraceae NK4A136group, Lactobacillus, Lactobacillaceae, Bacilli, Verrucomicrobiae, and Akkermansia were significantly abundant in the treatment groups, and thus may be singled out as potential biomarkers for SMY in the treatment of spleen deficiency. In addition, analysis on the correlation between species and physicochemical indexes showed that the abundance of Parasutterella was negatively correlated with the change in GAS, and positively correlated with the change in VIP (P < 0.01). Conclusion Our findings have provided preliminary evidence that modulating the gut microbiota may play a role in the treatment of spleen deficiency with SMY. However, further studies are needed to clarify the mechanism by which SMY regulation of related gut microbiota occurs.

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