scholarly journals Efficacy and Safety of a Chinese Herbal Formula (Invigorating Kidney and Strengthening Spleen) in Chronic Hepatitis B Virus Carrier: Results from a Multicenter, Randomized, Double-Blind, and Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-12 ◽  
Author(s):  
Jinsong He ◽  
Daqiao Zhou ◽  
Guangdong Tong ◽  
Yufeng Xing ◽  
Yingjie Chen ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Control Group ◽  
Herbal Formula ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Chinese Herbal Formula ◽  
Hbv Replication ◽  
Chinese Herbal ◽  
Chronic Hepatitis B Virus ◽  
Chronic Hbv

A Chinese Herbal Formula (CHF) has acquired a certain therapeutic effect on chronic HBV infection. To assess the efficacy and safety of CHF on HBV replication in chronic HBV carriers, we performed a randomized, double-blind, and placebo-controlled trial involving patients from 16 centers. A total of 300 confirmed chronic HBV carriers were randomized at baseline in a ratio of 2 : 1 to receive either CHF or placebo for 52 weeks. The results showed that a greater proportion of CHF than placebo treated patients achieved virological response at week 52; the mean decline of serum HBsAg levels in the CHF group dropped more obviously than that in the control group at all stages of the treatment; however, the rates of HBeAg loss and seroconversion had no difference between the two groups. Meanwhile, were presented significant increases in IFN-γ; IL-2 levels and reductions in IL-4 and IL-10 levels in the treatment group compared to the control group at week 52. There were no drug-related serious adverse events. In conclusion, the treatment with 52-week CHF is safe and effective in inhibiting HBV replication in chronic HBV carriers. The ability of the compound to modulate host immune function probably contributed to this effect.

scholarly journals Chinese Herbal Formula Xuefu Zhuyu for Stable Angina (CheruSA): Study Protocol for a Multicenter Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Shaojun Liao ◽  
Zhe Zhang ◽  
Geng Li ◽  
Li Zhou ◽  
Junwen Jiang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Heart Disease ◽  
Stable Angina ◽  
Controlled Trial ◽  
Routine Care ◽  
Control Group ◽  
Herbal Formula ◽  
Chinese Herbal Formula ◽  
Randomized Controlled ◽  
Chinese Herbal

Introduction. Stable angina (SA) in coronary heart disease is a common ischemic heart disease endangering the patient’s quality of life and longevity. Clinical trials have demonstrated that the Chinese herbal formula Xuefu Zhuyu (XFZY) has benefits for SA patients. However, there remains a lack of high-quality evidence to support clinical decision-making. Therefore, we designed a randomized controlled trial (RCT) to evaluate the efficacy and safety of XFZY for SA. Methods and Analysis. This multicenter, double-blinded RCT will be conducted in China. 152 eligible participants will be randomly assigned to either an XFZY group or a control group at a 1 : 1 ratio. Participants in the XFZY group will receive XFZY plus routine care, while those in the control group will receive placebo plus routine care. The study period is 26 weeks, including a 2-week run-in period, a 12-week treatment period, and a 12-week follow-up. The primary outcome is the change in visual analogue scale score for angina pain intensity from baseline to 12 weeks. The secondary outcomes are the angina attack frequency and duration, the nitroglycerin dosage consumed, the Canadian Cardiovascular Society grading of effort angina, the Seattle Angina Questionnaire, the EuroQol-5-Dimensions-5-Level, the incidence of major adverse cardiac events, health cost evaluation, and overall assessment for study drugs. Ethics and Dissemination. The study has been approved by the ethics committee of Guangdong Provincial Hospital of Chinese Medicine (approval no. BF2019-175-01). Results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences. This trial is registered with ChiCTR1900026899, registered on 26 October 2019.

scholarly journals The Efficacy and Safety of Traditional Chinese Medicine (Jiang Zhi Granule) for Nonalcoholic Fatty Liver: A Multicenter, Randomized, Placebo-Controlled Study

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Jielu Pan ◽  
Miao Wang ◽  
Haiyan Song ◽  
Lin Wang ◽  
Guang Ji
Keyword(s):  
Fatty Liver ◽  
Serum Triglyceride ◽  
Controlled Study ◽  
Herbal Formula ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Nonalcoholic Fatty Liver ◽  
Chinese Herbal Formula ◽  
Chinese Herbal

Objective. To evaluate the efficacy and safety of Jiang Zhi Granule (JZG), a Chinese herbal formula, in patients with nonalcoholic fatty liver (NAFL).Methods. A multicenter, randomized, double-blind, placebo-controlled, parallel clinical trial was conducted for 24 weeks in 224 patients with NAFL at 6 university-affiliated hospitals. Patients were randomized 1 : 1 to receive JZG and placebo, respectively. Primary outcome was the change of liver to spleen ratio (L/S ratio) over computed tomography (CT). Secondary outcomes included body mass index (BMI), serum triglyceride (TG), and total cholesterol (TC) levels.Results. Of all the 224 eligible patients, 221 patients were analyzed in the full analysis set (FAS), 205 in the per protocol set (PPS), and 3 patients were withdrawn prematurely. For FAS, JZG significantly increased L/S ratio from 0.74 ± 0.21 to 0.99 ± 0.24 compared to that from 0.79 ± 0.18 to 0.85 ± 0.27 in placebo group (P=0.0011). For PPS, it showed an increase of 0.26 ± 0.23 of L/S ratio in the patients on JZG versus 0.07 ± 0.22 in those on placebo (P=0.0003). Superiority of JZG over placebo was also observed with greater reduction in BMI (P<0.05) in both FAS and PPS. No observable difference in decrease of serum TC and TG was recorded (P>0.05). There were no serious adverse events (AEs) in the study process and safety indices were normal in both groups.Conclusions. The Chinese herbal formula JZG was found to be superior to placebo in increasing L/S ratio and reducing BMI in NAFL patients. It was also well tolerated in patients and might be a safe and effective medicine for NAFL.

scholarly journals Effects of the Chinese herbal formula San-Huang Gu-Ben Zhi-Ke treatment on Stable Chronic Obstructive Pulmonary disease:study protocol of a randomized, double-blind, placebo-controlled trial

2019 ◽  
Author(s):  
Yaqi Zu ◽  
Demin Li ◽  
Xiang Lei ◽  
Hongchun Zhang
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Herbal Formula ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Chinese Herbal Formula ◽  
Chinese Herbal ◽  
Copd Patients

Abstract Background: Due to the large number of patients, high mortality rate as well as high social costs and economic burden, Chronic obstructive pulmonary disease（COPD）has become one of the most important health problem around the world, which has attracted people's attention. Currently, Chinese herbs have been widely used as alternative medicine（CAM）for COPD patients. Chinese herbal formula San-Huang Gu-Ben Zhi-Ke（SHGBZK）have shown good clinical efficacy in COPD in preclinical studies. Animal experiments have enhanced that it has mucosal immune barrier function, it can maintain airway wall integrity, reduce inflammatory cell infiltration, promote inflammatory damage repair, and relieve airway narrow conditions. Methods/design: The study is a randomized, double-blind, placebo-controlled trial. A total of 100 COPD patients at stable stage that diagnosed with syndrome of deficiency of lung qi and spleen qi will be recruited and randomly assigned to one of the two treatments group, with 50 in each group. One hundred COPD patients were randomly assigned to two treatment groups（SHGBZK treatment, N=50; placebo treatment, N=50).The two groups will receive basic treatment for COPD according to the 2017 GOLD Guidelines for Chronic Obstructive Pulmonary Disease. Patients will stick to the treatment they used to take as much as possible, and will be given present general treatment when AECOPD occurs during the study. Both groups will receive an 24-weeks intervention, and patient status was assessed at 24 weeks later and 28 weeks after treatment. After the 24-weeks treatment, another 28 weeks will be followed up. The outcome measures including the frequency and duration of acute exacerbation, lung function, TCM symptom score, exercise capacity, and quality of life will be assessed. Discussion: It is hypothesized that SHGBZK will have beneficial effects in reducing the frequency and duration of acute exacerbation, improving exercise capacity function of COPD patients at stable stage that diagnosed with syndrome of deficiency of lung qi and spleen qi. This study may establish a new method for COPD patients, and thus differentiation from other drugs used for similar clinical indications in clinical use. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1800016349. Registered on 26 May 2018. Keywords: Chronic obstructive pulmonary disease; traditional Chinese medicine; Chinese herbal formula San-Huang Gu-Ben Zhi-Ke; clinical trials; clinical protocols.

scholarly journals Effects of the Chinese herbal formula San-Huang Gu-Ben Zhi-Ke treatment on Stable Chronic Obstructive Pulmonary disease:study protocol of a randomized, double-blind, placebo-controlled trial

2019 ◽  
Author(s):  
Yaqi Zu ◽  
Demin Li ◽  
Xiang Lei ◽  
Hongchun Zhang
Keyword(s):  
Controlled Trial ◽  
Chronic Obstructive ◽  
Herbal Formula ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Double Blind Placebo ◽  
Chinese Herbal Formula ◽  
Chinese Herbal ◽  
Copd Patients ◽  
Stable Stage

Abstract Background Due to the large number of patients, high mortality rate as well as high social costs and economic burden, Chronic obstructive pulmonary disease(COPD)has become one of the most important health problem around the world, which has attracted people's attention. Currently, Chinese herbs have been widely used as alternative medicine(CAM)for COPD patients. Chinese herbal formula San-Huang Gu-Ben Zhi-Ke(SHGBZK)have shown good clinical efficacy in COPD in preclinical studies. Animal experiments have enhanced that it has mucosal immune barrier function, it can maintain airway wall integrity, reduce inflammatory cell infiltration, promote inflammatory damage repair, and relieve airway narrow conditions. Methods/design The study is a randomized, double-blind, placebo-controlled trial. A total of 100 COPD patients at stable stage that diagnosed with syndrome of deficiency of lung qi and spleen qi will be recruited and randomly assigned to one of the two treatments group, with 50 in each group. One hundred COPD patients were randomly assigned to two treatment groups（SHGBZK treatment, N=50; placebo treatment, N=50).The two groups will receive basic treatment for COPD according to the 2017 GOLD Guidelines for Chronic Obstructive Pulmonary Disease. Patients will stick to the treatment they used to take as much as possible, and will be given present general treatment when AECOPD occurs during the study. Both groups will receive an 24-weeks intervention, and patient status was assessed at 24 weeks later and 28 weeks after treatment. After the 24-weeks treatment, another 28 weeks will be followed up. The outcome measures including the frequency and duration of acute exacerbation, lung function, TCM symptom score, exercise capacity, and quality of life will be assessed. Discussion It is hypothesized that SHGBZK will have beneficial effects in reducing the frequency and duration of acute exacerbation, improving exercise capacity function of COPD patients at stable stage that diagnosed with syndrome of deficiency of lung qi and spleen qi. This study may establish a new method for COPD patients, and thus differentiation from other drugs used for similar clinical indications in clinical use.

scholarly journals Chinese Herbal Formula Xuefu Zhuyu for Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern (CheruXTH): Study Protocol for a Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Li Zhou ◽  
Zhe Zhang ◽  
Geng Li ◽  
Shaojun Liao ◽  
Hongfei Zhou ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Blood Stasis ◽  
Tension Type Headache ◽  
Herbal Formula ◽  
Efficacy And Safety ◽  
Chinese Herbal Formula ◽  
Chinese Herbal ◽  
Qi Stagnation ◽  
Type Headache ◽  
Change In Mean

Background. Tension-type headache (TTH) is the most common headache disorder. Current treatments for TTH have been reported to be associated with insufficient long-term benefits and unwanted adverse events (AEs). The Chinese herbal formula Xuefu Zhuyu (XFZY) has been utilized in TTH treatment, but the evidence supporting its efficacy remains unclear. This study will evaluate the efficacy and safety of XFZY for TTH. Methods. This multicenter, double-blind, randomized, placebo-controlled trial will be undertaken in China. A total of 174 eligible participants will be randomly assigned to either an XFZY group or a placebo group (20 ml each dose, three times daily for 4 weeks) at a ratio of 1 : 1. The primary outcome is the change in mean headache intensity measured by a 10 cm visual analogue scale (VAS). Secondary outcomes include the area-under-the headache curve (AUC), headache frequency, rescue medication use, qi-stagnation and blood-stasis pattern measurement, quality of life measured by the EuroQol-5-Dimensions-5-Level (EQ-5D-5L), global evaluation of medication, and health economic indexes. Discussion. The results of the study are expected to provide evidence of high methodological and reporting quality on the efficacy and safety of XFZY for TTH. This trail is registered with ChiCTR1900026716 (registered on 19 October, 2019).

scholarly journals The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xiaohui Guo ◽  
Meiling Xuan ◽  
Huan Zheng ◽  
Shumin Qin ◽  
Haomeng Wu ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Life Questionnaire ◽  
Herbal Formula ◽  
Efficacy And Safety ◽  
Chinese Herbal Formula ◽  
Chinese Herbal ◽  
Irritable Bowel

Abstract Background Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common chronic digestive disease. Recent observational studies have reported that the Chinese herbal formula Huoxiang Zhengqi (HXZQ) can relieve IBS-D symptoms, but no high-level evidence is presented. Therefore, we want to evaluate the efficacy and safety of HXZQ for IBS-D patients. Methods This is a double-blind, randomized, placebo-controlled trial. The 212 eligible patients with IBS-D will be randomly assigned to receive either HXZQ oral liquid or a placebo, at a 1:1 ratio, for 4 weeks with a 4-week follow-up period. Adequate relief will be the primary outcome measures. IBS symptom severity score, IBS quality-of-life questionnaire, EQ-5D-5L, and Chinese medicine symptom questionnaire will be the secondary outcome measures. Discussion This trial aims to demonstrate the efficacy and safety of HXZQ for IBS-D, which is expected to be an effective IBS-D treatment. Trial registration The trial was registered with the Chinese Clinical Trial Registry, ChiCTR1900026837. Registered on 24 October 2019.

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