Efficacy and safety of herbal medicine (Binafuxi granules) for the common cold with fever: A multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial.

Background: Binafuxi granules are a traditional Uighur medicine (TUM) for treating the common cold with fever. However, high-quality clinical studies supporting its efficacy and safety are lacking. Methods: In this multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial, patients with common cold and fever were randomly assigned to a high-dose group, low-dose group, and placebo group in a 1:1:1 ratio. Outcomes were time to fever relief, time to fever clearance, proportion of afebrile patients, time to symptom disappearance, rate of symptom disappearance, effective rate, emergency drug usage and safety assessment. Results: A total of 235 patients were recruited. Of these, 234 were included in the full analysis set (FAS), and 217 were included in the per-protocol set (PPS). In the FAS analysis, the median time to fever relief was 6.00 h, 5.54 h and 10.65 h (P = 0.31) in the high-dose group, low-dose group and placebo group, respectively. The median time to fever clearance was 18.29 h, 20.08 h and 25.00 h (P = 0.0018), respectively, and the proportion of afebrile patients was 92.4%, 89.7% and 71.4% (P = 0.0002), respectively. There was a significant difference in the disappearance time and disappearance rate of all symptoms and of individual symptoms. No serious adverse events were found. Conclusions: Binafuxi granules can dose-dependently shorten the fever course and improve clinical symptoms in patients suffering from the common cold with fever. Trial Registration: This trial was registered at Chinese Clinical Trial Registry (ChiCTR-IIR-17013379).

Efficacy and safety of Tanreqing oral liquid in treatment of acute bronchitis: study protocol for a randomized controlled trial.

BACKGROUND: Approximately 5% of adults have an episode of acute bronchitis each year, accounting for more than 10 million medical visits yearly. The primary goal of treatment is reduction of symptoms. Currently, available medications are questionable in effectiveness and safety and are not recommended for routine use in clinical practice. Although Chinese herbal medicine has been widely used in the management of acute bronchitis in China, evidence-based data is lacking. This trial aims to evaluate the efficacy and safety of Tanreqing oral liquid in the treatment of acute bronchitis with phlegm-heat obstructing lungs syndrome. METHODS/DESIGN: This study is a prospective, multi-center, randomized, double-blinded, parallel-group, placebo-controlled trial. A total of 270 acute bronchitis adult patients with phlegm-heat obstructing lungs syndrome will be enrolled from outpatients and emergency departments at nine study centers across China. All included patients will be randomly allocated to receive Tanreqing oral liquid or placebo oral liquid, 20 mL three times daily for seven consecutive days. The primary outcome will be cough resolution rate. Secondary outcomes will include change of bronchitis symptoms scores from baseline to post-treatment, cough relief rate, time to cough resolution, time to cough relief, resolution rate of a single symptom, combination medicine use, change of traditional Chinese medicine syndrome score from baseline to post-treatment, and adverse events. DISCUSSION: This trial may provide an alternative treatment option for acute bronchitis patients, especially those in outpatients and emergency departments. It may also add evidence to Chinese herbal medicine for treating acute bronchitis. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000040264 . Registered on 26 November 2020.

Efficacy and safety of Zihua Wenfei granules in treatment of postinfectious cough (wind-cold invading lungs syndrome): study protocol for a randomized controlled trial.

BACKGROUND: Postinfectious cough usually develops and persists following respiratory tract infection. The protracted cough is embarrassing and troublesome and significantly impairs daily life. However, the optimal treatment available for this condition is still not known. This study aims to investigate the efficacy and safety of a new Chinese herbal prescription, Zihua Wenfei granule (ZHWFG), in treatment of postinfectious cough (wind-cold invading lungs syndrome). METHODS: This study is a prospective, multi-center, randomized, double-blinded, parallel group, placebo-controlled trial. A total of 216 adult participants with postinfectious cough will be enrolled from six study centers across China. All participants are randomly allocated to one of three parallel treatment groups: (1) 15 g of active ZHWFG three times daily, (2) 10 g of active ZHWFG plus 5 g of ZHWFG-matched placebo three times daily, and (3) 15 g of ZHWFG-matched placebo three times daily. The treatment duration is 14 consecutive days. The primary outcomes are cough resolution rate and cough relief rate. Secondary outcomes include time to cough resolution, time to cough relief, change from baseline in cough symptom score, cough visual analog scale value, traditional Chinese medicine syndrome score at days 7 and 14, and change of CQLQ from baseline to post-treatment as well as adverse events. DISCUSSION: This trial may not only investigate the efficacy and safety of ZHWFG in the management of postinfectious cough (wind-cold invading lungs syndrome), but also add the evidence of Chinese herbal medicine in treatment of postinfectious cough and provide an alternative option for the management of postinfectious cough. TRIAL REGISTRATION: ChiCTR1900022078. Registered on 23 March 2019. http://www.chictr.org.cn/showproj.aspx?proj=36547.

Binafuxi granules in the treatment of common cold with heat syndrome based on traditional Uighur medicine: study protocol for a multicenter randomized controlled trial.

BACKGROUND: The common cold is a highly prevalent illness with significant impact on society and health care. Common cold with heat syndrome (CCHS) is one of the most common types based on syndrome differentiation by traditional Uighur medicine (TUM), which is widely used in Central Asia. The study is designed to explore the efficacy, safety and optimal therapeutic dosage of Binafuxi granules in treating CCHS. METHODS: This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. Participants (n = 240) will be enrolled from five centers across China and randomly assigned to the high-dose group, low-dose group or placebo control group in a 1:1:1 ratio. All eligible patients will receive test drugs twice daily for 3 days. The primary outcome is the time to fever relief. Secondary outcomes include the time to fever clearance, duration of primary symptoms and each symptom and change in TUM symptom score. DISCUSSION: This is the first placebo-controlled randomized clinical trial of a Uighur medicine in treating common cold. It will provide robust evidence on the efficacy and safety of Binafuxi granules in the treatment of CCHS. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IIR-17013379 . Registered on 14 November 2017.

Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial.

BACKGROUND: The common cold is a common and frequent respiratory disease mainly caused by viral infection of the upper respiratory tract. Chinese herbal medicine has been increasingly prescribed to treat the common cold; however, there is a lack of evidence to support the wide utility of this regimen. This protocol describes an ongoing phase II randomized controlled clinical trial, based on the theory of traditional Chinese medicine (TCM), with the objective of evaluating the efficacy and safety of Lian-Ju-Gan-Mao capsules (LJGMC), a Chinese patent medicine, compared with placebo in patients suffering from the common cold with wind-heat syndrome (CCWHS). METHODS/DESIGN: This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial. A total of 240 patients will be recruited and randomly assigned to a high-dose group, medium-dose group, low-dose group, and placebo-matched group in a 1:1:1:1 ratio. The treatment course is 3 consecutive days, with a 5-day follow-up. The primary outcome is time to all symptoms' clearance. Secondary outcomes include time to the disappearance of primary symptoms and each secondary symptom, time to fever relief, time to fever clearance, and change in TCM symptom and sign scores. DISCUSSION: This trial is a well-designed study according to principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide high-quality evidence on the efficacy and safety of LJGMC in treating CCWHS and help to optimize the dose for the next phase III clinical trial. Moreover, the protocol presents a detailed and practical methodology for future clinical trials of drugs developed based on TCM. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IPR-15006504 . Registered on 4 June 2015.

The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial.

BACKGROUND: Common cold is one of the most frequently occurring illnesses in primary healthcare services and represents considerable disease burden. Common cold of Qi-deficiency syndrome (CCQDS) is an important but less addressed traditional Chinese medicine (TCM) pattern. We designed a protocol to explore the efficacy, safety, and optimal dose of Shen Guo Lao Nian Granule (SGLNG) for treating CCQDS. METHODS/DESIGN: This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. A total of 240 eligible patients will be recruited from five centers. Patients are randomly assigned to high-dose group, middle-dose group, low-dose group, or control group in a 1 : 1 : 1 : 1 ratio. All drugs are required to be taken 3 times daily for 5 days with a 5-day follow-up period. Primary outcomes are duration of all symptoms, total score reduction on Jackson's scale, and TCM symptoms scale. Secondary outcomes include every single TCM symptom duration and score reduction, TCM main symptoms disappearance rate, curative effects, and comparison between Jackson's scale and TCM symptom scale. ETHICS AND TRIAL REGISTRATION: This study protocol was approved by the Ethics Committee of Clinical Trials and Biomedicine of West China Hospital of Sichuan University (number IRB-2014-12) and registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-15006349).

Efficacy and safety of Qi-Wei-Qing-Yan aerosol in treatment of acute pharyngitis (lung-stomach excess-heat syndrome): study protocol for a randomized controlled trial.

BACKGROUND: Acute pharyngitis accounts for an estimated 15 million patient visits in the United States. However, there is no proven effective and safe treatment. Although Chinese herbal medicine is widely used in the treatment of acute pharyngitis, there is a lack of evidence-based data. Despite several clinical trials conducted in this setting, no randomized placebo-controlled trial has been performed to date. This trial aims to investigate the efficacy and safety of Qi-Wei-Qing-Yan aerosol (QWQYA), a Chinese herbal prescription, compared with a placebo aerosol in the treatment of acute pharyngitis with lung-stomach excess-heat syndrome. METHODS/DESIGN: This is a prospective, multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial. A total of 420 adult patients, of either sex, with acute pharyngitis will be enrolled from seven study sites across China. All patients will be randomly allocated to one of three parallel treatment groups: (1) QWQYA with the current propellant, (2) QWQYA with a previous propellant, and (3) the placebo aerosol with the current propellant. The study medication will be administered into the pharyngeal region in three sprays thrice daily for 5 consecutive days. The primary outcome measures are time to complete resolution of sore throat and relief rate of sore throat. Secondary outcome measures include resolution rate of sore throat, time to relief of sore throat, intensity of sore throat, and change of traditional Chinese medicine syndrome score and clinical signs score from baseline to post-treatment, as well as the occurrence of any adverse events. DISCUSSION: This will be the first clinical trial to investigate the efficacy and safety of QWQYA in the treatment of acute pharyngitis in an adult population in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it establish the basis for the efficacy and safety of QWQYA in treating acute pharyngitis, but it might also provide evidence to support the use of Chinese herbal medicine in treating acute pharyngitis and thus support an alternative treatment option for management of acute pharyngitis. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-IPR-15005991.

The efficacy of QingfengGanke granule in treating postinfectious cough in pathogenic wind invading lungs syndrome: a multicenter, randomized, double-blind, placebo-controlled trial.

BACKGROUND: Postinfectious cough (PIC) significantly affects cough-related quality of life but still lacks effective treatments. This study aims to investigate the efficacy of QingfengGanke granule (QFGKG) in treating PIC induced by pathogenic wind invading lungs syndrome. METHODS: A multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 180 eligible participants were randomly (1:1:1) assigned to group A (QFGKG 6 g plus QFGKG-matched placebo 6 g), group B (QFGKG 12 g), and group C (QFGKG-matched placebo 12 g). All herbal medications were orally administered twice daily for 10 consecutive days. The primary outcome was time to cough resolution, and secondary outcomes included time to cough alleviation, mean changes in cough symptom score (CSS), visual analogue scale (VAS) score, cough-specific quality of life questionnaire (CQLQ) score, and traditional Chinese medicine (TCM) syndrome score from baseline to Day 10, as well as adverse events. RESULTS: A total of 173 participants were included in the efficacy and safety analyses (group A, n = 57; group B, n = 57; group C, n = 59). The median time to cough resolution in groups A, B, and C was more than 10 days, 8 days, and more than 10 days, respectively (P < 0.0001), and the median time to cough alleviation was 4, 4, and 6 days, respectively (P < 0.0001). Compared with the placebo condition, groups A and B showed significantly greater improvements in CSS (P = 0.0005, P < 0.0001, respectively), VAS (P = 0.0002, P < 0.0001, respectively), CQLQ (P = 0.0258, P = 0.0003, respectively), and TCM syndrome (P = 0.0031, P < 0.0001, respectively). The time to cough resolution was faster in group B compared with group A (P = 0.0091). The adverse event profiles were comparable among the three groups. CONCLUSION: QingfengGanke granule is efficacious in the treatment of PIC induced by pathogenic wind invading lungs syndrome.

Efficacy and safety of Gantong Granules in the treatment of common cold with wind-heat syndrome: study protocol for a randomized controlled trial.

BACKGROUND: Although the common cold is generally mild and self-limiting, it is a leading cause of consultations with doctors and missed days from school and work. In light of its favorable effects of relieving symptoms and minimal side-effects, Traditional Chinese Medicine (TCM) has been widely used to treat the common cold. However, there is a lack of robust evidence to support the clinical utility of such a treatment. This study is designed to evaluate the efficacy and safety of Gantong Granules compared with placebo in patients with the common cold with wind-heat syndrome (CCWHS). METHODS/DESIGN: This is a multicenter, phase IIb, double-blind, placebo-controlled and randomized clinical trial. A total of 240 patients will be recruited, from 5 centers across China and randomly assigned to the high-dose group, medium-dose group, low-dose group or placebo control group in a 1:1:1:1 ratio. All subjects will receive the treatment for 3 to 5 days, followed by a 7-day follow-up period. The primary outcome is the duration of all symptoms. Secondary outcomes include the duration of primary symptoms and each symptom, time to fever relief and time to fever clearance, change in TCM symptom score, and change in Symptom and Sign Score. DISCUSSION: This trial will provide high-quality evidence on the efficacy and safety of Gantong Granules in treating CCWHS, and help to optimize the dose selection for a phase III clinical trial. TRIAL REGISTRATION: The registration number is ChiCTR-TRC-14004255 , which was assigned by the Chinese Clinical Trial Registry on 12 February 2014.

The efficacy and safety of Jian-Wei-Qu-Tong Pills for the treatment of chronic non-atrophic gastritis (spleen and stomach qi deficiency with damp-heat stasis syndrome): study protocol for a phase II, randomized controlled trial.

BACKGROUND: Chronic gastritis (CG), a poorly understood entity, is a very common disease of the digestive tract and is difficult to cure. Chronic non-atrophic gastritis (CNG) is the most common type of CG. Even if treated with current standard chemotherapy, some patients will not be freed from this confusing disease. Many studies have shown traditional Chinese medicine (TCM) is more effective compared to chemotherapy in the treatment of chronic gastritis and no serious side effects have been identified. However, the studies that have been carried out were not scientifically rigorous trials. Our aim is to design a high-quality trial for a new TCM drug, the Jian-Wei-Qu-Tong Pills (JWQTP), to investigate the efficacy and safety of this new drug in treating chronic non-atrophic gastritis patients with spleen and stomach qi deficiency with damp-heat stasis syndrome (SSQDDSS). METHODS/DESIGN: This is a phase II, multicenter, parallel-group, double-blind, randomized and placebo-controlled trial. A total of 240 participants will be assigned to a high-dose group, a low-dose group or a placebo control group with a 1:1:1 ratio at five sites. Then, one dose (six 1-g pills), with a variable ratio between real drug and dummy drug according to the intervention protocol, will be taken three times a day before each meal for 8 weeks. The primary outcome is the eradication rate of epigastric pain. The secondary outcome includes the changes of endoscopic examination, histopathological examination, traditional Chinese medicine symptom scores and patient-reported outcome instrument scores for chronic gastrointestinal diseases and the eradication rate of Helicobacter pylori (HP). DISCUSSION: Many CNG patients suffer from frequent, recurrent bouts of dyspeptic symptoms. This is the first clinical trial to evaluate the safety and efficacy of JWQTP in treating CNG with SSQDDSS in a multicenter, parallel-group, double-blind, randomized and placebo-controlled manner. This trial may not only provide evidence for a phase III clinical trial, but also a vision of an alternative option for CNG treatment. TRIAL REGISTRATION: The registration number, ChiCTR-TRC-14004088, was assigned by the Chinese Clinical Trial Registry on 7 January 2014.

Traditional Chinese medicine (Shun-Qi-Tong-Xie Granule) for irritable bowel syndrome: study protocol for a randomised controlled trial.

BACKGROUND: Irritable bowel syndrome (IBS) is a common gastrointestinal functional disorder with no effective therapy. Traditional Chinese medicine (TCM) is one of the most common complementary therapies in China. We designed this study to evaluate the efficacy and safety of Shun-Qi-Tong-Xie Granule (SQTX Granule), a TCM treatment, in patients with IBS with diarrhea (IBS-D). METHODS/DESIGN: A randomised, double-blinded, placebo-controlled, multi-centre, superiority clinical trial to evaluate the efficacy and safety of SQTX Granule is proposed. Eligible patients (Rome III) with IBD-S will be randomly assigned into SQTX Granule group and the placebo group. Patients will receive a 28-day treatment and a 2-month follow-up. The primary outcome measures include the scores of IBS-quality of life (IBS-QOL) rating scale and IBS-symptom severity scale (IBS-SSS) rating scale. The secondary outcome measures include the improvement of symptom scores, and the duration of abdominal pain and diarrhea. DISCUSSION: According to TCM theory, SQTX Granule has a regulating effect on abdominal pain, diarrhea and the syndrome of liver-spleen disharmony, which is similar to the symptoms of IBS-D. This study will provide objective evidence to evaluate the efficiency and safety of SQTX Granule in IBS-D treatment. TRIAL REGISTRATION: ChiCTR-TRC-14004241. Date of registration: 9 February 2014.

Treatment of common cold patients with the shi-cha capsule: a multicenter, double-blind, randomized, placebo-controlled, dose-escalation trial.

This study was designed to determine the therapeutic efficacy and safety of the Shi-cha capsule, a Chinese herbal formula, in the treatment of patients with wind-cold type common cold. In our multi-center, prospective, double-blind, randomized, placebo-controlled, dose-escalation trial, patients with wind-cold type common cold received 0.6 g of Shi-cha capsule plus 0.6 g placebo (group A), 1.2 g of Shi-cha capsule (group B), or 1.2 g placebo (group C), three times daily for 3 days and followed up to 10 days. The primary end point was all symptom duration. The secondary end points were main symptom duration, minor symptom duration, the changes in cumulative symptom score, main symptom score, and minor symptom score 4 days after the treatment, as well as adverse events. A total of 377 patients were recruited and 360 met the inclusive criteria; 120 patients constituted each treatment group. Compared with patients in group C, patients in groups A and B had significant improvement in the all symptom duration, main symptom duration, minor symptom duration, as well as change from baseline of cumulative symptom score, main symptom score, and minor symptom score at day 4. The symptom durations and scores showed slight superiority of group B over group A, although these differences were not statistically significant. There were no differences in adverse events. The Shi-cha capsule is efficacious and safe for the treatment of patients with wind-cold type common cold. Larger trials are required to fully assess the benefits and safety of this treatment for common cold.

Meta-analysis: traditional Chinese medicine for improving immune response in patients with unresectable hepatocellular carcinoma after transcatheter arterial chemoembolization.

OBJECTIVE: The aim of this study was to evaluate whether Traditional Chinese Medicine (TCM) improves immune response for unresectable hepatocellular carcinoma (UHCC) after transcatheter arterial chemoembolization (TACE) by using meta-analysis of data from the literature involving available randomized controlled trials of TCM in combination with TACE compared with that of TACE alone. METHODS: Literature retrieval was conducted through the Cochrane Library, MEDLINE, CENTRAL, Embase, CBMdisc, and CNKI, without language limitations. RESULTS: Based on our search criteria, we found 12 trials involving 1,008 patients. Our results showed that the differences of pooled weighted mean difference before and after treatment and 95% confidence intervals (CIs) were 13.63 (8.96-18.69; P = .0001) for the proportion of CD3(+) T cells, 10.56 (6.91-14.21; P = .0001) for the proportion of CD4(+) T cells, -3.40 (-6.83 to 0.03; P = .052) for the proportion of CD8(+) T cells, 0.54 (0.42-0.66; P = .0001) for the ratio of CD4(+)/CD8(+), and 12.34 (7.26-17.41; P = .0001) for the proportion of natural killer cells. No serious adverse events were reported. CONCLUSIONS: Traditional Chinese Medicine in combination with TACE improves the immune response of patients with UHCC. However, considering the strength of the evidence, additional randomized controlled trials are needed before TCM plus TACE can be recommended routinely.

[Aidi Injection as an adjunct therapy for non-small cell lung cancer: a systematic review].

OBJECTIVE: To assess methodological quality of clinical studies using Aidi Injection as an adjunct therapy for non-small cell lung cancer (NSCLC) and to evaluate the effects of Aidi Injection. METHODS: PubMed (1980-2008), Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2008), EMBASE (1984-2008), CancerLit (1996-2003), CBMdisc (1980-2008), CNKI database (1980-2008), Wanfang database (1980-2008), and Chongqing VIP database (1980-2008) were searched. The authors also hand-searched Chinese periodicals potentially related to the question. All randomized controlled trials comparing Aidi Injection with other treatment methods of NSCLC were included. Two reviewers selected studies, assessed the quality of studies, and extracted the data independently. The included studies were appraised and analyzed by Cochrane Collaboration Review Manager 5.0. RESULTS: Fourteen randomized controlled trials were included in the meta-analysis, but the quality of reports of the 14 included studies was poor. Aidi Injection combined with cobalt-60 or navelbine and platinol (NP) showed statistically significant differences in improving the response rate as compared with single use of cobalt-60 (P=0.000 2) or NP (P=0.04), and the relative risk (RR) and 95% confidence interval (CI) were 1.93 [1.36, 2.72] and 1.18 [1.00, 1.38], respectively. However, Aidi Injection combined with etoposide and platinol (EP), taxinol and platinol (TP) or gamma knife showed no significant differences as compared with single use of EP (P=0.60), TP (P=0.16) or gamma knife (P=0.34), respectively. The RR and 95% CI of EP, TP and gamma knife were 1.17 [0.65, 2.09], 1.27 [0.91, 1.78] and 1.08 [0.92, 1.26] respectively. Six studies indicated that Aidi Injection combined with NP or gamma knife could improve the quality of life.Six studies showed that Aidi Injection combined with NP or TP could improve the bone marrow hematopoietic function.Three studies indicated that Aidi Injection combined with NP could improve the immune function. Three studies showed that the combined therapy could not improve 1-, 2-, and 3-year survival rates. CONCLUSION: The results of meta-analysis indicate that Aidi Injection may have adjuvant therapeutic effects in treatment of NSCLC patients, but the sample size is too small and with poor quality, and the existence of publication bias is found.The effects of Aidi Injection need to be confirmed by large multicenter randomized controlled trials.