Registration of intervention trials of Traditional Chinese Medicine for four neurological diseases on Chinese Clinical Trial Registry and Clinical Trials.gov:a narrative review

OBJECTIVE:To analyze the current status of clinical trial registration of Traditional Chinese Medicine(TCM)for the treatment of neurological diseases.METHODS:Interventional clinical trials of TCM treatment for ischemic stroke,hemorrhagic stroke,vascular cognitive impairment,tension-type headache before September 22,2020 on the platform of Chinese Clinical Trial Registry(Chi CTR),and Clinical Trials.gov were searched.Two researchers independently selected the literature and extracted data.RESULTS:A total of 180 interventional clinical trials were included for analysis.Out of 180 trials,127 were from Chi CTR and 53 from Clinical Trials.gov.The countries primary sponsoring the included trials were China(176,97.8%),and the common categories of primary sponsors were hospital(131,72.8%).Among the study design,the largest proportion of allocation was randomized(172,95.6%),interventional model assignment was parallel(163,90.6%),masking was double blind 49(27.2%),and the sample size was≤400(144,80.0%).The trials were most carried out at a single center(102,56.7%).Among the included studies,112(62.2%)registered on Chi CTR attached the ethical approval documents.In terms of trial stages,50(27.7%)studies were in phaseⅣ.The mostly used intervention was Chinese herbal medicines(99,55%),acupuncture(68,37.8%)was the second.By searching the registration number on China National Knowledge Infrastructure Database and Pub Med,38(21.1%)registered trials were published,including 25 protocol studies and 14 research results with one(NCT02275949)published both the protocol and the results.CONCLUSIONS:Irregular and inadequate reporting,untimely update and publication,insufficient information on traditional medicine unique characteristics,and lack of international collaborations are the problems existing in the interventional clinical registration trials of traditional medicine treatment on neurological diseases.More efforts need to be made from the above aspects to standardize and improve the registration of traditional medicine trials.

International Clinical Trials Registry Platform(ICTRP)

Introduction The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base. The registration of all interventional trials is a scientific, ethical and moral responsibility.

International Comparison of Data from International Clinical Trials Registry Platform-Registered Clinical Trials

Objectives: Our aim was to clarify the study characteristics of countries that have registered clinical trials studies and to calculate the percentage of clinical trials that were registered in each country’s registry, and try to find and evaluate the factors determining that percentage. Design and Methods: The present study is a cross-sectional study using data from clinical trials registered from January 1, 2011, to December 31, 2015. Only countries with more than 2000 registered trials were included for further study. Ten countries met that criterion: United States, Japan, Iran, Australia, New Zealand, China, India, Germany, United Kingdom, and Netherland. The percentage of clinical trials that were registered in each country’s registry was calculated, and the factors determining that percentage were sought and analyzed through an exploratory approach. Results: The chi-squared test of independence indicated that the rate of clinical trial registration significantly differed between countries. From the adjusted standardized residuals, the percentage of clinical trials that were registered in the country of origin was higher in the United States, India, Japan, and Australia/New Zealand than in the European Union and China. Conclusion: The United States requires that informed consent documents for clinical trials contain clinical trial registration numbers from ClinicalTrials.gov, which could be the reason for the extremely high percentage of registered clinical trials (94%). Since the European Union does not have this requirement, clinical trials conducted in the European Union do not have to be registered in the countries in which they are conducted.

The progression of clinical trials in Indonesia:an observational study of records from clinical trial registries databases

Objective:This report presents an overview on the progress of clinical trials in Indonesia based on database assessment from clinical trial registries.Methods:Study records that were registered up to December 26,2018,were extracted from three clinical trial registries(ClinicalTrials.gov,ISRCTN registry,and EudraCT)and a clinical trial register(WHO International Clinical Trials Registry Platform(ICTRP))with the keyword“Indonesia”.A total of 505 records comprised of 402 interventional studies and 103 observational studies were found and analyzed.Results:The top five noncommunicable diseases(NCDs)studied were cancers,diabetes,cardiac diseases,hypertension,and gastrointestinal diseases,while the top five infectious diseases(IDs)were malaria,tuberculosis,vaccines for IDs,HIV,and dengue.Remarkably,the proportion of regional studies(within Indonesia only)was higher than that of multiregional studies(including areas outside of Indonesia)in general.This trend became most apparent after the issuance of national regulations on Material Transfer Agreements(MTA)and other rules.Upon closer scrutiny,regional clinical trials and multiregional clinical trials(MRCTs)in Indonesia differed in terms of sponsorship,target population and size,interventions,and study phases.Conclusions:The total number of clinical trials in Indonesia is increasing and is mainly attributed to the growing number of regional clinical trials sponsored from within the country.Interrelated factors have shaped the characteristics of these as compared to the dwindling number of MRCTs.Establishment of a national level of management is an option that can better facilitate both MRCTs as well as regional clinical trials,to better address the national health issues,and to cope with the regulations.

Open label,interventional,single arm multicentric clinical study to analyze the potency of VELNEZ nasal pack,post-nasal surgery

Background:Nasal packs are central to nasal surgeries.Primarily,these packs function by controlling bleeding,modulating pain and reducing adhesions post-surgery.However,the major setback of the currently used conventional nasal packs is the unbearable pain the patient undergoes upon removal of these packs.To overcome this shortcoming a variety of biodegradable packs have emerged.This study was aimed at evaluating the safety,efficacy and tolerability of VELNEZ nasal packs.VELNEZ,a patented Datt Mediproducts Pvt.Ltd.nasal pack,is one of its kind biodegradable composite that fragments within a few days of application.Methods:Eighty patients were included in an open label,interventional,single arm clinical study using clinical endpoints to investigate the safety and efficacy of nasal pack VELNEZ.The patients were questioned using a visual analog scale from discharge day to 28th postoperative day(9 follow-up visits)at regular intervals.The standardized questionnaires for hemorrhage control,relief from postoperative pain,moderate obstruction,and pain were used.Results:A total of 76 patients were enrolled in the study and 74 patients completed the study.VELNEZ nasal pack played a significant role in controlling hemorrhage and reducing postoperative pain.The average hemorrhage control time was 7.49±3.90 min with only 34.24%of population complaining of pain on the sixth day of surgery(follow-up 4).Forteen days postsurgery only 10.95%of subject population complained of postoperative pain.This biodegradable composite has an average fragmentation time of 4.7 days in the nasal cavity.In addition,this study did not observe any postoperative adverse events or serious adverse events.Conclusion:VELNEZ,a fragmentable nasal pack,is comfortable,safe,and effective against postsurgery bleeding and pain.

Research progress in rehabilitation treatment of stroke patients A bibliometric analysis

BACKGROUND： Stroke presents as a transient or chronic brain dysfunction and is associated with high morbidity and high mortality. The doctors and scientists would like to argue how to enhance the validity of the rehabilitation treatment and how to further improve the level of treatment on stroke. OBJECTIVE： The aim of this study was to quantitatively analyze the current worldwide progress in research on stroke rehabilitation treatment based on Web of Science database and CiinicalTrial.gov in the past 10 years. METHODS： We conducted a quantitative analysis of clinical trial articles regarding stroke rehabilitation published in English from 2003 to 2013 and indexed in the National Institutes of Health Clinical Trials registry and Web of Science databases. Data were downloaded on March 15, 2013. RESULTS： （1） From 2003 to 2013, 2 654 clinical trials investigating stroke were indexed in ClinicalTrials.gov. There were only 58 clinical trials registered in 2003, and there was a marked increase from 2005. A total of 605 clinical trials on the rehabilitation of stroke were conducted in the past 10 years. （2） The analysis showed that most of the trials in the field were registered by North American institutions. With respect to the Asian countries, China and Taiwan Region of China also published a reasonable proportion of the trials, but comparatively speaking, the number of trials is really rare. Most of the interventions were drugs, followed by the devices, and behavioral interventions were ranked third. （3） In the past 10 years, there were 4 052 studies on stroke indexed by Web of Science database. CONCLUSION： From perspective of research progress, we found that the number of clinical trials and papers on stroke rehabilitation has increased significantly in the past 10 years, between them a remarkable positive correlation exists.