Efficacy and safety of Link Natural Sudarshana, an Ayurvedic herbal preparation in COVID-19 patients: A phase II multicenter double-blind randomized placebo-controlled trial.

ETHNOPHARMACOLOGICAL RELEVANCE: In vitro and in vivo studies have shown anti-viral and immunomodulatory actions in components of many traditional medicines. Various constituents of traditional medicines have been found to be effective against coronavirus disease (COVID-19) in several clinical trials and in-silico studies. Sudarshana cúrna, a polyherbal Ayurvedic medicine, has been used over thousands of years for a variety of infectious fevers. AIMS OF THE STUDY: This study aimed to evaluate the efficacy and safety of Link Natural Sudarshana (LNS) tablets, in patients with COVID 19 disease. LNS is a polyherbal preparation comprising 49 medicinal plants included in the Sudarshana cúrna. MATERIALS AND METHODS: A randomized parallel-group double-blind placebo-controlled multi-center phase II clinical trial was conducted in patients with mild to moderate COVID-19 disease. They were randomly allocated to intervention and control groups. The intervention group received LNS tablets whereas the control group received placebo tablets for 10 days or until the patient was discharged from the hospital. All patients received standard symptomatic treatment. The primary outcome, a reduction in mean log viral load was assessed at day 5 of treatment. The secondary outcomes, clinical progression and safety, were assessed by, monitoring changes in symptoms daily on a Likert scale ranging from 1 to 4 and laboratory tests respectively. RESULTS: A total of 171 patients (treatment group 83, control group 88) completed the trial. There were no significant differences between the baseline status of the two groups except that body mass index was significantly higher in the placebo group. The mean log viral load reduction at day 5 was higher in the treatment group (2.20 ± 1.67) compared to the placebo group (1.93 ± 1.80), with a mean difference of -0.278. This difference was not statistically significant at the 5% significant level. Reduction of mean cumulative symptom score, which included 16 symptoms graded according to severity, was higher in the treatment group compared to the placebo group. This difference was not statistically significant. None of the study participants developed hypoxia. Among the 7 lymphopenia patients in the placebo group, 3 continued to have lymphopenia at day 10, whereas 9 lymphopenia patients in the treatment group, reverted to normal counts. C reactive proteins (CRP) showed a greater reduction in the treatment group. None reported adverse effects. No significant changes occurred in hematological and biochemical parameters that assessed safety. CONCLUSIONS: LNS is safe to use in COVID-19 patients and accelerated the decline in viral load, relieved symptoms, reduced CRP levels and reversed lymphopenia earlier, when compared to the placebo.

Awareness of clinical trial registration among healthcare professionals: An observational study.

AIM: Prospective registration in a freely accessible public platform is a key step in the ethical conduct of clinical trials. Little is known of the awareness of clinical trial registration among the scientific community. This study aimed to assess awareness of clinical trial registration among participants attending a medical congress in Sri Lanka. METHODS: Knowledge of trial registration was assessed using a self-administered questionnaire, which spanned domains such as involvement in research, and knowledge and perceptions regarding trial registration. A knowledge score was calculated and correlated with demographic variables. RESULTS: Of 251 survey respondents, 53.4% were male, 74.9% were below the age of 40 years, and 56.6% were currently engaged in research. Registration was considered necessary for trial publication by 73.3%, and 70.5% agreed that trials should be registered prospectively. Most achieved a knowledge score of 'Acceptable' (41%) or 'Good' (19.9%). Mid- or advanced career stages, postgraduate training, current involvement in research, and recent research publications/presentations were correlated with higher knowledge scores (P < 0.05). Beneficial effects considered to be associated with trial registration were access to findings of all trials (61.4%), access to negative results (47.8%), preventing trial duplication (69.3%), and preventing multiple publications (70.1%). Increasing research workload (49.8%), additional restrictions on research conduct (52.2%), and the possibility of 'intellectual theft' (56.2%) were seen as potential negative effects. CONCLUSIONS: Most participants were aware of the need for prospective registration as a requirement for publication of clinical trials. Concerns were expressed regarding several perceived negative effects of trial registration.

Ten years of clinical trial registration in a resource-limited setting: Experience of the Sri Lanka clinical trials registry.

AIM: We describe our experience of the first 10 years at the Sri Lanka Clinical Trials Registry (SLCTR). METHODS: We analyzed all trial records of the SLCTR over the study period. We collected information regarding trial characteristics and completeness of data entry in the SLCTR data set. RESULTS: During the study period, 210 trials (63% of all applications) were registered with the SLCTR. The number of registered trials showed an increasing trend over the years. All trial registrations had complete entries for all the data fields studied. Only 17.6% of the trials were registered retrospectively. All the registered trials were interventional studies, and the majority (87.6%) were randomized controlled trials. A significant proportion of trials (28.6%) were on noncommunicable diseases, and 12.4% were on pregnancy and its outcomes. Several trials (9.5%) were international collaborative studies. A majority of the Principal Investigators (70.9%) were affiliated to a university. Most of the studies (41.9%) were self-funded by the investigators. Details of ethics review committee approval were available for 96.7% of registered trials. Over a third of the registered trials (37.1%) had completed recruitment at the time of analysis. A majority of the trials (72.8%) had updated trial data since registration. CONCLUSIONS: There is a steady increase in the number of trials registered at the SLCTR. Complete entries for all the data fields were seen in all trial registrations. The SLCTR has made a positive contribution to the emergence of a healthy clinical research environment in Sri Lanka.

The Sri Lanka Clinical Trials Registry--moving forward.

The Sri Lanka Clinical Trials Registry (SLCTR) is a Primary Registry in the Registry Network of the World Health Organization's International Clinical Trials Registry Platform (WHO-ICTRP), and regularly feeds data to its Clinical Trials Search Portal. Over the last few years, the SLCTR has been able to achieve its original objective of providing a national trial register for Sri Lankan researchers, but its role has always been more than that of a mere storehouse of trial data. The research landscape is rapidly changing in Sri Lanka, and the SLCTR has been a key stimulus to a resurgent interest in clinical research among the Sri Lankan research community. The SLCTR is working together with its partner stakeholders to facilitate research in the country, and to ensure that clinical trials conducted in Sri Lanka meet the highest ethical and scientific standards.

Establishing the Sri Lanka clinical trials registry.

Recognizing the need for a national body for trial registration, the Sri Lanka Medical Association took up the challenge of setting up the Sri Lanka Clinical Trials Registry. The registry was established in November 2006, the first functioning trial registry in South Asia. The Sri Lanka Clinical Trials Registry is now a primary registry affiliated to the Registry Network of the International Clinical Trials Registry Platform of the World Health Organization. The Sri Lanka Clinical Trials Registry has not been a mere repository for trial data but has also had a positive influence on the research community in Sri Lanka.

Couple characteristics and outcome of therapy in vaginismus.

OBJECTIVE: To describe couple characteristics and outcome of therapy in vaginismus. DESIGN: A prospective before-after intervention descriptive study. SETTING: Department of Physiology, Faculty of Medicine, Colombo, Sri Lanka. METHODS: Fifty six couples with vaginismus, mostly self referrals and referrals from gynaecologists and general practitioners, were treated with a standard cognitive behaviour therapy protocol with before-after assessments of the degree of vaginismus and individual partner self-ratings of the relationship and psychological status (GHQ-30). OUTCOME MEASURES: Success at the end of the therapy was equated to the absence of or only mild vaginismus and, improvement in the couple relationship and psychological status scores. RESULTS: Twenty seven (48%) of the 52 (93%) couples with non-consummation reported failure of coitus following previous non-surgical and surgical interventions. Love marriages (70%), frequent attempts at sex (75%, 3 or 4 times/week) and sexual arousal (women = 86%, men = 89%) characterised couples. Ten men developed sexual problems, mostly erectile failure and premature ejaculation secondarily. Couple therapy enabled penetrative sex in 45 (80.3%). The single prognostic indicator of outcome was the degree of vaginismus at first visit, those with mild and moderate vaginismus (77%) being significantly more likely to establish coitus (p<0.001) and complete the therapy (p<0.001). The couple relationship improved marginally (women p<0.01, men 0.025

0.01) but the psychological status remained unchanged. Dropouts and referrals for psychiatric and marital counselling failed to complete therapy. INTERPRETATION: Couple sex therapy is effective in the management of vaginismus. Health professionals, especially gynaecologists and general practitioners, need to be aware of the problem and the satisfactory outcome of sex therapy.