Sri Lanka Clinical Trials Registry Research Articles

Efficacy and safety of oral ivermectin in the treatment of mild to moderate Covid-19 patients: a multi-centre double-blind randomized controlled clinical trial

BackgroundEvidence on ivermectin as a treatment for Covid-19 is controversial. A Cochrane review concluded that the efficacy and safety of ivermectin is uncertain (evidence up to April 2022) and WHO recommended its use only in the setting of clinical trials. This study aimed to assess the efficacy and safety of oral ivermectin in hospitalized patients with mild to moderate Covid-19.Trial design and methodsA double-blind, randomized placebo-controlled clinical trial was conducted among RT-PCR-confirmed, adults, hospitalised within the first four days of symptoms. Patients received oral ivermectin 24 mg or placebo daily for five days. RT-PCR was repeated on days five and ten. Clinical progression was monitored using the World Health Organization Clinical Progression Scale. Serum ivermectin levels were measured on days three, five, and seven. The primary outcome was the difference in the viral load between day zero and ten in the two groups.ResultsOut of 1699 patients screened, 249 underwent randomization and 127 received ivermectin, and 122 placebo. D10 median viral load for E gene (IQR) was 2,000 copies/mL (100 − 20,500) with ivermectin (n = 80) and 4,100 copies/mL (1,000–65,600) with placebo (n = 81, p = 0.028), per protocol analysis. The difference in Log viral load between day zero and ten between ivermectin and placebo was 3.72 and 2.97 respectively (p = 0.022). There was no significant difference in the WHO clinical progression scale or the adverse effects. Ivermectin blood levels taken before or with meals were not significantly different. Only 7 and 17 patients achieved blood levels above 160ng/ML and 100ng/ML respectively and they did not achieve a significantly lower viral load.ConclusionAlthough ivermectin resulted in statistically significant lower viral load in patients with mild to moderate Covid-19, it had no significant effect on clinical symptoms.Trial registration numberSLCTR/2021/020, Sri Lanka Clinical Trials Registry. 19/07/2021.

The impact of a culturally adapted lifestyle intervention on the glycaemic profile of mothers with GDM one year after delivery – a community-based, cluster randomized trial in Sri Lanka

BackgroundA woman with a history of GDM has a high risk of developing type two diabetes (T2DM) in her future life. Lifestyle modifications are known to attenuate the progression of GDM to T2DM. Therefore, the aim of this study was to assess the impact of a simple, cost effective, culturally acceptable lifestyle intervention programme on the trajectory towards T2DM in women with a history of GDM.MethodsThis cluster randomized trial was conducted in 100 postpartum women in three selected districts of Sri Lanka. The subjects were divided into intervention (n = 50) and control groups (n = 50) by cluster randomization method. A culturally adapted protocol (comprised of dietary and physical activity modifications) was administered to the intervention group. The glycemic profile was assessed using fasting and 2-hour post-OGTT plasma glucose and HbA1c, and insulin resistance by HOMA-IR at baseline and after one year of intervention.ResultsThe mean age (SD) of the subjects in the intervention and control groups were 33.0 (5.1) and 34.3 (6.5) years respectively. All glycemic and insulin resistance parameters (i.e. Fasting plasma glucose- FPG, 2-hour post-OGTT plasma glucose, HbA1c and HOMA-ir) were comparable (p > 0.05) between the two groups at baseline. FPG, 2 h post OGTT, HbA1c and HOMA-ir values between intervention vs. control (p) at 12 months were 87.3 vs. 123.2 (< 0.01); 106.5 vs. 156.1 (0.01); 5.3 vs. 6.8 (< 0.01) and 0.9 vs. 2.3 (< 0.01) respectively. All glycemic parameters showed a significant reduction in the intervention group at 12 months compared to baseline. In contrast, the control group showed a significant increase in FPG, 2-hour post-OGTT plasma glucose and HbA1c at 12 months compared to baseline. In multiple linear regression model adjusted for age, parity and family history, the control group showed an approximately 33 times risk of developing insulin resistance compared to the intervention group.ConclusionThe culturally acceptable and individualized lifestyle intervention was able to produce remarkable reductions in glycaemic and insulin resistance parameters among postpartum women with a history of GDM.Trial registrationEthical clearance was obtained from the Ethics Review Committee of the University of Sri Jayewardenepura, Sri Lanka (ERC 52/14), Sri Lanka Clinical trial registration number Sri Lanka Clinical Trials Registry (SLCTR/2015/021 date 25.09.2015).

Efficacy and safety of deferoxamine, deferasirox and deferiprone triple iron chelator combination therapy for transfusion-dependent β-thalassaemia with very high iron overload: a protocol for randomised controlled clinical trial

IntroductionDespite the improvement in medical management, many patients with transfusion-dependent β-thalassaemia die prematurely due to transfusion-related iron overload. As per the current guidelines, the optimal chelation of iron cannot be...

Physiotherapy training and education prior to elective Caesarean section and its impact on post-natal quality of life: a secondary analysis of a randomized controlled trial

BackgroundCaesarean section (CS) is associated with numerous complications that lead to the delayed return to functional activities that have a negative influence on the post-natal quality of life (QOL). It is evident that providing regular evidence-based physiotherapy training and education prior to elective CS helps to enhance the post-natal QOL by improving physical, mental, social, and general well-being. The purpose of this study was to examine the effectiveness of physiotherapy training and education prior to elective CS on post-natal QOL.MethodsThis single-blind parallel randomized controlled study was carried out at De Soysa Hospital for Women (DSHW), Colombo. The study enrolled 54 women who were scheduled to undergo elective CS. The intervention group (n = 27) of women received physiotherapy training and education, while the control group (n = 27) received standard nursing care. In addition to the primary outcome measures, post-natal QOL was measured. The results were examined using descriptive statistics and the independent samples t-test in IBM SPSS 20.ResultsThe intervention group showed a higher post-natal QOL for the domains of physical function, role limitation due to physical health, energy/fatigue, and pain than the control group (p < 0.05).ConclusionPhysiotherapy training and education prior to elective CS play a pivotal role in improving the physical health-related domains of QOL following CS.Trial RegistrationThe Sri Lanka Clinical Trials Registry (https://www.slctr.lk). Registration number: SLCTR/2019/029-APPL/2019/028; Registration date: 6th of September 2019.

The incidence and risk factors of postpartum diabetes in women from Bangladesh, India and Sri Lanka (South Asia) with prior gestational diabetes mellitus: Results from the LIVING study

AimTo study, the incidence and risk factors for postpartum diabetes (DM), in women with gestational diabetes mellitus (GDM) from South Asia (Bangladesh, India and Sri Lanka), followed for nearly two years after delivery. MethodsWomen with prior GDM diagnosed using IADPSG criteria were invited at 19 centres across Bangladesh, India and Sri Lanka for an oral glucose tolerance test (OGTT) following childbirth, and were enrolled in a randomized controlled trial. The glycaemic category (outcome) was defined from an OGTT based on American Diabetes Association criteria. ResultsParticipants (n = 1808) recruited had a mean ± SD age of 31.0 ± 5.0 years. Incident DM was identified, between childbirth and the last follow-up, in 310 (17.1 %) women [incidence 10.75/100 person years], with a median follow-up duration of 1.82 years after childbirth. Higher age, lower education status, higher prior pregnancy count, prior history of GDM, family history of DM, and postpartum overweight/obese status were significantly associated with incident DM. Women in Bangladesh had a higher cumulative incidence of DM [16.49/100 person years] than in Sri Lanka [12.74/100 person years] and India [7.21/100 person years]. ConclusionsA high incidence of DM was found in women with prior GDM in South Asia, with significant variation between countries. Women from Bangladesh had a significantly higher pregnancy count, family history of DM and overweight/obese status, despite having significantly lower age, which could be responsible for their higher rates of DM.Registration of this study: The study was registered with the Clinical Trials Registry of India (CTRI/2017/06/008744), Sri Lanka Clinical Trials Registry (SLCTR/2017/001), and ClinicalTrials.gov (NCT03305939).

Ethics of research

Ethics of research

Community-based alcohol education intervention (THEATRE) study to reduce harmful effects of alcohol in rural Sri Lanka: design and adaptation of a mixed-methods stepped wedge cluster randomised control trial

IntroductionAlcohol consumption is a leading cause of mortality, morbidity and adverse social sequelae in Sri Lanka. Effective community-based, culturally adapted or context-specific interventions are required to minimise these harms. We...

Impact of a clinical pharmacist on optimising the quality use of medicines according to the acute coronary syndrome (ACS) secondary prevention guidelines and medication adherence following discharge in patients with ACS in Sri Lanka: a prospective non-randomised controlled trial study protocol

ObjectivesEnsuring quality use of medicines (QUM) through clinical pharmacy services can improve therapeutic outcomes of patients diagnosed with acute coronary syndrome (ACS). The major objective of this study is to...

Effects of a Lifestyle Intervention to Prevent Deterioration in Glycemic Status Among South Asian Women With Recent Gestational Diabetes

Women with recent gestational diabetes (GDM) have increased risk of developing type 2 diabetes. To investigate whether a resource-appropriate and context-appropriate lifestyle intervention could prevent glycemic deterioration among women with recent GDM in South Asia. This randomized, participant-unblinded controlled trial investigated a 12-month lifestyle intervention vs usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh. Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT) 3 to 18 months postpartum. They were enrolled from November 2017 to January 2020, and follow-up ended in January 2021. Data were analyzed from April to July 2021. A 12-month lifestyle intervention focused on diet and physical activity involving group and individual sessions, as well as remote engagement, adapted to local context and resources. This was compared with usual care. The primary outcome was worsening category of glycemia based on OGTT using American Diabetes Association criteria: (1) normal glucose tolerance to prediabetes (ie, impaired fasting glucose or impaired glucose tolerance) or type 2 diabetes or (2) prediabetes to type 2 diabetes. The primary analysis consisted of a survival analysis of time to change in glycemic status at or prior to the final patient visit, which occurred at varying times after 12 months for each patient. Secondary outcomes included new-onset type 2 diabetes and change in body weight. A total of 1823 women (baseline mean [SD] age, 30.9 [4.9] years and mean [SD] body mass index, 26.6 [4.6]) underwent OGTT at a median (IQR) 6.5 (4.8-8.2) months postpartum. After excluding 160 women (8.8%) with type 2 diabetes, 2 women (0.1%) who met other exclusion criteria, and 49 women (2.7%) who did not consent or were uncontactable, 1612 women were randomized. Subsequently, 11 randomized participants were identified as ineligible and excluded from the primary analysis, leaving 1601 women randomized (800 women randomized to the intervention group and 801 women randomized to usual care). These included 600 women (37.5%) with prediabetes and 1001 women (62.5%) with normoglycemia. Among participants randomized to the intervention, 644 women (80.5%) received all program content, although COVID-19 lockdowns impacted the delivery model (ie, among 644 participants who engaged in all group sessions, 476 women [73.9%] received some or all content through individual engagement, and 315 women [48.9%] received some or all content remotely). After a median (IQR) 14.1 (11.4-20.1) months of follow-up, 1308 participants (81.2%) had primary outcome data. The intervention, compared with usual care, did not reduce worsening glycemic status (204 women [25.5%] vs 217 women [27.1%]; hazard ratio, 0.92; [95% CI, 0.76-1.12]; P = .42) or improve any secondary outcome. This study found that a large proportion of women in South Asian urban settings developed dysglycemia soon after a GDM-affected pregnancy and that a lifestyle intervention, modified owing to the COVID-19 pandemic, did not prevent subsequent glycemic deterioration. These findings suggest that alternate or additional approaches are needed, especially among high-risk individuals. Clinical Trials Registry of India Identifier: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry Identifier: SLCTR/2017/001; and ClinicalTrials.gov Identifier: NCT03305939.

The impact of physical exercises with elements of dance movement therapy on the upper limb grip strength and functional performance of elderly wheelchair users living in nursing homes \u2013 a randomized control trial

IntroductionOver the last few decades, the quality of care and the quality of life of nursing home (NH) residents have significantly improved, but insufficient physical activity and social involvement still represent substantial challenges in modern nursing facilities. The main aim of this research was to assess the influence of physical exercises with dance movement therapy (DMT) elements on strength and other fitness components of the upper limbs and the overall functional performance of NH residents in wheelchairs compared to standard exercise programmes and usual care.MethodThe study participants were persons aged 68–85 who lived in NH and used manual wheelchairs as a primary means of mobility. Individuals meeting the inclusion criteria were assigned to one of the three groups: Group 1, basic exercise/BE group (n = 55); group 2, physical exercises with elements of dance movement therapy/PED group (n = 55); and group 3, control group, usual care/CO group (n = 55). The intervention for both exercising groups consisted of a 30-min session, two times a week, for 12 weeks in total. Outcome assessments were performed at baseline, 12 weeks after baseline (immediately after the intervention) and 24 weeks after baseline (12 weeks after the intervention). The main outcome was observed for hand grip strength (HGS), while secondary outcomes for box and block test (BBT), arm curl test (ACT), back scratch test (BS), chair sit-and-reach (CSR), peak expiratory flow (PEF), Barthel Index (BI), Berg Balance Scale (BBS) and the range of motion of the shoulder.ResultsPrior to the start of the exercise programmes, all the tested groups were homogeneous. After 12 weeks the PED group presented higher statistically significant scores in HGSL, BBT, ACT, BS, CSR, BI, BBS: p < 0.001 and HGSR: p = 0.01, compared to the BE group. After 24 weeks from the beginning of the intervention the comparison between the PED group and the BE group showed statistically significant differences (p < 0.001) in favour of PED group in almost all areas: HGSR, HGSL, BBT: ACT, PEF, BS, CSR, BI. After 12 and 24 weeks both intervention groups performed better than the CO in all measures except for Katz ADL and shoulder extension.ConclusionTwelve weeks of physical exercises had beneficial effects on the strength and fitness of the upper limbs and overall functional performance in both exercise groups. This study demonstrated that group performing physical exercises with elements of DMT obtained statistically better scores in the majority of analysed domains than other groups.Trial registrationThe study was registered in the Sri Lanka Clinical Trials Registry (Registration Number - SLCTR/2018/014 - Date of Registration 16/05/2018. Accessed on https://slctr.lk/trials/1045).

Clinical trials landscape in Sri Lanka

Sri Lanka is an ideal destination for the global clinical trial industry due to its favorable national policies, growing economy, and rapid digitalization directly influencing the increasing global market size of clinical trials. Its comprehensive primary health care coverage, educated population, free standard of care, non-communicable disease burden equals to western countries, qualified medical practitioners, and a core of competent and committed clinical researchers combined with its population’s proficiency in English also make this South Asian nation a potentially excellent regional clinical trials destination. Making an environment favorable to research partnership while guaranteeing the safe and ethical conduct of clinical trials has been a repetitive subject for conversation and discussion in the nation. A robust regulatory framework and ethical reviewing process have minimized legal loopholes ensuring the rights, safety, and well-being of trial participants that are protected. The Sri Lanka Clinical Trials Registry is a non-revenue driven registry and it can be considered a key stimulus to the ongoing discussions on clinical trials in Sri Lanka. Moreover, the adoption of new technology in clinical research and the rise of the pharmaceutical industry encourages and creates opportunities for more clinical trials to be conducted in Sri Lanka which, in turn, influences the growth of the industry.

The Effects of a Lifestyle Intervention to Prevent Deterioration in Glycaemic Status Among South Asian Women with Recent Gestational Diabetes Mellitus: A Randomised Control Trial

Background: Women with recent gestational diabetes mellitus (GDM) have increased risk of developing type 2 diabetes mellitus (T2DM). We aimed to determine whether a resource- and culturally-appropriate lifestyle intervention could prevent glycaemic deterioration in South Asia.Methods: This was an open-label parallel-group randomised trial. Women with GDM from 19 urban hospitals in India, Sri Lanka and Bangladesh underwent an oral glucose tolerance test (OGTT) 3-18 months post-partum. Those without T2DM were randomised to a 12-month lifestyle intervention focused on diet and physical activity or usual care. The primary outcome was the proportion with worsening category of glycaemia based on OGTT using American Diabetes Association criteria: 1) normal glucose tolerance to pre-diabetes (impaired fasting glucose and/or impaired glucose tolerance) or T2DM; or 2) pre-diabetes to T2DM. Secondary outcomes included new-onset T2DM, and change in body weight.Findings: 1823 women underwent OGTT at a median of 6·9 months post-partum. After excluding 162 (8·9%) with T2DM, 1612 (37·5% with pre-diabetes and 62·5% with normoglycaemia) were randomised between November 2017 and January 2020. Baseline mean age was 30·9 years (SD 4·9), mean BMI was 26·6 kg/m 2 (SD 4·7). Among participants randomised to the intervention, 79·7% were exposed to all programme content although pandemic lockdowns impacted the delivery model. After 14·5 months median follow-up, 1308 (81·2%) participants had primary outcome data. The intervention, compared to usual care, did not reduce worsening glycaemic status (25·5% vs. 27·1%; hazard ratio, 0·92 [95% CI: 0·76‒1·12]) or any secondary outcome. There was no evidence of heterogeneity of intervention effect by baseline characteristics. Interpretation: A large proportion of South Asian women in urban centres develop dysglycaemia soon after a GDM-affected pregnancy. A low-intensity lifestyle intervention, substantially modified due to the COVID-19 pandemic, did not prevent subsequent deterioration in glycaemic status. Alternate or additional approaches are needed, especially among high-risk individuals.Trial Registration: Clinical Trials Registry of India (CTRI/2017/06/008744), Sri Lanka Clinical Trials Registry (SLCTR/2017/001) and ClinicalTrials.gov (NCT03305939).Funding: Global Alliance for Chronic Disease grants from the Indian Council of Medical Research (NO.58/1/1/GACD/NCD-II) and Australian National Health and Medical Research Council (1093171). Additional funding was received from USV Pharmaceuticals Ltd. and Lupin Pharmaceuticals Ltd. for sub-studies (data not reported here).Declaration of Interest: None to declare. Ethical Approval: The study protocol was approved by Human Research Ethics Committees of the All India Institute of Medical Sciences (India), icddr,b (Bangladesh), Faculty of Medicine, University of Kelaniya (Sri Lanka) and the University of Sydney (Australia)

Lifestyle InterVention IN Gestational diabetes (LIVING) in India, Bangladesh and Sri Lanka: protocol for process evaluation of a randomised controlled trial

IntroductionThe development of type 2 diabetes mellitus disproportionately affects South Asian women with prior gestational diabetes mellitus (GDM). The Lifestyle InterVention IN Gestational diabetes (LIVING) Study is a randomised controlled...

Vitamin D supplementation in obese Sri Lankan children: a randomized controlled trial

BackgroundMicronutrient deficiencies are identified among obese individuals. Vitamin D deficiency (VDD) is prevalent in obese children, and is hypothesized to cause insulin resistance and metabolic abnormalities. This study aimed to determine the effect of vitamin D supplementation on obesity and related metabolic abnormalities among obese Sri Lankan children with VDD.MethodsA triple-blind randomized controlled trial was conducted among vitamin D deficient (< 20 ng/ml), obese children (n = 96), randomly allocated to three intervention arms - treatment arm receiving weekly vitamin D2 50,000 IU; supplementation arm receiving 2500 IU weekly and control arm, receiving placebo. Anthropometry, percentage fat mass (%FM) and blood pressure were assessed and fasting blood glucose, fasting insulin, lipid profile, aspartate transaminase (ALT), alanine transaminase (AST), vitamin D, parathyroid hormone (PTH) and hs-CRP and OGTT with 2-h random blood glucose and insulin was performed at baseline and after 24 weeks of treatment. Ethics Review Committee of Faculty of Medicine, University of Colombo approved the protocol.ResultsWaist circumference Z-score, %FM and serum calcium significantly improved across all three arms, ALT significantly improved in treatment and supplementation arms while, BMI Z-score, PTH and vitamin D significantly improved in the treatment arm. Biceps (p = 0.035) and subscapular (0.048) skin fold thickness, vitamin D (p = 0.004) and ALT (p = 0.012) significantly improved in the treatment arm.ConclusionsA strict dietary and physical activity regimen could improve some of the anthropometric, body composition and metabolic profiles, but high dose vitamin D, enhances those improvements. Therefore high dose vitamin D seems to potentiate management outcomes of obese children with vitamin D deficiency.Trial registrationThe study was registered at the Sri Lanka Clinical Trials Registry (SLCTR/2015/017) on 12th September 2015 at https://slctr.lk/trials/slctr-2015-017.

School-based physical activity intervention in 11-13-year-olds: study protocol for cluster randomized controlled trial

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Targeted strategies to enhance regular physical activity appear to be promising to promote health and well-being of adolescents. This article reports the design of a cluster randomised controlled trial to evaluate the effectiveness of a school-based physical activity programme on the rate and duration of moderate-to-vigorous physical activity, sitting time including screen time, and health-related physical fitness parameters among 11-13 year-old adolescents.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; This is a cluster randomized controlled trial conducted in 360 adolescents from government schools in the Colombo Municipal Council area, Sri Lanka. An individual school was considered as a unit of randomization and the 12 selected schools were randomly assigned to one of two groups: control (six schools) and intervention groups (six schools). The intervention group follows a physical activity programme for 30 minutes on three school days per week, for three consecutive months in addition to the standard practice. The primary outcomes are moderate-to-vigorous physical activity rate and duration and sitting time including screen time. Secondary outcomes are the health-related physical fitness parameters: cardiovascular fitness, muscle fitness and flexibility, and body composition. All the outcomes are measured at baseline and three-months following the intervention.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Discussion:&lt;/strong&gt; The outcomes of this study will be an evidence-based intervention programme with the potential to be incorporated into the national education system thus promoting health and well-being of adolescents in Sri Lanka.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Trial Registration&lt;/strong&gt;&lt;strong&gt;: &lt;/strong&gt;Registered at the Sri Lanka Clinical Trials Registry (SLCTR/2018/028).&lt;/p&gt;

The effect of youths as change agents on cardiovascular disease risk factors among adult neighbours: a cluster randomised controlled trial in Sri Lanka

BackgroundMobilising non-professional health workers has been successful in improving community health, but the effectiveness of an education program targeting youths in a community-based approach remains unclear. The objective of this study was to investigate the effect of an intervention with youth on cardiovascular disease risk factors of community adults.MethodsA 12-month cluster randomised trial was conducted in a semi-urban area of Colombo in Sri Lanka. Facilitators trained youth club members aged 15–29 years to assess cardiovascular disease risk factors and take actions in the community to address relevant issues. The control group received no intervention. Body weight and blood pressure as primary outcomes and lifestyle of adults as secondary outcomes were measured pre- and post-intervention. Multilevel linear and logistic regressions were used to assess the effects of the intervention on changes in continuous and binary outcomes, respectively, from baseline to endpoint.ResultsOf 512 participants at baseline, 483 completed the final assessment after the intervention. Regarding primary outcomes, the intervention group showed a significantly greater decrease in body weight after intervention than the control group. The mean (95% confidence interval) difference of body weight change for intervention versus control group was − 2.83 kg (− 3.31, − 2.35). There was no statistically significant difference in blood pressure between the two groups. Turning to the secondary outcomes, in diet, the intervention group had a higher probability of consuming at least one serving/day of fruits (p = 0.02) and a lower probability of consuming snacks twice/day or more (p < 0.001) than the control group.ConclusionsAn intervention employing youths as change agents was effective in lowering body weight among community adults in Sri Lanka.Trial registrationTrial registration number: SLCTR/2017/002, Name of registry: Sri Lanka Clinical Trials Registry, Date of registration: 19th January 2017, Date of enrolment of the first participant to the trial: 1st February 2017.

A lifestyle intervention programme for the prevention of Type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus [LIVING study]: protocol for a randomized trial

This study aims to determine whether a resource- and culturally appropriate lifestyle intervention programme in South Asian countries, provided to women with gestational diabetes (GDM) after childbirth, will reduce the incidence of worsening of glycaemic status in a manner that is affordable, acceptable and scalable. Women with GDM (diagnosed by oral glucose tolerance test using the International Association of the Diabetes and Pregnancy Study Groups criteria) will be recruited from 16 hospitals in India, Sri Lanka and Bangladesh. Participants will undergo a repeat oral glucose tolerance test at 6 ± 3 months postpartum and those without Type 2 diabetes, a total sample size of 1414, will be randomly allocated to the intervention or usual care. The intervention will consist of four group sessions, 84 SMS or voice messages and review phone calls over the first year. Participants requiring intensification of the intervention will receive two additional individual sessions over the latter half of the first year. Median follow-up will be 2 years. The primary outcome is the proportion of women with a change in glycaemic category, using the American Diabetes Association criteria: (i) normal glucose tolerance to impaired fasting glucose, or impaired glucose tolerance, or Type 2 diabetes; or (ii) impaired fasting glucose or impaired glucose tolerance to Type 2 diabetes. Process evaluation will explore barriers and facilitators of implementation of the intervention in each local context, while trial-based and modelled economic evaluations will assess cost-effectiveness. The study will generate important new evidence about a potential strategy to address the long-term sequelae of GDM, a major and growing problem among women in South Asia. (Clinical Trials Registry of India No: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry No: SLCTR/2017/001; and ClinicalTrials.gov Identifier No: NCT03305939).

Challenges of Costing a Surgical Procedure in a Lower-Middle-Income Country.

It is vital to enquire into cost of health care to ensure that maximum value for money is obtained with available resources; however, there is a dearth of information on cost of health care in lower-middle-income countries (LMICs). Our aim was to develop a reproducible costing method for three routes of hysterectomy in benign uterine conditions: total abdominal (TAH), non-descent vaginal (NDVH) and total laparoscopic hysterectomy (TLH). A societal perspective with a micro-costing approach was applied to find out direct and indirect costs. A total of 147 patients were recruited from a district general hospital (Mannar) and a tertiary care hospital (Ragama). Costs incurred from preoperative period to convalescence included direct costs of labour, equipment, investigations, medications and utilities, and indirect costs of out-of-pocket expenses, productivity losses, carer costs and travelling. Time-driven activity-based costing was used for labour, and top-down micro-costing was used for utilities. The total cost [(interquartile range), number] of TAH was USD 339 [(308-397), n = 24] versus USD 338 [(312-422), n = 25], NDVH was USD 315 [(316-541), n = 23] versus USD 357 [(282-739), n = 26] and TLH was USD 393 [(338-446), n = 24] versus USD 429 [(390-504), n = 25] at Mannar and Ragama, respectively. The direct cost of TAH, NDVH and TLH was similar between the two centres, whilst indirect cost was related to the setting rather than the route of hysterectomy. The costing method used in this study overcomes logistical difficulties in a LMIC and can serve as a guide for clinicians and policy makers in similar settings. The study was registered in the Sri Lanka clinical trials registry (SLCTR/2016/020) and the International Clinical Trials Registry Platform (U1111-1194-8422) on 26 July 2016.

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

We describe our experience of the first 10 years at the Sri Lanka Clinical Trials Registry (SLCTR). 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. 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. 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.

Evaluation of pharmacodynamic properties and safety of Cinnamomum zeylanicum (Ceylon cinnamon) in healthy adults: a phase I clinical trial

BackgroundCinnamon is considered as a treatment for many ailments in native medicine. Evidence suggests that Cinnamomum zeylanicum (CZ) has anti-microbial, anti-parasitic, anti-oxidant, blood glucose lowering properties and beneficial cardiovascular effects. The present study aims to evaluate Pharmacodynamic properties and safety of CZ in healthy adults using a Phase I Clinical Trial.MethodsThis phase I clinical trial was conducted at the Department of Pharmacology, Faculty of Medicine, University of Colombo, Sri Lanka. Thirty healthy adults were recruited for the study, conducted for a period of 3 months, with the dose of CZ (water extract) increased at monthly intervals (85 mg, 250 mg and 500 mg). Data collection was carried out at baseline and during each monthly follow up visit. Anthropometric, clinical and biochemical assessments were done at baseline and during follow up. Adverse effects and drug compliance was also evaluated.ResultsTwenty eight subjects completed the three months follow up. Mean age was 38.8 ± 10.4 years and 50% were males. There were no significant changes in the anthropometric parameters during the three months follow up. Both systolic and diastolic blood pressure reduced significant during the 1st month and this reduction was sustained throughout follow up. Full blood count, renal function tests, liver function tests, fasting blood glucose, HDL-c, VLDL-d and triglycerides remained within the normal range without any significant alteration during the 3 months. A significant reduction in the TC (p < 0.05) and LDL-c (p < 0.001) was noted at the end of the 3 months follow up period. There were no serious adverse effects (including hypersensitivity) noted. In two participants dyspepsia necessitated the discontinuation of study participation. Drug compliance was between 85 and 95% during the study period.ConclusionsThis is the first phase I clinical trial in health adults evaluating efficacy and safety of CZ. Our results demonstrate no significant side effects and toxicity of CZ, including hepatotoxicity and anti-coagulation properties. CZ demonstrated beneficial anti-hyperlipidaemic and blood pressure lowering effects among healthy adults. Further studies with larger samples and longer durations may be able to elucidate other side effects and better describe the pharmacodynamic properties.Trial registrationSLCTR/2013/001 (Sri Lanka Clinical Trials Registry: http://www.slctr.lk/trials/106) (Date of Registration: 01/01/2013).