scholarly journals Practical considerations in the use of a porcine model (Sus scrofa domesticus) to assess prevention of postoperative peritubal adhesions

2019 ◽  
Author(s):  
Claudio Peixoto Crispi ◽  
Claudio Peixoto Crispi ◽  
Fernando Luis Fernandes Mendes ◽  
Claudio Moura de Andrade ◽  
Leon Cardeman ◽  
...  
Keyword(s):  
Porcine Model ◽  
Adhesion Formation ◽  
Control Group ◽  
Efficacy And Safety ◽  
Animal Suffering ◽  
Peritoneal Adhesions ◽  
Injured Area ◽  
Histopathological Evaluation ◽  
Strong Adhesion ◽  
Postoperative Problem

ABSTRACTInfertility has been a common postoperative problem caused by peritoneal adhesions. Since several prophylactic agents have recently shown promising preliminary results, more complete studies comparing their real efficacy and safety are needed urgently. The aim of this study was to investigate and describe practical considerations of a porcine model that can be used to assess such prophylactic agents. First, 10 healthy 5½ months old female pigs (24.3 – 31.3 Kg) underwent a standardized laparoscopy to provoke peritubal adhesion formation without prophylactic agents. After 30 days, a second-look laparoscopy was performed to evaluate adhesions and perform adnexectomy for histopathological evaluation. Adhesions at different sites were classified by grade, for which the scores range from 0 (no adhesion) to 3 (very strong vascularized adhesions), and also by area, with scores ranging from 0 (no adhesion) to 4 (>75% of the injured area). The histopathological evaluation of the distal uterine horns, oviducts and ovaries were compared withthose from a control group of six healthy pigs with no previous surgery. Biological samples were collected to assess vitality, inflammation and renal, hepatic and hematopoietic systems. There were small (but significant) changes in serum albumin (P=0.07), globulin (P=0.07), C-reactive protein (P=0.011), fibrinogen (P=0.023) and bilirubin (P<0.01) after 30 days, but all values were within the normal range. No inflammation or abscess formation was observed, but different degrees of adhesion were identified. The estimated occurrence of adhesion (scores >0) and of strong / very strong adhesion (scores >1) was 75% (95% CI: 55 – 94.9) and 65% (95% CI: 45 – 85), respectively. The porcine model represents a useful animal platform that can be used to test the efficacy and safety of candidate prophylactic agents intended to prevent postoperative peritubal adhesions formation. We present several practical considerations and measures that can help to minimize animal suffering and avoid problems during such experiments.

scholarly journals Hypoxia-preconditioned mesenchymal stem cells attenuate peritoneal adhesion through TGF-β inhibition

2020 ◽  
Vol 39 (2) ◽  
pp. 97
Author(s):  
Setyo Trisnadi ◽  
Adi Muradi Muhar ◽  
Agung Putra ◽  
Azizah Retno Kustiyah
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Rat Model ◽  
Adhesion Formation ◽  
Enzyme Linked Immunosorbent Assay ◽  
Control Group ◽  
Control Group Design ◽  
Peritoneal Adhesions ◽  
Hypoxic Conditions ◽  
Post Test

<p>Background<br />Peritoneal adhesions (PAs) are generally described as fibrous bands between intra-abdominal organs following an abdominal surgical operation. The definitive treatments of PAs are currently ineffective yet. Hypoxia-mesenchymal stem cells (H-MSCs) have a higher capability to survive at the site of injury than normoxia-MSCs (N-MSCs) to repair injured tissue without fibrosis. This study aimed to analyze the effect of H-MSCs in controlling formation of PAs by reducing TGF-β level in a rat model. <br /><br />Methods <br />A study of post-test only control group design was conducted, involving eighteen PA rat models weighing 250 ± 25 g that were randomly assigned into 3 groups, comprising control group (C), and groups T1 and T2 receiving H-MSC treatment at doses of 3 x 106 and 1.5 x 106, respectively. To induce H-MSCs, MSCs were incubated in hypoxic conditions at 5% O2 and 37oC for 24 hours. Expression level of TGF-β was analyzed by enzyme-linked immunosorbent assay (ELISA) at 450 nm and adhesion formation was described macroscopically. The Kruskal-Wallis variance analysis was used to analyze significant differences among the groups.<br /><br />Results<br />The results of this study showed that H-MSCs in group T1 inhibited TGF-β expression significantly on day 8 (p&lt;0.001) and day 14 (p&lt;0.05). Moreover, there was almost no adhesion apparent following H-MSC administration in group T1. <br /><br />Conclusions<br />Based on this study, we conclude that H-MSCs may attenuate PA formation following inhibition of TGF-β expression in the PA rat model.</p>

scholarly journals Prevention of postoperative peritoneal adhesions by O-carboxymethyl chitosan in a rat cecal abrasion model

2010 ◽  
Vol 33 (4) ◽  
pp. 254 ◽  
Author(s):  
Dejuan Wang ◽  
Jiacong Mo ◽  
Shirong Pan ◽  
Haofan Chen ◽  
Huanglin Zhen
Keyword(s):  
Adhesion Formation ◽  
Inflammatory Cells ◽  
Carboxymethyl Chitosan ◽  
Saline Control ◽  
Control Group ◽  
Sprague Dawley ◽  
Peritoneal Adhesions ◽  
Tissue Samples ◽  
Midline Laparotomy ◽  
Peritoneal Adhesion Formation

Purpose: Post-surgial adhesion formation can result in significant morbidity and mortality. N,O-carboxymethyl chitosan (N,O-CMC) has been previously shown to be effective in the prevention of postsurgical adhesion formation. In this study, we evaluated the ability of O-carboxymethyl chitosan (O-CMC), another chitosan derivative generated by carboxymethylation of chitosan's oxygen centers, to reduce postsurgical adhesion development. Methods: Twenty male Sprague-Dawley rats (250 ± 20 g) were divided into two equal groups: O-CMC group and saline (control) group. All rats underwent a midline laparotomy and the cecum was abraded to cause petechial hemorrhages. Following peritoneal injections of either saline or O-CMC, the incisions were closed. Seven days after surgery, the animals were killed and adhesion formation was scored. Tissue samples from the adhesions were examined histochemically. Results: Adhesion formation was significantly decreased in the O-CMC group (P < .001) in comparison with the control group. Furthermore, significantly less collagen (P < .001) and fewer inflammatory cells and fibroblasts were detected in the O-CMC-treated animals. Additionally, a significantly (P < .05) lower level of TGF-β1 expression was found in the O-CMC group. Conclusion: O-CMC appears to be effective in the prevention of postoperative peritoneal adhesion formation, which may be attributed to decreased accumulation of inflammatory cells and fibroblasts and reduced collagen synthesis.

Peritoneal Fluid and Plasma Fibrinolytic Activity in Women with Pelvic Inflammatory Disease

1992 ◽  
Vol 68 (02) ◽  
pp. 102-105 ◽  
Author(s):  
P J Dörr ◽  
E J P Brommer ◽  
G Dooijewaard ◽  
H M Vemer
Keyword(s):  
Pelvic Inflammatory Disease ◽  
Inflammatory Disease ◽  
Peritoneal Fluid ◽  
Fibrinolytic Activity ◽  
Degradation Products ◽  
Adhesion Formation ◽  
High Rate ◽  
Control Group ◽  
The Difference ◽  
Fibrinolytic Parameters

SummaryPrevious studies have shown that the fibrinolytic activity of peritoneum is depressed in local inflammation. We measured fibrinolytic parameters in peritoneal fluid and in plasma of 10 women with pelvic inflammatory disease (PID). Nine women, in whom laparoscopy for sterilisation was performed, served as a control group.In the peritoneal fluid of women with PID, PAI-Ag, t-PA-Ag and u-PA-Ag were many times higher than in the control group. In contrast to the antigens which may be present in inert complexes, the potentially active compounds, measured as t-PA activity and plasmin-activable scu-PA, were not significantly different in the two groups, and in none of the samples was the active enzyme tcu-PA detectable. Nevertheless, the mean peritoneal fluid TDP and FbDP concentrations were about twenty times higher in the PID group than in the control group. In plasma of PID patients, none of the parameters except u-PA-Ag differed from those in the control group. The difference between control and patient plasma u-PA-Ag was statistically significant, but too small to attach any relevance to the observation.Our data suggest that, in contrast to the classical concept of decreased fibrinolytic activity as a cause of adhesion formation, intraperitoneal fibrinolysis is enhanced in peritoneal inflammation through stimulation of the local production of t-PA and u-PA. Despite concomitant production of PAI, fibrinolysis occurs at a high rate, resulting in high levels of fibrin degradation products. Since this activated fibrinolysis does not meet the demand, therapeutic enhancement should be considered to prevent adhesions.

Effects of methylene blue, indigo carmine solution and autologous erythrocyte suspension on formation of adhesions after injection into rats

Reproduction ◽  
2000 ◽  
pp. 225-229 ◽  
Author(s):  
A Gul ◽  
C Kotan ◽  
I Dilek ◽  
T Gul ◽  
A Tas ◽  
...  
Keyword(s):  
Methylene Blue ◽  
Macrophage Activation ◽  
Indigo Carmine ◽  
Adhesion Formation ◽  
Albino Rats ◽  
Erythrocyte Suspension ◽  
Peritoneal Adhesions ◽  
Tubal Patency ◽  
Macrophage Activity ◽  
Group Score

The aim of this study was to determine whether autologous erythrocyte suspension can be used as a dye for evaluation of tubal patency and whether it has any advantages over methylene blue or indigo carmine solutions. Reproductively healthy female nulliparous Wistar Albino rats (n = 30), aged 6 months, mass 165-195 g, were assigned randomly to three groups. Rats received a 1 ml i.p. injection of 5% (w/v) methylene blue solution (methylene blue group: n = 10), 5% (w/v) indigo carmine solution (indigo carmine group: n = 10) or 5% (v/v) fresh autologous erythrocyte suspension (autologous erythrocyte group: n = 10). At 4 weeks after injection, a small sterile opening was made in the peritoneal cavity of each rat. The cavity was rinsed once with TCM-199 to collect macrophages. The rinsed peritoneal contents were cultured overnight to evaluate macrophage activation. The peritoneal opening was expanded for evaluation of adhesion formation. Only one rat from the autologous erythrocyte group had intra-peritoneal adhesions (score 2), whereas all rats in the methylene blue group (score 1: n = 1; score 2: n = 4; score 3: n = 4; and score 4: n = 1) and seven rats in the indigo carmine group (score 1: n = 1; score 2: n = 2; score 3: n = 3; and score 4: n = 1) had intra-abdominal adhesions. Macrophage activity was observed in the cultured peritoneal contents collected from the methylene blue and indigo carmine groups but not from the autologous erythrocyte group. Adhesion formation could be due to macrophage activation caused by methylene blue and indigo carmine solutions. These results indicate that tubal patency can be observed by laparoscopy using autologous erythrocyte suspension. The results of this study are believed to be the first to indicate that a patient's own erythrocyte suspension could be used during observation of tubal patency by laparoscopy. However, further studies are required.

Thromboembolic complications prevention in the obstetric practice

2017 ◽  
pp. 19-24
Author(s):  
O.V. Grishchenko ◽  
◽  
V.V. Bobrytska ◽  
Keyword(s):  
Pulmonary Embolism ◽  
Comparison Group ◽  
Main Group ◽  
Control Group ◽  
Efficacy And Safety ◽  
Thromboembolic Complications ◽  
Moderate Risk ◽  
Obstetric Practice ◽  
Thrombotic Complications ◽  
And Control

The objective: To evaluate the clinical efficacy and safety of Enoxaparin-Pharmex for the prevention of thrombotic complications (pulmonary embolism) in the postoperative period in patients with moderate risk of these complications. Patients and methods. The study included 50 women after a caesarean section had an average degree of risk of pulmonary embolism. Patients were divided into the main group (n=25) and control group (n=25) in accordance with the treatment: patients of the main group received postoperative Еnoxaparin- Pharmex, group comparisons enoxaparin sodium (brand foreign manufacturer’s). Patients in both groups received the drug at a dose of 20 mg for 5 days, 1 time per day subcutaneously. Results. The research data analysis showed identity results of hemostasiogram of patients in the main group and the comparison group, no side effects after treatment in both groups. Conclusion. The clinical studies suggest the drug Enoxaparin-Pharmex is effective, safe LMWH, which can be used to prevent troboembolic complications, including post-operative treatment in obstetric practice. Spectrum of Enoxaparin-Pharmex can be extended to the prevention and treatment of thromboembolic conditions of varying severity with appropriate doses of the drug. Key words: Enoxaparin-Pharmex, prevention of pulmonary embolism.

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

scholarly journals Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

scholarly journals Development of a gel dedicated to gel immersion endoscopy

2021 ◽  
Vol 09 (06) ◽  
pp. E918-E924
Author(s):  
Tomonori Yano ◽  
Atsushi Ohata ◽  
Yuji Hiraki ◽  
Makoto Tanaka ◽  
Satoshi Shinozaki ◽  
...  
Keyword(s):  
Electrical Conductivity ◽  
Porcine Model ◽  
Ex Vivo ◽  
In Vitro Experiments ◽  
Efficacy And Safety ◽  
Coagulative Necrosis ◽  
Novel Technique ◽  
In Vivo Experiments

Abstract Backgrounds and study aims Gel immersion endoscopy is a novel technique to secure the visual field during endoscopy. The aim of this study was to develop a dedicated gel for this technique. Methods To identify appropriate viscoelasticity and electrical conductivity, various gels were examined. Based on these results, the dedicated gel “OPF-203” was developed. Efficacy and safety of OPF-203 were evaluated in a porcine model. Results  In vitro experiments showed that a viscosity of 230 to 1900 mPa·s, loss tangent (tanδ) ≤ 0.6, and hardness of 240 to 540 N/cm2 were suitable. Ex vivo experiments showed electrical conductivity ≤ 220 μS/cm is appropriate. In vivo experiments using gastrointestinal bleeding showed that OPF-203 provided clear visualization compared to water. After electrocoagulation of gastric mucosa in OPF-203, severe coagulative necrosis was not observed in the muscularis but limited to the mucosa. Conclusions OPF-203 is useful for gel immersion endoscopy.

Efficacy and safety of beta-blockers and prolonged bronchodilators in patients with heart failure with coronary artery disease and moderate to severe COPD

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Evdokimov ◽  
E Yushchuk ◽  
A Evdokimova ◽  
S Ivanova ◽  
I Sadulaeva
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Condition ◽  
Blood Pressure Monitoring ◽  
Beta Blockers ◽  
Control Group ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Severe Copd

Abstract Purpose To compare clinical efficacy and safety of various treatment regimens with the inclusion of beta-blockers, RAAS antagonists (ACE inhibitors or ARBs), prolonged bronchodilators (LABA, LAMA) in heart failure patients with CAD and COPD. Methods 385 patients (292 men and 93 women), aged 66.3±4.1 years, with CHF classes II to III (NYHA) combined with moderate to severe COPD (GOLD) and with LVEF less than 45% were randomized into nine groups: enalapril + LAMA (control group), nebivolol + enalapril + LAMA, nebivolol + losartan + LAMA, nebivolol + losartan + LABA, nebivolol + losartan + LAMA/LABA, carvedilol + enalapril + LAMA, carvedilol + losartan + LAMA, carvedilol + losartan + LABA, carvedilol + losartan + LAMA/LABA. Patients of all groups received complex CHF treatment comprising diuretics, nitrates, cardiac glycosides (if necessary). Clinical examination, TTE, 6-minute walk test (6MWT), 24-hour electrocardiogram and blood pressure monitoring, respiratory function test were assessed at baseline and after 6 months of treatment. The quality of life was evaluated by MYHFQ, SGRQ and mMRC scale. Results After 6 months of therapy the improvement of clinical condition and quality of life were marked in all groups. At the end of observation period there was a significant improvement of patients clinical condition, quality of life, reduction of mean CHF FC and dyspnea severity, increase of exercise tolerance, slowing of progression of CHF and COPD, improvement of the parameters of intracardiac hemodynamics, structural and functional parameters of the left and right heart (a decrease in the size of the atria, LV volumes and internal dimension at end-diastole and end-systole, cardiac index, LVMMI, an increase of LVEF, a significant decrease in systemic vascular resistance and the pulmonary hypertension grade, significant improvement in systolic and diastolic function of the ventricles, regression of pathological remodeling of the heart, reduction of heart rate, duration and frequency of myocardial ischemia episodes (including its “silent” form). The best results were obtained in groups using a beta-blocker (nebivolol or carvedilol), a RAAS antagonist, and a combination of long-acting bronchodilators (indacaterol and tiotropium) – group 5 and 9. It is worth noting that beta-blockers, LABA and LAMA were well tolerated in all observation groups and serious adverse events were absent. Conclusions The appointment of 3-generation beta-blockers to patients with CHF on the background of CAD and COPD can significantly increase the effectiveness of treatment and does not cause a deterioration in spirometry in patients with such cardiopulmonary pathology. In our opinion, the most important point in the appointment of beta blockers to patients with moderate to severe COPD is low start dose and slow titration of the dose at the beginning of the therapy. It is advisable to include in the complex therapy of such patients a combination of LABA and LAMA as a basic bronchodilator support. Funding Acknowledgement Type of funding source: None

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

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