PREDICTIVE FACTORS OF THE OUTCOME OF EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY FOR UPPER TRACT UROLITHIASIS

Extracorporeal Shock Wave Lithotripsy (ESWL) is one of the treatment options for renal and upper ureteric calculus; however, the outcome depends on multiple factors. Our study aims to evaluate the factors that may inuence ESWL outcomes in Indian patients with upper urinary tract calculi. Between 2018 and 2020, a total of 300 adult patients who underwent ESWL for renal and upper ureteral calculus sizing 5 to 20 mm were included in the study program. Patients with

Alteration in Serum Lipid Profile Pattern in Oral Squamous Cell Carcinoma and Potentially Malignant Disorders

ABSTRACT Objective: To evaluate and compare lipid profile level in oral submucous fibrosis (OSMF), oral leukoplakia (OL) and oral squamous cell carcinoma (OSCC) patients. Material and Methods: Thirty histopathologically diagnosed subjects each of OL, OSMF, OSCC were recruited along with 30 healthy controls. 5ml of venous blood is collected and estimated using standard diagnostic kits. Results: The mean of Total cholesterol level in controls was 219.03 mg%, in OSCC, OL and OSMF was 142.89 ± 10.21mg%, 155.44 ± 17.63 mg% and 180.60 ± 13.25 mg%, respectively. The mean low-density lipid level in controls was 137.24 mg and in OSCC, OL and OSMF groups were 109.28 ± 2.16 mg%, 126.63 ± 0.85 mg% and 119.15 ± 0.93 mg%, respectively. The mean of high-density lipid level in controls, OSCC, OL and OSMF was 42.87 ± 0.42 mg%, 36.50 ± 2.31 mg%, 21.13 ± 0.77 mg% and 28.37 ± 1.11mg%, respectively. The mean of very low density lipids level in controls, OSCC, OL and OSMF was 30.12 ± 1.51 mg%, 17.24 ± 0.80 mg%, 22.25 ± 0.93 mg% and 25.89 ± 0.43 mg%, respectively. The mean triglyceride level in controls, OSCC, OL and OSMF was 118.80 ± 9.47 mg%, 91.2 ± 3.03 mg%, 105.05 ± 2.96 mg% and 106.19 ± 3.09 mg%, respectively. Conclusion: Lipid profile levels could be early indicators of precancer and cancer.

Correlation of estimated glomerular filtration rate with ejection fraction among type 2 diabetes mellitus patients: results of a cross sectional study from Southern India

Background: There is paucity of data regarding the relationship between the severity of left ventricular dysfunction and renal function impairment in diabetic patients. Aims and objectives was to study the relation between eGFR and ejection fraction in type 2 diabetes mellitus of more than 5 years duration.Methods: This cross sectional was carried out from May 2017 to May 2018 at Yenepoya Medical college a tertiary care center in the southern Indian state of Karnataka. The data on 220 diabetic patients were studied. A detailed clinical history physical examination was carried out on the study population as per the approved proforma. Apart from base line investigations, eGFR was calculated using serum creatinine levels. 2D echocardiography was done for the assessment of ventricular function.Results: Out of 220 patients, 138 were men (63%) and 82 were women (37%) and the mean age of the patients was 59.60±11.145 years. The mean duration of diabetes was 10.08±5.28 years. We found a progressive reduction in ejection fraction from 57.74±9.97% to 50.64±14.7 as the eGFR declined from <90 mL/min/1.73m2 to 30 mL/min/1.73m2. There was significant correlation between eGFR and RWMA (p value 0.001) and LVDD (p value 0.029) in this study cohort. Micro/macroalbuminuria was found to be in 55% of patients. Proteinuria had significant correlation with longer duration of diabetes, blood urea, serum creatinine and eGFR.Conclusions: This study found positive clinical correlation between LVEF and eGFR. However, it did not reach significant levels statistically. Further studies may be carried out to confirm the association.

Clinical Consequences of Untreated Dental Caries among Primary School Children: A Cross-Sectional Study

Abstract Objective: To evaluate the dental caries experience and clinical consequences of untreated dental caries (UDC) among primary school children of Al Jouf region, Saudi Arabia and to determine the correlation between dental caries experience and clinical consequences of UDC. Material and Methods: A 250 primary school children 6-7 years were recruited using systematic random sampling. The prevalence of dental caries in deciduous dentition was assessed by following WHO criteria using the dmft index and the clinical consequence of UDC was assessed with the pufa index. The pufa score was calculated cumulatively following the pufa diagnostic criteria. The Student's t-test was used to equate the mean dmft and pufa scores between boys and girls. The correlation between the dmft and the pufa scores was evaluated using Pearson's correlation coefficient (r), and the p-value was set at 0.05 for statistical significance. Results: Out of which 154 (61.60%) boys and 94 (37.60%) were girls. The mean (SD) values of dmft for boys reported to be 5.37 (± 3.31) and for girls 6.35 (± 3.27), which was statistically significant with gender (p<0.001). Statistically, significant mean values of pufa were 1.20 (± 1.37) in boys and 1.71 (± 1.58) in girls, respectively was observed (p<0.001). The Pearson correlation between dmft and pufa values showed a highly significant positive correlation among dmft and pufa values (r= 0.635, p<0.001). Conclusion: The present study revealed that high caries prevalence and experience of the clinical consequences of UDC in the primary dentition, and there was a strong positive correlation between dmft and pufa score values.

Accuracy of Cone Beam Computed Tomography in the Assessment of Mandibular Molar Furcation Defects

Abstract Objective: To evaluate the accuracy of cone-beam computed tomography (CBCT) in the assessment of mandibular molar furcation defects. Material and Methods: Thirty patients with furcation defects were selected, oral hygiene instructions, scaling, and root planing with ultrasonic devices and hand instruments and occlusal adjustments were performed. Pre-surgical clinical measurements were carried out at the buccal aspect of the selected mandibular molars. The horizontal furcation measurements were measured with a Nabers Probe starting at the furcation entrance to the greatest horizontal depth. The degree of furcation involvement was graded from 0 to III. Bone loss in the horizontal and vertical direction and the width of the furcation entrance were measured on CBCT and after reflecting the full-thickness flap and debridement of the defects. The data were analyzed using t-test and Pearson's correlation coefficient. Results: The width of furcation entrance in clinical method was 3.27 ± 0.77, while in CBCT method was 3.35 ± 0.71, clinically the vertical bone loss was 3.61±1.09, while in CBCT was 3.57 ± 1.15, horizontal bone loss in clinical method was 5.08 ± 2.21, while in CBCT was 5.11 ± 2.23. No significant difference between the two methods was noted, and a high correlation between the two methods was observed. With regards to the agreement between the two methods of assessment, the width of furcation entrance revealed a difference between the two methods by 0.08 ± 0.21, while vertical bone loss showed difference between the two methods by -0.04 ± 0.19, the horizontal bone loss showed a mean difference between the two methods by 0.03 ± 0.21. Conclusion: CBCT provided high accuracy for the furcation involvement detection and anatomy of surrounding periodontal tissues.

Assessment of Caries Spectrum of First Permanent Molars in 7- to 8-Year-Old School Children in Northern Saudi Arabia: A Cross-Sectional Study

Abstract Objective: To estimate caries spectrum in first permanent molars (FPMs) of 7- to 8-year-old children in Saudi Arabia using Caries Assessment Spectrum and Treatment (CAST) index, and examine the correlation between distributions of CAST codes among contralateral and opposite arches. Material and Methods: A cross-sectional survey was conducted of 7- to 8-year-old Saudi school children in Sakaka, Aljouf, Saudi Arabia. A total of 385 children were examined. CAST codes were determined for FPMs, and their distribution was analyzed using Spearman's rank correlation coefficient. Statistical significance was set as p<0.05. Intra-examiner reliability was determined using the unweighted kappa coefficient. Results: The results indicated most of the FPMs were scored as code 3 (enamel lesions) such as upper contralateral FPM 44.40% for right, 53.50% for left, respectively, and lower contralateral molars were 61.30% for right and 64.90% for left, respectively. It was also observed that upper FPMs had scored code 0 (sound teeth) more than that of lower FPMs. Serious morbidity (codes 6 and 7) and mortality (code 8) showed a low prevalence in FPMs. Strong correlations were observed between upper contralateral FPMs (r=0.586) and lower contralateral FPMs (r=0.567, p<0.001). Conclusion: A high prevalence of enamel caries lesions (code 3) was observed in FPMs; in addition, a strong correlation was present between upper contralateral FPMs and between lower contralateral FPMs.

Frequency and Characteristics of Mesiodens in Indian School Children: A Retrospective Radiographic Study

Abstract Objective: To determine the frequency and characteristics of mesiodens in Indian school children. Material and Methods: 1232 radiographs of patients attending the Department of Oral Medicine and Radiology of the age group of 4-15 years studied for the present retrospective study. The intraoral periapical radiographs and occlusal radiographs of the premaxilla were examined to determine the presence of mesiodens. The data regarding the presence of mesiodens, number, position, location on the arch, shape and associated complications were recorded. Results: Eleven patients had 14 mesiodens, with a frequency of 0.8%. The ratio of boys to girls was 1.2:1. Maximum mesiodens observed in the age group of 7-9 years. Most of the mesiodens were conical in shape and found on the palatal side. Fifty percent of the mesiodens were unerupted. The majority of patients (57.1%) had vertically positioned mesiodens. Midline diastema was the most common complication due to mesiodens (66.7%). Conclusion: Routine check-up during the primary dentition and mixed dentition stages helps for early detection of mesiodens and thus preventing complications. Early identification is useful for planning comprehensive management, initiating proper consultation and referral for evaluation and treatment.

Oral Health-Related Quality of Life (OHRQoL) in Patients with Dental Prosthesis

Abstract Objective: To determine the Oral Health-Related Quality of Life (OHRQoL) for post-treated fixed dental prostheses in selected sample of patients. Material and Methods: 120 patients treated with fixed dental prostheses, either single crowns or fixed partial dentures in maxillary or mandibular arches were asked to express their views about their quality of life. Patients' files were randomly selected from the archives of Department of Prosthetic Dental Sciences, College of Dentistry, Jouf University, Saudi Arabia. For this purpose, a self-structured questionnaire was prepared and their responses recorded. The responses were categorized on a 5 point scale and frequencies calculated. Results: Of 120 patients approached, 79 responded with the mean age group of 37 years. From the survey, it was noted that only three variables were statistically significant, those relating to the importance of natural teeth over fixed prostheses (p=0.046), the ability to chew all kinds of foods (p=0.021) and satisfaction with the occlusion (p<0.001). Conclusion: Oral health remains important, which directly or indirectly is related to many systemic diseases. In the present study, the majority of patients were satisfied with the treatment given.

Prevalence of hypercementosis in a saudi arabian population: a cone beam computed tomography study

Objective: to determine the prevalence of hypercementosis in a Saudi Arabian population. material and methods: a total of 642 CBCT scans from patients comprising 4471 teeth were incorporated in the study sample. all teeth were analyzed for the presence of hypercementosis in sagittal, axial and coronal plains by two qualified and experienced observers. the characteristics of the involved tooth in terms of gender, jaw and location were recorded from the CBCT scans. the obtained data were statistically analyzed using SPSS 21.0. the reliability of measurements was evaluated by kappa statistics. results: out of total 642 subjects hypercementosis was observed in 31 patients (4.82 percent) and 43 teeth (0.96 percent). Eight (2.68 percent) maxillary 1st molars, 6 (1.88 percent) mandibular 1st molars, 5 (1.46 percent) maxillary second molars, 7 (1.95 percent) mandibular 2nd molars, 9 (4.76 percent) maxillary 3rd molars and 8 (3.58 percent) mandibular 3rd molars were observed to have hypercementosis. among males, 4.76 percent were affected with hypercementosis as compared to 4.86 percent of females (p=0.97). likewise, no significant difference in the occurrence of hypercementosis was observed between maxillary and mandibular arches or between sides (p>0.05). conclusion: the prevalence of hypercementosis in a Saudi population was found to be 4.82 percent with respect to patients and 0.96 percent with respect to teeth. No significant propensity for gender, jaw and arch side was noted.

Three-Rooted Mandibular First Molars in a Saudi Arabian Population: A CBCT Study

Objective: To know the prevalence three-rooted mandibular first molars in a Saudi Arabian population by using CBCT. Material and Methods: A total of 428 CBCT scans in the database of the College of Dentistry, Jouf University, Kingdom of Saudi Arabia were analyzed. All well-developed permanent mandibular first molars were analyzed for the presence of extra root in three dimensions and the reconstructed volumetric images by two qualified and experienced observers. The total incidence, distribution and comparison regarding gender, bilateral and unilateral appearance, and the side of occurrences of these permanent three-rooted mandibular first molars were analyzed by the Chi-square test. The level of significance was set at 5%. Results: The CBCT scans of 14 subjects had three rooted mandibular first molars with a prevalence of 3.27%. The prevalence in males and females was 2.96% respectively, with no significant differences between genders (p=0.865). The frequency of bilateral three-rooted mandibular first molars was 1.16%, with unilateral frequencies of 1.40% and 0.70% on the right and left sides, respectively. No significant relationship between sides (p=0.981) and the bilateral prevalence of three-rooted mandibular first molars (p=0.668) was observed. Conclusion: Dental practitioners must be aware of the fact that though it is rare, an extra or third root can be present in mandibular first molars and CBCT can aid in accurate diagnosis of the presence of third root.

Comparative Evaluation of Antimicrobial Efficacy of Silver, Titanium Dioxide and Zinc Oxide Nanoparticles against Streptococcus mutans

Objective: To determine the antimicrobial efficacy of silver, titanium dioxide and zinc oxide nanoparticles against Streptococcus mutans. Material and Methods: Serial dilution method was employed for preparing 1%, 0.5%, 0.25% concentrations of the three test compounds. ATCC 25175 strain of streptococcus mutans was used to assess the antimicrobial activity of test compounds. Equal quantity of BHI broth was dispensed in test tubes containing sectioned tooth and to this the prepared bacterial inoculum was added. Prepared concentrations of test compounds were added accordingly and incubated for 24hrs at 370C. Then, the sectioned tooth was removed and the adherent bacteria were transferred into saline solution by vortexing. These suspensions were transferred onto sterile blood agar plate to make lawn culture and were further incubated at 370C for 24hrs to determine viable bacterial count. The number of colonies were counted manually from each plate and recorded for further analysis. Decrease in number of colonies represents the effective concentration of the test compound against the inhibition of biofilm formation. Results: A significant difference in the colony forming units among all three concentrations of silver (Ag), titanium dioxide (TiO2) and zinc (ZnO) nanoparticles was noted and the antimicrobial effect of nanoparticles was concentration dependent. Inter group comparison of colony forming units with 1%, 0.5% and 0.25% of the test compound revealed that the colony forming units on the ZnO nanoparticles demonstrated highest value followed by TiO2 and the least were with that of the Ag nano particles. Conclusion: Silver, Zinc oxide and Titanium dioxide showed significant antimicrobial effects and the antimicrobial effect of nanoparticles was concentration dependent.

A Cone Beam Computed Tomography Study of the Prevalence of Pulp Stones in a Saudi Arabian Adolescent Population

Objective: To assess the prevalence of pulp stones using Cone Beam Computed Tomography (CBCT) in a Saudi Arabian adolescent population. Material and Methods: CBCT scans of 237 individuals compromising of 1018 teeth were examined. All teeth were analyzed in three dimensions and the presence of pulp stones were identified as a round or oval shaped dense structures in the pulp space. The location of involved tooth in terms of arch, side involved and the status of the tooth were documented. Statistical analysis was carried out by applying Chi-square test. The level of significance was set at 5%. Results: Pulp stones were observed in 119 out of the 237 participants, and in 118 teeth out of 1018 teeth examined, with the patient prevalence of 50.2% and tooth prevalence 10.6%. Pulp stones were observed in 76 (51.3%) of males and 43 (48.3%) of females, with no significant difference (p>0.05). A nonsignificant difference was also noted when maxillary and mandibular arches and the left and right sides were compared. Pulp stones were observed more frequently observed in molars and in carious (8.8%) and restored teeth (17.1%). Conclusion: The prevalence of pulp stones was high in molars and in carious and restored teeth. No significant difference was noticed between gender, arch and side of tooth involved with pulp stones.

Comparative Study of the Efficacy of Newer Antioxitands Lycopene and Oxitard in the Treatment of Oral Submucous Fibrosis

Objective: To compare the efficacy of oxitard and lycopene in the management of Oral Submucous Fibrosis (OSMF). Material and Methods: 120 subjects with clinicpathologically diagnosed OSMF were included in the study and divided equally in 2 groups, Group A (oxitard) and Group B (lycopene). Group A was administered 2 oxitard capsules twice daily and Group B was given 8 mg lycopene in 2 divided doses of 4 mg for 3 months. Gingival index and plaque index were documented for all patients and compared. Evaluation for different clinical parameters was done at regular intervals and data was analyzed using the Student's paired t test and Chi-square test. P-value <0.001 was considered to be statistically significant. Results: Clinical improvements in mouth opening and tongue protrusion was significant in Group A (p<0.001). Subjective symptoms of pain associated with the lesion (p=0.0001), difficulty in swallowing (p=0.0004) and speech (p=0.0002) significantly improved in the Group A. However, there was no significant improvement in burning sensation (p>0.001) among the 2 groups. Although the mean gingival index and plaque index in group A was reduced but it was found to be not statistically significant. Conclusion: Oxitard capsules can bring about significant clinical improvements in the symptoms like mouth opening, tongue protrusion, difficulty in swallowing and speech and pain associated with the lesion when compared to lycopene, thereby improving the quality of life of the affected individuals.

A Radiographic Study of Prevalence and Location of Enamel Pearls in a Saudi Arabian Adolescent Population

Objective: To determine the prevalence of enamel pearls on panoramic radiographs and to explore any potential correlation between the occurrences of enamel pearls with gender, jaw and tooth involved. Material and Methods: Digital panoramic radiographs of 642 adolescents aging 12­19 years were examined for the presence of enamel pearls. The location of involved tooth in terms of jaw and side and gender were recorded. Statistical analysis was carried out by applying Chi-square tests with the Yates correction. The level of significance was set at 5%. Results: The person prevalence of enamel pearls was 4.82% of patients and tooth prevalence was 0.96%. No statistical significant difference was observed between maxillary and mandibular arches and no gender and side predilection was observed. Most of the enamel pearls were seen in maxillary third molars (4.76%) and mandibular third molars (2.68%), followed by maxillary first molars (2.68%) and mandibular second molars (1.95%). No enamel pearl was observed in any of the anterior teeth or in any of the deciduous teeth. Conclusion: The prevalence of enamel pearls was observed in 4.28% of patients and 0.96% of teeth. They were most frequently seen on molars with no predilection for gender, jaw and side.

Establishing institutional ethics committees: challenges and solutions–a review of the literature.

This review of the literature was conducted to identify the challenges faced while establishing institutional ethics committees (IECs) as well as to suggest some solutions. The search of the literature was carried out with the help of the PubMed search engine, using “research ethics committees” (MeSH] and “India” (MeSH]) as the key words for articles published between 2004 and 2012. We found 31 articles related to the topic, and the most common challenge mentioned was inappropriate functioning of IECs (n=17), followed by inappropriate structure (n=14).

Ocular Hypotensive Effect of Topical Verapamil and Diltiazem in Steroid Induced Glaucoma Model of Rabbits.

Objectives: To evaluate possible ocular hypotensive effect of 0.5% diltiazem and 0.1% verapamil eye drops on intraocular pressure in steroid induced glaucoma model of rabbits. And compare with 0.5% timolol eye drops. Methodology: Glaucoma was induced in rabbits (N=18) by bilateral topical instillation of 1% prednisolone eye drop (10 μl) twice a day for a period of 40 days. Before the induction of glaucoma, baseline intraocular pressure (IOP) in both the eyes of all rabbits was measured under sedation (i.v midazolam) by Schiotz tonometer. At the end of 40 days induced IOP was measured for all rabbits and rabbits were divided into three groups of six rabbits in each. Right eyes of group A, B and C rabbits received 0.5% diltiazem, 0.1% verapamil, and 0.5% timolol eye drops twice daily for 12 days respectively. Whereas, left eyes of all rabbits received distilled water hence represented as control. IOP was measured in all rabbits on every 4th day till 12 days of treatment period. Results: Intra-group comparisons of IOP changes were made by paired‘t’ test. And unpaired‘t’ test for inter group comparisons. One way ANOVA was used for multiple group comparisons followed by post-hoc Tukey’s test for group wise comparisons. In 0.5% diltiazem treated eyes, the mean IOP significantly reduced from 22.9±1.9 mmHg (10%) on 4th day to 16.9±1.1 mmHg(S, P<.001) on 12th day (34%). Similarly, mean IOP in 0.1% verapamil treated eyes significantly reduced from 22.7±1.3 mmHg (7%) on 4th day to 15.5±1.4 mmHg(S, P<.001) on 12th day (37%). Whereas, mean IOP significantly reduced from 22.4±1.9 mmHg (14%) on 4th day to 16.4±1.4 mmHg (S, P=.001) on 12th day (36%) in 0.5% timolol treated eyes. Conclusion: Topical 0.5% diltiazem and 0.1% verapamil significantly reduced the IOP in steroid induced glaucoma model of rabbits. However, Further research has to be carried out both in experimental and clinical subjects to reveal its efficacy and safety profile.

Correlation between difficulty & discrimination indices of MCQs in formative exam in Physiology.

Introduction: Difficulty index (P) and discrimination index (D) are the parameters used to evaluate the standard of multiple choice questions (MCQs) in examination. Accordingly the standard of MCQs can be interpreted as excellent, acceptable or poor. This study was intended to find out the standard of MCQs in formative examination in Physiology. The study also intended to find out correlation between P and D. Materials and Methods: There were 240 MCQ items, taken from the past 4 year batches of 100 students and were analyzed for level of difficulty and discrimination index. The relationship between them for each test item was determined by Pearson correlation analysis using SPSS 11.5. Results: There was a wide distribution of item difficulty indices (8.57 to 95.71) and discrimination indices (-0.54 to 0.8).The mean difficulty index (P) was 52.53 + 20.59 and mean discrimination index was 0.30+ 0.18. On average, about 23% of the MCQ items were easy (P >70%), while about 15% were difficult (P <30%). The remaining 62% items were within acceptable range (30 to 70%). In all 4% of the items showed negative discrimination and 21% of the items exhibited poor discrimination. The remaining 75% of the items were in the range of acceptable to excellent discrimination. The discrimination index exhibited slight positive correlation with difficulty index (r = 0.191, P=0.003<0.01). The maximal discrimination (D=0.6-0.8) was observed with moderately easy/difficult items (P = 40% - 60%). Conclusion: The majority (75%) of the items was acceptable as far as difficulty and discriminative indices were concerned. Moderately easy/difficult items had maximal discriminative ability. Too easy and too difficult items gave poor discrimination index. Negative discrimination was observed in only 4% of the items indicating faulty items or incorrect keys.

Assessment of cardiovascular response to treadmill exercise in normal healthy Indian adolescents.

The study aims to assess the cardiovascular response to treadmill exercise test in healthy Indian adolescents. A group of 50 healthy adolescents took part in the study. Cardiovascular response was assessed by using treadmill exercise test as per Bruce protocol. Pulse rate, blood pressure and ECG were recorded before, during and after undertaking the treadmill test. Mean age and body mass index (BMI) were 18.7±0.51 yrs. and 21.4±3.44 kg/m2 respectively. Karl Pearson Correlation analysis showed highly significant negative correlation between BMI and exercise time (r = –0.598, P<0.001) and between resting DBP and Exercise Time (r = –0.424, P<0.002). While BMI and DBP showed highly significant positive correlation (r = 0.463, P<0.001). During exercise pulse and SBP rose and DBP fell. SBP rose from mean 122 to 175 (rise by 53 mm of Hg) and DBP fell from mean 78 to 65 (fall by 13 mm of Hg). One min recovery pulse was 156 indicating 22% fall from target heart rate. All the parameters returned to near resting value at 6 min recovery. In 30% students DBP showed exaggerated response i.e. rise during exercise. These students had more BMI and higher resting DBP as compared to other students, which could be the reason for exaggerated response in these participants. In ECG there were no significant ST/T changes during exercise or recovery period. This study provides normal data for small sample of healthy Indian adolescents when subjected to treadmill exercise test.

Survey of ethics committee protocol approval letters: compliance with Schedule Y / ICMR Guidelines 2006; Schedule Y requirements.

A study was carried out to determine the extent to which ECs comply with format requirements given in guidelines and regulations. ECs were sent a written communication requesting them to permit investigators to study their approval letter for compliance with the ICMR Guidelines and Schedule Y, using a predesigned proforma. Of the 60 ECs approached, only 20 agreed to participate. Legal experts and social scientists were not present at the approval meetings of most of the ECs. Only 7 ECs had a quorum according to Schedule Y. Several ECs did not state whether documents such as the clinical trial agreement and insurance policy were reviewed. Delays in sending approval letters could be shortened with efficacious operating of ECs. There is a need to train EC members and create a better awareness of regulatory requirements. There is also a need to evolve a mechanism to monitor EC functioning.