International Journal of

Pharmaceutical and Clinical Research

e-ISSN: 0975 1556

p-ISSN 2820-2643

Peer Review Journal

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1. Spectrophotometeric Determination of Trifluoperazine HCL in Pure Forms and Pharmaceutical Preperations
Mohammad J Hamzah, Rawa M M Taqi, Muna M Hasan, Raid J M Al-Timimi
A simple and accurate spectrophotometric method for the determination of Trifluoperazine HCl in pure and dosage forms was developed. The method is based on the reaction between Trifluoperazine HCl and p-chloroaniline in the presence of cerium ion as oxidizing agent which lead to the formation of violate color product that absorbed at  a maximum wavelength 570nm while the blank solution was pink. Under the optimum conditions  a linear relationship between the intensity and concentration of TRF in the range 4-50μg/ml was obtained . The molar absorptivity 3.74×103 , Limit of detection (2.21μg/ml), while limit of quantification was 7.39μg/ml. The proposed analytical method was compared with standard method using t-test and F-test , the obtained results shows there is no significant differences between proposed method and standard method. Based on that the proposed method can be used as an alternative method for the determination of TRF in pure and dosage forms.

doi number =10.25258/ijpcr.v9i7.8593

2. A Study of Sleep Disorders in Patients with Chronic Kidney Disease (CKD)
Hussein A, ElHadidy A, Gomaa N, Amin Y, El-Shabouny T
Sleep apnea is an important comorbidity in patients with chronic kidney disease (CKD). Although the increased prevalence of sleep apnea in patients with CKD is well established, few studies have examined the full spectrum of kidney function. We sought to determine the prevalence of sleep apnea and associated nocturnal hypoxia in patients with CKD. We hypothesized that the prevalence of sleep apnea would increase progressively as kidney function declines. 45 patients were recruited from outpatient nephrology clinics, nephrology department, and hemodialysis units. All patients completed an overnight inpatient polysomnograhy test to determine the prevalence of sleep apnea (AHI ≥ 5 events /h) and nocturnal hypoxia (oxygen saturation (SaO2) below 90% for ≥12% of the nocturnal monitoring time). Patients were stratified according to their estimated glomerular filtration rate (eGFR) at the time of the study visit into three groups as follows: CKD stage 2 (eGFR 60 to 89 mL/min/1.73 m2) (control group), CKD stages 3 and 4 (eGFR 15 to 59 mL/min/1.73 m2), and CKD stage 5 (eGFR <15 mL/min/1.73 m2). eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Out of the 45 patients included in our study with the full spectrum of kidney function, ranging from those with eGFR 60 to 89 ml/min./1.73m2 to patients with eGFR <15 ml/min./1.73m2, 15 (33.3%) had sleep apnea (Mean AHI; 8.71±5.86). Our study found that prevalence of sleep apnea increased as kidney function declined (Group (I), 20%; Group (II), 36.4%; Group (III), 37.5%). Furthermore, severity of sleep apnea increased as kidney function declined (Group (I), mean AHI: 5.75±0.35; Group (II), mean AHI: 6±1.38; Group (III), mean AHI: 10.6±7.04). We also found that prevalence of nocturnal hypoxia which is characteristically associated with sleep apnea was greater among groups (II) and (III) (27.3% and 16.7%, respectively) than in group (I) (10%). Severity of nocturnal hypoxia increased as kidney function declined (Group (I), 13%; Group (II), 13.6±1.22%; Group (III), 16.75±3.30%). Overall, 8 out of the 45 studied CKD patients (17.8%) had nocturnal hypoxia (Mean SaO2 below 90% for ≥12% of the nocturnal monitoring time; 15.1±2.87%). Our study revealed that as kidney function declined, Apnea/Hypopnea (AHI) indices increased, oxygen desaturation indices increased, minimal peripheral capillary oxygen saturation values decreased, peripheral capillary oxygen saturation time <90% increased, and snore indices increased. Also, respiratory distress index (RDI) was higher among groups (II) and (III) than in group (I). However, only differences between groups as regards respiratory distress events, respiratory distress indices, snore events, and snore indices were statistically significant. These results show that as kidney function declines, several respiratory parameters deteriorate during sleep. In addition, wake events and indices, and sleep stage 1 (%) increased as kidney function deteriorated. Sleep efficiency (%) was highest among group (I) patients and lower among groups (II) and (III), Light sleep (%) was lowest among group (I) patients and higher among groups (II) and (III), and deep sleep (%) was highest among group (I) patients and lower among groups (II) and (III). It is clear from the above results that as kidney function declines, sleep efficiency deteriorates, wake indices increase, light sleep (%) increases, and deep sleep (%) decreases. We concluded that prevalence and severity of sleep apnea in patients with CKD increase as kidney function declines. Almost 18% of patients with CKD experience nocturnal hypoxia, which may contribute to loss of kidney function.

doi number =10.25258/ijpcr.v9i7.8594

3. Role of 4-O Galloylchlorogenic Acid in Lung Cancer- An Insilico Approach
Jaynthy C, N Premjanu, Abhinav Srivastava
Cancer is a major disease with millions of patients diagnosed each year with high mortality around the world. Various studies are still going on to study the further mechanisms and pathways of the cancer cell proliferation. Fucosylation is one of the most important oligosaccharide modifications involved in cancer and inflammation. In cancer development increased core fucosylation by FUT8 play an important role in cell proliferation. Down regulation of FUT8 expression may help cure lung cancer. Therefore the computational study based on the down regulation mechanism of FUT8 was mechanised. Sapota fruit extract, containing 4-Ogalloylchlorogenic acid was used as the inhibitor against FUT-8 as target and docking was performed using in-silico tool, Accelrys Discovery Studio. There were several conformations of the docked result, and conformation 1 showed 80% dock score between the ligand and the target. Further the amino acids of the inhibitor involved in docking were studied using another tool, Ligplot. Thus, in-silico analysis based on drug designing parameters shows that the fruit extract can be studied further using in-vitro techniques to know its pharmacokinetics.

doi number =10.25258/ijpcr.v9i7.8595

4. A Cross Sectional Study to Assess Liver Fibrosis in Patients with Diabetes and Metabolic Syndrome
Syed Safiullah Ghori, Hafsa Khalid, Mohammed Alim, Mohammed Abdul Quddus
The present study was conducted in Osmania General Hospital,Hyderabad.The study included evaluation of  liver fibrosis in patients with diabetes and metabolic syndrome. Liver fibrosis is now being considered as reversible process which is characterized by excessive accumulation of extra cellular matrix. The use of non-invasive methods to assess liver fibrosis in patients with HCV, Non-Alcoholic Fatty Liver Disease (NAFLD) and alcohol abuse has been well validated. However use of these non-invasive methods in patients with diabetes mellitus and metabolic syndrome assessed might develop fibrosis during asymptomatic stages. Hence we tried to use these non-invasive methods in patients with diabetics and metabolic syndrome who are at high risk of developing NAFLD or liver fibrosis in routine clinical practice. This was a single center, prospective study. 50 patients with diabetes and metabolic syndrome attending the endocrinology department of Osmania General Hospital were assessed for fatty liver and enrolled in to the study. NAFLD fibrosis score was used to assess liver fibrosis and BARD score was used for staging of fibrosis as per metavir classificationThe mean age of the patients was 50.8 ± 8.2 with 22 males and 28 females. 90% of the population was found to have some degree of fibrosis. 56% of the patients were at advance fibrosis stage as per the BARD score.Patients with diabetes and metabolic syndrome should be constantly evaluated for liver fibrosis apart from development of diabetes and other complications and to prevent any adverse effects due to waning of liver functions.

doi number =10.25258/ijpcr.v9i7.8596

5. Treatment and Management of Nocturnal Enuresis: A Review
Kandula Ravindra Reddy, Ramam Sripada
Nocturnal Enuresis (NE) is the involuntary passing of urine whileasleep after the age at which bladder control would normally be prevised. NE has hassled humans for hundreds of years. It has been recognized since the time of Papyrus Ebers, 1550 B.C. Various potions were prepared by using different plants, animals or organs in some of the early treatment modalities. A number of medications have been used to treat nocturnal enuresis where, Imipramine and Desmopressin acetate were found to be efficacious. Besides, some credit has also been given to Oxybutynin. Because of the high relapse rates recited after short-term therapy with pharmacotherapeutic agents, pharmacological treatment for NE is best considered as management therapy rather than a cure. In this review article, we have mainly focused on the treatment and management of nocturnal enuresis by reviewing various treatment modalities along with behavioural modifications, bladder retention training, hypnotherapy, psychotherapy and combination therapy.

doi number =10.25258/ijpcr.v9i7.8597

6. Is There a Correlation Between the Clinical, Radiological and Ultra-Sonographic Findings of Osteoarthritis of the Knee?
Anousheh Haghighi, Nahid Dehghani Arani, Nahid Kianmehr, Mani Mofidi, Mahgol Farjadnia, Elham Rajae, Mehrdad Dargahi MalAmir
Objectives: The association between the severity of knee pain and the clinical and radiological findings can help to assess the severity of knee osteoarthritis. The present study aimed to assess the relationship between knee pain severity and clinical, radiological and ultra-sonographic findings in patients with knee osteoarthritis. Methods: We recruited 52 patients with primary osteoarthritis. Physical examination and ultrasonography were done. Plain radiography was done within 3 weeks of clinical examination. Results: The average age of participants was 59.27 ± 9.85 years. Using multivariable linear regression modeling, pain severity had no significant association with any of the covariates including epidemiological, clinical and ultrasound findings. The severity of clinical symptoms and stiffness was associated with the ultrasound finding of Baker’s cyst as well as with tenderness of internal compartment and suprapatellar effusion. In addition, the level of daily function remained to be associated with baker’s cyst in ultrasound assessment as well as with tenderness of internal compartment. Conclusion: Our study showed no association between ultra-sonographic, clinical or radiological findings and the level of knee pain; however, knee function, disability, and the level of quality of life are associated with some clinical and ultrasound evidences of knee osteoarthritis.

doi number =10.25258/ijpcr.v9i7.8598

7. Estimation of Trace Elements in Gingival Crevicular Fluid and Serum-Comparative Study in Healthy and Periodontitis
BhagavathamMeenakshi, Chitraa R Chandran, AravindhanThathchariRanganathan, KavindapadiVenkateswaran Rama, ValarmathySrinivasan
Background: This study aims to determine and compare the levels of trace elements copper, zinc, selenium and chromium in GCF and serum of patients with periodontitis and healthy individuals. Methods: This  cross sectional study includes 24 study subjects recruited from the patients reporting to the Department  of Periodontics , Tagore  Dental College Chennai. All the selected patients were subjected to a clinical examination done by a single examiner.  The estimation of trace elements Copper, Zinc, Selenium and Chromium in GCF and serum is performed using Perkin Elmer optima 5300 Inductively Coupled Plasma Emission Spectrometer (ICPOES). Results: GCF and serum copper levels showed no significant difference in both periodontitis and  healthy groups . Selenium levels tend to be the same in both groups. Serum zinc levels are more in periodontitis patients than healthy subjects (p<0.01). GCF chromium levels are found to be more in patients with periodontitis than healthy. Conclusions : More research is therefore needed to monitor the role of these trace elements C with an increased sample size to ascertain whether they are associated with a reduced risk of periodontitis.

doi number =10.25258/ijpcr.v9i7.8599

8. A Novel Binary Biofilm Coinfection Model for the Simultaneous Growth of Gram-Positive and Gram-Negative Bacterial Species
Ibrahim S I Al-Adham, Sehar Wani, Elham Al-Kaissi, Phillip J Collier
Objectives: The aim of this study was to determine if it is possible to establish and maintain a binary biofilm consisting of Gram-positive (Bacillus subtilis) and Gram-negative (Escherichia coli) bacteria, which could be used as a multi-species model for antibiotic action studies. Materials and Methods: A medium controlled, continuous culture biofilm model was developed based upon the previously developed Sorbarod™ model. This new model was designed to enable the growth of B. subtilis and E. coli at the same time without either out-competing the other. Results: A pseudo-steady-state binary biofilm was established, which could be maintained for a total of 53 hours. This biofilm was tested to confirm the ability of the biofilm model to support the growth of a Gram-positive (Bacillus subtilis) and a Gram-negative (Escherichia coli) bacterial species under the same conditions of media throughput, aeration and temperature. Conclusions: This paper gives evidence of the ability to develop and control binary biofilm models to maintain the growth of two Gram-dissimilar species of bacteria. We believe this is a novel concept and will aid the future in vitro assessment of antibiotic activity in coinfection models.

doi number =10.25258/ijpcr.v9i7.8600

9. In Vitro Preliminary Phytochemical Screening and Free Radical Scavenging Ability of Drosera indica L.
K R Asha, S Hemmalakshmi, S Priyanga, K Devaki
Aim: The present study is carried out to explore the preliminary phytochemical screening and free radical scavenging activity of the whole plant Drosera indica L. Methods: a) Phytochemical screening – The qualitative analysis of secondary metabolites is carried out by the standard qualitative methods. b) In vitro free radical scavenging activity of the ethanolic and aqueous extract of the whole plant Drosera indica L is used for the analysis .Various concentrations (100 – 500mcg/ml) of the ethanol and aqueous extracts of Drosera indica L. are used in the various antioxidant assay methods such as reducing power, ferric reducing antioxidant power assay (FRAP), nitric oxide (NO) radical,2,2’ azinobis-3 ethylbenzothiozoline-6 sulfonic acid (ABTS+) radical, hydroxyl radical (OH.), 1,1-diphenyl-2-picryl hydroxyl (DPPH) radical , super oxide radical and hydrogen peroxide (H2O2) is carried out with the standard protocols. In all the assays ascorbic acid is used as the standard antioxidant. Results: Phytochemical screening of the plants reveal the presence of numerous chemicals including flavanoids, tannins, polyphenols, cardiac glycosides and saponins. The ethanolic extract of Drosera indica L. shows better ability to scavenge ,1,1-diphenyl-2-picryl hydroxyl( DPPH)radical, hydroxyl radical, hydrogen peroxide, nitric oxide radical and superoxide radical. FRAP and the reducing power abilities of the ethanolic extract is increased with the increase in concentration of the plant extract. Conclusion: The ethanolic extract of Drosera indica L. shows better ability to scavenge the free radicals than the aqueous extract. From this study, a conclusion is drawn that Drosera indica L. can have more beneficial effects with respect to the presence of many active secondary metabolites which may likely to combat with the oxidative stress diseases like diabetes, cancer, cardio-vascular diseases and in general boost the immune system.

doi number =10.25258/ijpcr.v9i7.8601

10. A Virtual Study on the Multitarget Potential Efficacy of the Ligands, Alpha Asarone and Glabridin, in Ameliorating Behavioural Deficits due to Neurodegeneration of Hippocampus Induced by Chronic Restraint Stress
Suba Malani S, Sasi Kumar A, Ramaswamy C
Life span of human, a gradually increase can occur with change in diet and life style which play an important role in delaying or even block the progression of age related degenerative problems like dementia, Alzheimer’s which decrease the cognitive function mainly learning and memory. The objective of the study was to find the multitarget potential efficacy of the ligands, Alpha asarone and Glabridin, in ameliorating behavioral deficits due to hippocampal damaged neurodegenerative condition induced by chronic restraint stress.  Hence in the current study we analyzed polypharmacological effect of the two natural compounds on the Mitogen activated protein kinases (MAPK’s) families which are mainly involved in neurodegenaration by  molecular docking using iGEMDOCK software, the drug likeliness and their absorption, digestion metabolic and toxicity profile were analyzed by DruLiTo and admetSAR software. With the results of molecular docking the two natural compounds were selected and taken for experimental study.Experimental Groups received chronic restraint stress 6hrs/day for 21days. Behavioural performance, Biochemical and Histopathological analysis of rats’ brain were estimated. Statistical analysis was done by one‑way analysis ofvariance, followed by post hoc Dunnett’s test. P<0.05 was considered statistically significant. The results suggest that both the natural compounds α asarone and Glabridin has significantly improved cognitive functions in rats subjected to chronic restrain stress. The Corticosterone concentration was decreased in rats pre-treated with α asarone and Glabridin. The results of molecular docking and further animal study in pre treatment of rats with Glabridin and αasarone before exposure to chronic restrain stress showed observable neuroprotection and improved cognition that could be due to the antioxidant action of the compounds in the rat hippocampus. Hence, these two natural compounds could be an adjuvant therapy for treatment of neurodegenerative diseases. Hence we conclude that the two natural compounds play a role in neuronal stress adaptation mechanism and have potential to prevent progression of neurodegenerative diseases.

doi number =10.25258/ijpcr.v9i7.8602

11. Tolerability and Compliance Among Patients using Long Acting Organic Nitrates
Al-Qallaf S M, Sayed Jalal Z
Purpose: The aim of this project is to examine the tolerability of patients to the various possible side effects of organic nitrate and how that would affect their compliance. Methods: A PubMed search of the literature was conducted using the terms nitrates tolerability, nitrates side effects, nitrate compliance. Data for this study was collected from a questionnaire that was distributed to 75 patients. Results: The results showed that 69% of patients have experienced side effects when they started using organic nitrates. After continued use, the incidence of side effects decreased to 19 %.  The most common side effect was reported to be headache which occurred in the first eight hours of using medication almost as one headache attack daily. Conclusion: Organic nitrates have a good tolerability and compliance among patients, it is clear that the incidence of nitrate side effects especially headache decrease with continued use which might be attributed to the tolerance that might develop with the use of nitrates. Starting nitrates in low doses and leaving a daily free interval have been reported to be associated with reduced frequency and severity of headache, and enhanced their clinical efficacy.

doi number =10.25258/ijpcr.v9i7.8603

12. Knowledge and Practice of Mothers Regarding the Prevention and Management of Malnutrition Among Preschool Children – A Cross Sectional Survey
Lija R Nath, C Kanniammal
Malnutrition remains one of the most common causes of morbidity and mortality among children throughout the world. Malnutrition has been responsible, directly or indirectly for 60% of the 10.9 million deaths annually among children under five. The research study was aimed to assess the knowledge and practice of mothers of preschool children regarding the prevention and management of malnutrition. The design used was descriptive cross sectional survey. The study was conducted in a coastal setting of Trivandrum district with a sample size of 115. Data collection was done by self administered structured questionnaire by conducting mothers meeting at selected Anganwadis. According to the results of the study 19.1% of mothers had good knowledge and 34.8 % of mothers had poor knowledge. Regarding practice only 24.3 % of mothers reported good practice while 36.6 % of mothers reported poor practice. There was a strong association between the knowledge and Practice of mothers and selected socio demographic variables such as educational status of mothers and socio economic class (p<0.01)).  The study findings can be used for planning targeted nursing interventions in coastal areas for mothers of preschool children.

doi number =10.25258/ijpcr.v9i7.8604

13. Impact of Yoga on Blood Pressure and Quality of Life in Patients with Hypertension
J Vasantha Priya, C Kanniammal, Jaideep Mahendra, G Valli
Background: Medical treatment of hypertension is not always sufficient to achieve blood pressure control. Despite this, previous studies on supplementary therapies, such as yoga, are relatively few. The investigator evaluated the effects of yoga intervention on blood pressure and quality of life in patients in selected hospital diagnosed with hypertension. Methods: Adult patients (age 20–80 years) with diagnosed hypertension were identified at OPD of Meenakshi Medical College and Hospital. In total, 83 subjects with blood pressure values of 120–179/≤109 mmHg at baseline were enrolled. At baseline, the patients underwent standardized blood pressure measurement at the health care center and they completed a questionnaire on self-rated quality of life (WHOQOL). There were three groups: 1) Yoga class with investigator (n = 28); 2) Yoga at home (n = 28); and 3) a control group (n = 27). The participants were matched at the group level for systolic blood pressure. After 12 weeks of intervention, the assessments were performed again. At baseline a majority of the patients (92%) were on antihypertensive medication, and the patients were requested not to change their medication during the study. Results: The yoga class group showed improvement in blood pressure or self-rated quality of life, while in the yoga at home group there was a decline in diastolic blood pressure of 4.4 mmHg (p < 0.05) compared to the control group. Moreover, the yoga at home group showed significant improvement in self-rated quality of life compared to the control group (p < 0.05). Conclusions: A short yoga program for the patient to practice at hospital seems to have an antihypertensive effect, as well as a positive effect on self-rated quality of life compared to controls. This implies that simple yoga exercises may be useful as a supplementary blood pressure therapy in addition to medical treatment.

doi number =10.25258/ijpcr.v9i7.8605

14. Analytical Method Development and Validation for the Analysis of Donepezil Hydrochloride and Its Related Substances Using Ultra Perfomance Liquid Chromatography
Mahalingam V, Kalaivani V, Somanathan T, Vijayabaskar S
A novel, economic and time-efficient reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method has been developed for the analysis of Donepezil hydrochloride in the presence of both impurities and degradation products generated by forced degradation. When Donepezil hydrochloride was subjected to acid hydrolysis, oxidative, base hydrolysis, photolytic, and thermal stress, degradation was observed only in oxidative and base hydrolysis. The drug was found to be stable to other stress conditions. Successful chromatographic separation of the drug from impurities formed during synthesis and from degradation products formed under stress conditions was achieved on a Waters Acquity C18, 50 mm x 2.1mm, 1.7µ particle size column, UV detection at 286nm and a gradient elution of Trifluoroacetic acid, Acetonitrile and methanol as mobile phase. The method was validated for specificity, precision, linearity, accuracy, robustness and can be used in quality control during manufacture and for assessment of the stability samples of Donepezil hydrochloride. Total elution time was about 6 min and equilibration time of about 2 min which allowed analysis of more than 100 samples per day. The analytical method discussed in British Pharmacopeia was pH sensitive and not compatible to LC-MS analysis but the method reported in this study is more compatible to LC-MS which will be more suitable to perform LC-MS.

doi number =10.25258/ijpcr.v9i7.8606

15. A Preliminary Novel Findings on Invitro Anti-Coagulant Activity of  Acalypha Indica Linn Leaf Extracts
Ashwini U,  Asha S
The current study focuses on anticoagulant activity of leaf extract of Acalypha indica (A.indica) and to identify the active constituents present and responsible for the anti-coagulation activity. On sequential extraction of plant materials with petroleum ether, chloroform, ethyl acetate, n-butanol, ethanol and aqueous, crude extracts were obtained and screened for anti-coagulant activity. Anticoagulant activity of six different leaf extracts of A.indica was tested using prothrombin time (PT). In vitro anticoagulation assays were performed with different concentrations of the leaf extract on citrated plasma obtained from healthy volunteer donors. The different concentrations of crude extract tested in the present study were 0.062, 0.125, 0.25 and 0.5 gm/ml. The anti-coagulant activity of six extracts exhibited a concentration dependent activity. Among the six tested extracts, petroleum ether exhibited a highest activity by increased prothrombin time of 60min and 5 sec at 0.5gm/ml compared to positive and negative control. This is followed by aqueous, n-butanol, chloroform and ethyl acetate extract. It was also noted that ethanol extract showed no prolonged prothrombin time and it was within the normal level as compared to the control. Phytochemical screening of different extracts revealed the presence of steroids, terpenoids, tannin, phenols, flavonoids and alkaloids as secondary metabolites. From the results, for the first time it was highlighted that the A.indica leaf extracts affects the intrinsic pathway of coagulation cascade and thus prolongs the clotting time, hence this plant can be used in the management of blood clotting diseases.

doi number =10.25258/ijpcr.v9i7.8607

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