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1.
Article in English | WPRIM | ID: wpr-923061

ABSTRACT

@#Introduction: Pre-operative identification of patients with inadequate hamstring graft for anterior cruciate ligament reconstruction is still a subject of interest. The purpose of this study is to correlate dimension of a harvested dimensions graft with patient physical anthropometric variables. Materials and methods: This cohort study included 280 patients (male = 226, female = 54) scheduled for primary anterior cruciate ligament (ACL) reconstruction. Interrelationships between quadruple semitendinosus (ST) graft and anthropometric parameters (age, sex, height, weight, and BMI) were assessed using Pearson Correlation test and regression analysis. Difference among gender was analysed using Mann Whitney and t test. The observed graft diameter was also compared with the literature using Bland – Altman plot. Results: Mean age of cohort was 29 years (range, 17-50 years), mean height was 1.69m (range, 1.6-1.9m), mean weight was 75 kg (range, 50-116kg) and mean BMI was 26kg/m2 (range 16.65-40.40kg/m2). Mean quadruple length of harvested ST graft was 7cm (7.1±0.6 cm, range, 5.6- 8.8cm) and mean diameter was 8mm (8.2±0.8mm, range, 6.5-10mm). Only height and weight were significantly correlated with graft length and diameter in both sex (p value <0.05). Female, compared to male, had significantly smaller (p<0.0001) and thinner graft (p<0.0001). There was a strong agreement between the literature and our observed graft diameter, but with an overestimated graft diameter in 18.5% of the cases. Conclusion: Among anthropometric parameter, only height and weight had moderate positive correlation with graft diameter. Males had longer and wider ST graft in contrast to age-matched female group.

2.
Int J Pharm Pharm Sci ; 2020 Aug; 12(8): 111-116
Article | IMSEAR | ID: sea-206006

ABSTRACT

Objective: The objective of the present study is the evaluation of the effect of the sublethal (40% and 60% of 48h LC50) binary combination (1:5 ratios) of molluscicides deltamethrin+MGK-264 on the endogenous levels of protein, amino acid and nucleic acid in different tissues of snail Lymnaea acuminata. Methods: The snails were treated with 1:5 mixtures of sub-lethal concentration of (40% and 60% of 48h LC50) deltamethrin+MGK-264 on the protein, amino acid and nucleic acid levels in gonadal, nervous and foot tissue of L. acuminata. In order to study the effect of withdrawal from treatment, the snails were first exposed to the above concentrations for 96h, after which they were transferred to freshwater. Water was changed every 24h for the next seven days, after which different biochemical parameters were estimated. Results: There was a significant change in the levels of protein (sublethal concentration of 60% of 48h LC50 after 96h) gonadal, nervous and foot tissues are 48.1, 12.1 and 14.5%, respectively, amino acid are 273, 234 and 252%, respectively, DNA are 25.1, 38.9 and 42.1%, respectively and RNA are 12.2, 30.7 and 30.5%, respectively. These changes were time and concentration-dependent. In the withdrawal experiment, the snails were treated for 96h to transfer in freshwater for 7 d, which caused significant recovery in all the biochemical parameters. Conclusion: The present study concluded that the high molluscicidal activity of deltamethrin+MGK-264 simultaneous decrease in the levels of proteins, DNA, RNA and increase in the level of amino acids.

3.
J Environ Biol ; 2020 Jul; 41(4): 796-802
Article | IMSEAR | ID: sea-214545

ABSTRACT

Aim: The present study was aimed to understand the prevalence of heifer mastitis and its associated risk factors in Jammu region.Methodology: A total of 250 pregnant heifers (1000 quarters) were screened, and lacteal secretions were collected from 915 quarters individually, in order to estimate the prevalence of heifers mastitis by culturing. The prevalence was estimated based on the results of microorganism culture. Results: The overall prevalence of heifer mastitis was 90.80% by cultural examination whereas only 30% of the animals produced clinical signs. The prevalence was higher in organized management system and prime risk factors associated with mastitis were season of calving, prepartum intra-mammary infections, poor udder hygiene, etc., in both organized and unorganized managements. Interpretation: High pre-valence of heifer mastitis (as evidenced by presence of microorganisms) is alarming situation for dairy farming in India. Season of calving, milk leakage at calving, prepartum IMI, poor udder hygiene, sanitation, beddings, floor type, and contact of heifers with older cows could be the important risk factors.

4.
Article | IMSEAR | ID: sea-210917

ABSTRACT

Present study was undertaken to study the neurotoxicity of oral acrylamide (ACR) and its amelioration using α-tocopherol, reduced glutathione (GSH) and hot aqueous extract (HAE) of Ocimum sanctum. Forty five male Wistar rats were divided into 12 groups. The study showed a significant reduction in the body weight of the rats fed with ACR in comparison to the other groups while body weight was restored in the rats fed with α-tocopherol and HAE. Neurotoxicity in rats fed with ACR was evident with the results of histopathology and oxidative stress (high MDA and decreased activities of GSH, SOD, GST and CAT in brain). Co-administration of α-tocopherol and HAE lowered these changes however, there was no marked improvement seen in neural damage but improvement was evident in behavioral as well as physiological changes at a marked point. Histopathology of brain in ACR alone fed group showed extensive neural degeneration and massive deposition of fibrin which was substantially decreased and ameliorated with the co-administration of α-tocopherol and HAE. These results support the oxidative stress results as well. Our results suggests that α-tocopherol and HAE can be useful for protecting brain tissue against ACR induced neurotoxicity through minimizing the free radical mediated oxidative stress

5.
Indian J Ophthalmol ; 2020 Mar; 68(3): 500-503
Article | IMSEAR | ID: sea-197838

ABSTRACT

Purpose: To study the epidemiology of mechanical ocular trauma and closed globe injury using the Birmingham Eye Trauma Terminology System in patients belonging to the pediatric age group. Methods: This work involved a prospective cohort study of all ocular trauma patients (pediatric age group) registered between 2002 and 2017 at the ocular trauma care center. The data were collected using the international ocular trauma society form through our online MIS data and exported to the Excel sheet. The statistical analyses including the univariate analysis and cross tabulation were carried out using SPSS 22 software. Results: Our cohort consisted of 12687 patients with mechanical ocular trauma. There were 7546 (59.4%) eyes with open globe ocular injuries and 5328 (41.9%) with closed globe injuries. Of all closed globe injury patients, 1010 (19.0%) belonged to the pediatric age group (0-18 years), including 690 males (68.3%) and 320 females (31.7%). The mean age of the patients was 10.2 ± 5.1 years. Of all closed globe injuries, 692 (68.5%) were closed globe contusion and 318 (31.5%) were lamellar laceration. Conclusion: Closed globe injury is an important in cause of vision loss in children (24% <1/60). The condition is more prevalent in males and >51.7% in children under 10 years of age. The treatment has significant impact on the visual outcome in patients belonging to the pediatric age group.

6.
J Environ Biol ; 2020 Mar; 41(2): 234-239
Article | IMSEAR | ID: sea-214499

ABSTRACT

Aim: A study was conducted to develop a new approach of non-stress baseline and evaluate different approach of determining non stress baseline for Crop Water Stress Index (CWSI).Methodology: To observe maximum and minimum canopy temperature, two plots with three replications were maintained at fully stress (no irrigation) and no stress (fully irrigated) conditions, respectively. Portable weather station with data logger was installed at the middle of field to record continuous data at half an hour interval. Gypsum block soil moisture sensor were buried at 20 cm interval up to 100 cm and connected with data logger. Infrared radiometer was used to measure canopy temperature. Results: The evaluation was based on five statistical indicators; correlation coefficient (R2), root mean square error (RMSE), mean absolute error (MAE), mean bias error (MBE) and Wilmot index of agreement (d). It was found that new regression base line performed better than other existing approaches. The calculated value of RMSE, MAE, MBE, d and R2 were 0.65, 0.51, 0.02, 0.79 and 0.83, respectively, for new baseline approach. Interpretation: The newly developed multiple regression equation (incorporating three weather parameters (Rn, VPD and u) and two crop growth parameters (h and CC)) helped to reduce error in the calculation of non-stress baseline for wheat crop in humid subtropical climate

7.
Article | IMSEAR | ID: sea-204851

ABSTRACT

The impacts of climate change on water quality of water bodies are associated with the climatic extreme events (heavy rainfall and flood, heat, drought, wildfires, cyclones, hurricane, super storms) as the major drivers that require knowledge of understanding. Most research studies present the role of climate change in threatening water quality, risks on drinking water and contributions of catchment in water pollution, but less attention has directed to specific sensitive water quality parameters, appropriate methodologies, risks on ecosystem and managerial practice to reduce the impacts. This review highlight the of effect climate change on surface water bodies based on recent literatures on the impacts of climate change on water quality and promote practical opportunity for better management of these impacts. We conclude that consideration of climate change preparedness plan in catchments is the best option to adopt for minimization of climate change impacts on water quality of water bodies.

8.
Indian J Ophthalmol ; 2020 Jan; 68(1): 126-129
Article | IMSEAR | ID: sea-197724

ABSTRACT

Purpose: To describe the the appearance and behavior of subretinal hyperreflective material (SHRM) in eyes with central serous chorioretinopathy (CSCR). Methods: This retrospective study included 20 eyes of 20 patients with CSCR presenting with SHRM, defined as sub-retinal deposits that appear hyper-reflective on OCT The eyes underwent either laser (15 eyes) or observation (5 eyes). Optical coherence tomography and fundus fluorescein angiography (FFA) characteristics were analyzed at baseline and resolution of neurosensory detachment, which were then co-related with the visual acuity at resolution. Results: Improvement in vision was seen in 16 eyes. Ellipsoid zone damage (P = 0.03) and external limiting membrane (ELM) damage (P = 0.000) at resolution; diffuse retinal pigment epithelium (RPE) abnormalities on FFA (P = 0.04), and the presence of scar (P = 0.000), were associated with poor visual outcome in univariate analysis. ELM damage at resolution was statistically significant (P = 0.001) in multivariate analysis. Conclusion: CSCR with SHRM have a good visual prognosis. ELM damage at resolution corelates with a poor visual acuity at resolution.

9.
J Environ Biol ; 2020 Jan; 41(1): 111-117
Article | IMSEAR | ID: sea-214481

ABSTRACT

Aim: The objective of the present study was to identify economically viable, profitable and resource efficient vegetables embedded rice-based cropping sequences under organic management for marginal and small farmers of Sikkim Himalayas, India.Methodology: Three-year fixed plot study was conducted to evaluate seven rice–based cropping sequences viz., rice–fallow (farmers’ practice), rice–fenugreek (leafy vegetable), rice–coriander (leaves), rice–radish, rice–broccoli, rice–potato and rice–vegetable pea were replicated four-times in a completely randomized block design. Results: Among the various rice – based cropping sequences, cultivation of rice–coriander (leaves) recorded higher production (67.3 kg ha-1 day-1), system productivity (24.6 t ha-1), relative economic efficiency (1040%) and net returns (376.1x103). However, rice-broccoli and rice–vegetable pea sequences recorded 8.6 and 4.4% higher B: C ratio, respectively, over the rice–coriander system. With regards to soil health, rice – vegetable pea cropping sequences resulted in maximum improvement in soil organic carbon (SOC) (1.26%), available soil N (415.2 kg ha-1), P (22.8 kg ha-1) and K (411.5 kg ha-1), soil microbial biomass carbon (SMBC) (344.7 µg MBC g-1 soil), dehydrogenase activity (DHA) (24.0 µg TPFg-1 soil h-1) and fluorescin di acetate (FDA) (38.8 µg FDAg-1 soil h-1) among the cropping sequences. Interpretation: Induction of vegetables in rice–fallow system under assured irrigation condition of Sikkim Himalayas, India not only enhances the farm productivity and profitability but also sustain the soil health on long term basis. Thus, rice-vegetable pea/coriander/broccoli based production systems under organic management hold great promises for sustaining livelihood of organic growers in Sikkim Himalayas over conventional rice– fallow system.

11.
J Environ Biol ; 2019 Nov; 40(6): 1227-1233
Article | IMSEAR | ID: sea-214462

ABSTRACT

Aim: The study aimed to evaluate the effects of hydrogel application on growth, physiological responses and yield of capsicum under high altitude cold desert conditions with deficit irrigation of Ladakh region. Methodology: Field experiment was conducted with five levels of hydrogel treatment (viz. 0, 5, 10, 15 and 20 kg ha-1) at cold desert Ladakh region with two irrigation intervals (7 and 11 days) during 2014-15 cropping season. Plant growth characters, root morphology, physiological parameters and capsicum yield were analyzed according to standard methods during the experiments. Results: Hydrogel application in deficit irrigation improved physiological parameters viz. leaf chlorophyll content, relative water content, membrane stability index and significant reduction in electrolyte leakage in capsicum plant. Significant improvement in root morphology was also recorded when hydrogel was applied @ 15 and 20 kg ha-1. Improvement of yield attributing characters as influenced by hydrogel application @ 15 and 20 kg ha-1 resulted in significant increase in capsicum yield with reduced water requirement. Interpretation: Hydrogel has potential for growth of capsicum crop through improved root morphology and physiology of plant in deficit irrigation under arid and semi-arid regions where availability of water for irrigation is scarce or average rainfall is quite low.

12.
Article | IMSEAR | ID: sea-206271

ABSTRACT

This work focused on the biogenic synthesis of silver nanoparticles (AgNPs) by silver nitrate using Celosia cristata leaves extract in four different solvents namely petroleum ether, acetone, methanol, and water. Silver nitrate and leaves extract were used as a precursor and capping reducing agent respectively. Biogenic AgNPs were characterized and identified by UV-Vis spectrophotometer, X-ray diffraction (XRD), Field emission scanning electron microscope (FE-SEM), and energy dispersive spectroscopy (EDX). Disc diffusion method was used for antibacterial activity of AgNPs and effective antibacterial activity was shown against IS-3, IS-4, IS-6, and IS-7 as compared to a positive control (ciprofloxacin).

13.
Article | IMSEAR | ID: sea-196055

ABSTRACT

Background & objectives: Mouse is a preferred animal model for studying pathogenesis of Japanese encephalitis virus (JEV) infections, and different routes of inoculation have been tried. Some neurotropic viruses can reach the brain following infection through ocular route. This study was undertaken to establish JEV-induced clinical disease in mouse model through conjunctival route and document the neuropathological effects. Methods: Ten two-week old Swiss albino mice were inoculated with 5 ?l Vero cell cultured virus containing 104.7 TCID50 JEV through conjunctival route. Clinical signs of mice were observed twice daily. After necropsy examination, different organs including eyes and olfactory bulbs were collected for histopathological examination, quantification of viral copy number and antigen by real-time TaqMan assay and immunohistochemistry, respectively. Results: Infected mice showed characteristic clinical signs of JE by 4 days post-infection (dpi). Histopathological lesions in brain included perivascular cuffing by mononuclear cells, focal gliosis, necrosis of neurons and neuronophagia and astrocytosis in the cerebrum, cerebellum and the brainstem. JEV viral load was highest in the brain followed by intestine, heart, liver, spleen, lung and kidney. JEV antigen was detected in the bipolar and ganglion cells of the retina and in the mitral cells and periglomerular cells of olfactory bulb and other parts of the brain. Interpretation & conclusions: JEV infection in mice through conjunctival route produced characteristic clinical signs of the disease and neuropathological lesions. Demonstration of JEV antigen in association with neuropathological lesions in the central nervous system and neuronal cells of the eye showed that conjunctival route could be an effective alternate route for virus invasion into the brain. These findings have biosafety implications for researchers, veterinary practitioners and pig farmers.

14.
Int J Pharm Pharm Sci ; 2019 Sep; 11(9): 57-64
Article | IMSEAR | ID: sea-205950

ABSTRACT

Objective: The aim of the present study was to prepare the ondansetron hydrochloride Mouth Dissolving Tablets (MDTs) followed by its comparison with ethical and non-ethical (generic) marketed tablets. Methods: Prior to the formulation, drug excipient compatibility study was carried out by FTIR spectroscopy. The λmax was determined by UV spectroscopy. The ondansetron hydrochloride MDTs were prepared by direct compression method using Sodium Starch Glycolate (SSG) as super disintegrant and camphor as a sublimating agent. Then the prepared MDTs were subjected to evaluation of post compression parameters such as thickness and diameter, weight variation, wetting time, hardness, friability, disintegration and dissolution. The results obtained were compared with that of ethical and non-ethical marketed ondansetron hydrochloride 4 mg tablets. Results: The λmax was found at 310 nm. FTIR study revealed that excipients used in the prepared formulations are compatible with the drug. The thickness and diameter was in the range of 2.646 to 3.27 mm and 6.0 to 8.12 mm, respectively. Friability was in the range of 0.43 to 0.88 % and had a slightly higher friability (1.27%) for sublimated tablets. Wetting time and disintegration time were in the range of 15 to 40 sec and 23 to 50 sec, respectively. The 100 % drug release was found within 180 sec for all the codes. These results were then compared with non-ethical film coated ondansetron marketed tablets. Conclusion: Ondansetron hydrochloride MDT 4 mg tablets prepared in the laboratory were under specified IP limits. The experimental findings demonstrated that any of these ethical and non-ethical tablets of ondansetron hydrochloride can be selected, advised by the physician or pharmacist, as per the patient’s need and economical status.

15.
Int J Pharm Pharm Sci ; 2019 Aug; 11(8): 85-91
Article | IMSEAR | ID: sea-205940

ABSTRACT

Objective : Gamma radiation induces free radicals with a corresponding alteration in the cell’s antioxidant defense system. The present study thus aimed at determining the role of gamma irradiation in improving the cosmeceutical potential of CEK in terms of antioxidants.  Methods : C.emersonii KJ725233 was subjected to low (100 Gy) and high (1000 Gy) gamma irradiation doses and its effect on the chlorophyll content was evaluated. The quantitative alterations in the antioxidant content of CEK were evaluated by phosphomolybdenum assay (TAC), ferric reducing antioxidant potential (FRAP), 2, 2 - Dipheny-1-picryl hydrazyl radical scavenging assay (DPPH), total phenolic (TPC) and total flavonoid content (TFC). Also, the corresponding qualitative alterations in the bioactives of CEK were determined by GC-HRMS analysis.   Results : A 179.57±2.55% increase in the total chlorophyll content alongwith a 71.76±2.96%, 32.08±2.16%, 11.67±0.89%, 42.85±8.0% and 31.37±3.18% increase was observed in the TAC, FRAP, DPPH radical scavenging, TPC and TFC was observed in CEK irradiated at 1000 Gy. GC-HRMS analysis revealed the induction of Vitamin E on irradiation at both the doses with a corresponding decrease in the phytol content whereas 100 Gy stimulated the induction of phytosterols. Conclusion : The potent intrinsic antioxidant activity of cosmeceutically significant CEK can be elevated with the induction of the most sought after antioxidant in cosmetology – Vitamin E on irradiation.

16.
Indian J Ophthalmol ; 2019 Jul; 67(7): 1095-1100
Article | IMSEAR | ID: sea-197347

ABSTRACT

Purpose: Diagnosis of choroidal neovascular membrane (CNVM) is difficult in chronic central serous chorioretinopathy (CCSC) due to overlapping features of both on conventional dye angiography. Optical coherence tomography angiography (OCTA) allows a quick and noninvasive detection of CNVM in these eyes. We compared the fluorescein angiography (FA) features of CNVM with those of OCTA to assess the role of FA in detecting CNVM in CCSC eyes. Methods: Patients with CCSC undergoing FA, spectral domain (SD)-OCT, and OCTA were identified (March 2015–June 2015). Four retina specialists individually reviewed FA images (without OCTA and SD-OCT) to determine whether CNVM was present. In parallel, two other retina specialists reviewed all images (FA/SD-OCT/OCTA) for CCSC features and confirmed whether CNVM was present using OCTA as the gold standard. The inter- and intraobserver variability was measured by Kappa (k) coefficient. The FA features of CNVM were compared and correlated with those on OCTA. Results: Of 43 eyes (26 patients, mean age 45.6 ± 8.5 years, all males), a definite CNVM (detected by OCTA) was present in nine (20.9%) eyes. FA alone detected CNVM in 13 (30.2%) eyes [sensitivity 44.4% (95% confidence interval (CI): 11.9–76.9), specificity 73.5% (95% CI: 58.7–88.3), positive and negative predictive values 30.8% and 83.3%, respectively, and accuracy 67.44% (95% CI: 53.4–81.4)]. Conclusion: When compared with OCTA, the FA was unable to characterize CNVM in CCSC (with a very low sensitivity and moderate specificity) as none of the specific dye leakage patterns on FA correlated with CNVM seen on OCTA, limiting its usefulness and accuracy in detecting CNVM in these eyes.

17.
Article | IMSEAR | ID: sea-211583

ABSTRACT

Background: The gastrointestinal tract of the HIV/AIDS patient (s) is harboured by a number of luminal extracellular and intracellular parasites. These parasites are responsible for deteriorating and worsening the general health condition(s) of these immunocompromised groups of patients. Moreover, these parasitic infections are often correlated with the CD4 counts of the individuals. Therefore, with a view to assess the relationship between the presence of parasitic infection and that of the CD4 count, the present work is being undertaken.Methods: The study was conducted in the Parasitology section of the department of Life Sciences, Manipur University and CD4 count unit of Microbiology Department, RIMS hospital Imphal from 34 HIV positive Antiretroviral treatment (ART) naive patients, aged between 19 to 50 years. The samples were taken from the patients only after obtaining a signed consent form . Techniques like normal saline method, iodine wet preparation method, formol ethyl acetate concentration technique, Baermann modified funnel technique, modified Ziehl Neelsen staining technique and adhesive cellophane tape method were employed for the present investigation.Results: The present study reveals that patients with CD4 count <200 cells/μl were harbouring only two parasites (Cryptosporidium sp and G. lamblia) whereas individuals with CD4 count within the range of 200-500 cells/μl were observed to have harboured G. lamblia, Cryptosporidium sp, E.histolytica, hookworm, S. stercoralis and A. lumbricoides. On the other hand, enteric parasites associated with CD4 count >500 cells/μl included G. lamblia, hookworm, E. vermicularis and S. stercoralis.Conclusions: The present study shows that occurrence of intestinal parasitism is independent of CD4 count in HIV infected patients. Therefore, based on the present findings, it may be suggested that irrespective of CD4 count(s) and whether the patient experiences diarrhoea or not, regular monitoring of the HIV patient(s) for the presence of enteric parasitosis by adopting standard laboratory protocols should be encouraged for maintaining a healthy life of the people living with HIV/AIDS.

18.
Article | IMSEAR | ID: sea-204793

ABSTRACT

The purpose of this article is to provide planners with an introduction to the concept of green buildings and building assessment systems and to identify and explore the major themes in the literature as they relate to planning. Green building is one of the measures that has been put forward to alleviate the remarkable impacts of the building stock on the environment, society and economy. GRIHA (Green Rating for Integrated Habitat Assesment) is a rating instrument that helps individuals evaluate their building's efficiency against certain benchmarks that are acceptable nationwide, it evaluates a building's environmental efficiency over its entire life cycle holistically. This paper reports a critical review of the GRIHA rating system and incentives provided by GRIHA in India, techniques, and methods for construction of the green building, financial aspects of the green building. The efficiency of different environment-friendly models is broadly discussed in this study. The purpose of this paper is to explore the benefits of green building in order to proceed towards sustainable construction in the future.

19.
Article | IMSEAR | ID: sea-195968

ABSTRACT

Corneal blindness is one of the major causes of reversible blindness, which can be managed with transplantation of a healthy donor cornea. It is the most successful organ transplantation in the human body as cornea is devoid of vasculature, minimizing the risk of graft rejection. The first successful transplant was performed by Zirm, and since then, corneal transplantation has seen significant evolution. It has been possible because of the relentless efforts by researchers and the increase in knowledge about corneal anatomy, improvement in instruments and advancements in technology. Keratoplasty has come a long way since the initial surgeries wherein the whole cornea was replaced to the present day where only the selective diseased layer can be replaced. These newer procedures maintain structural integrity and avoid catastrophic complications associated with open globe surgery. Corneal transplantation procedures are broadly classified as full-thickness penetrating keratoplasty and partial lamellar corneal surgeries which include anterior lamellar keratoplasty [sperficial anterior lamellar keratoplasty (SALK), automated lamellar therapeutic keratoplasty (ALTK) and deep anterior lamellar keratoplasty (DALK)] and posterior lamellar keratoplasty [Descemet stripping automated endothelial keratoplasty (DSAEK) and Descemet membrane endothelial keratoplasty (DMEK)] broadly.

20.
Article | IMSEAR | ID: sea-195951

ABSTRACT

Background & objectives: For improved male contraception, a new polymeric drug molecule – Reversible Inhibition of Sperm under Guidance (RISUG) has been synthesized and has been found to be effective, safe and reversible in various animal species. Phase-I and phase-II clinical trials have confirmed its safety and contraceptive efficacy. The present study was undertaken as a multicentric-limited phase-III clinical trial to test the efficacy and safety of RISUG in human volunteers. Methods: One hundred and thirty nine young males each having at least two children and living with wife were given 120 ?l of RISUG as bilateral vas intraluminal injection. After the single-dose administration, the individuals were followed in respect of general health and semen parameters. Their wives were also followed particularly to determine onset of pregnancy. Results: During the six month follow up, the health of male volunteers and their wives was normal with no significant adverse effects. Temporary scrotal enlargement and mild scrotal and inguinal region pain were manifested in most individuals and resolved within one month without any routine activity impairment. In six individuals, there was injection procedure failure and azoospermia was not achieved. The other 133 individuals had either severe oligozoospermia or azoospermia at the first semen examination one month following RISUG injection; 82.7 per cent individuals had continued azoospermia in the month following first semen examination onwards and the rest 17.3 per cent manifested azoospermia within three to six months. Interpretation & conclusions: RISUG intravasal injection appears to be a safe clinical procedure with no significant adverse effects and has high sustained contraceptive efficacy. The localized intervention and continued contraceptive action on single-dose administration were significant features of the RISUG technology.

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