A COMPARATIVE CLINICAL TRIAL ON EGG YOLK BASTI & VIDARIKANDADI GRANULES IN CHILDHOOD KARSHYA

In this modern era of changing lifestyles, people and children cannot follow the rules of Dincharya and Ritucharya. Children have insufficient nutrients due to irregular food habits, which are triggering factors that cause childhood Karshya, resulting in mental and physical conditions that will not adequately develop. Biological and mentally healthy children are vital parts of a well-developed Nation, and this can be done by supplying nutritional requirements. The research was conducted in Bal Rog OPD, SAC and Hospital Lucknow. In this clinical trial total of 50 patients were selected and divided into group A and group B, having 25 in each group. Group A was treated with Egg Yolk Basti, and group B was treated with Vidarikandadi Granules for three months. In group A, 14 (56%) patients were relieved, 7 (28.0%) patients were moderately improved, 3 (12.0%) patients were mildly improved, and one patient did not show any response. In group B, 13 (52%) patients were relieved, 8 (32.0%) patients were moderately improved, 3 (12.0%) patients were mildly improved, and one patient did not show any response. This study indicates that Egg Yolk Basti and Vidarikandadi Granules can be effective in childhood Karshya.

One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial

Background: We aimed to compare 1 year the hemodynamic in-vivo performance of three biological aortic prostheses (Carpentier Perimount Magna EaseTM, Crown PRTTM, and TrifectaTM). Methods: The sample used in this study comes from the “BEST-VALVE” clinical trial, which is a phase IV single-blinded randomized clinical trial with the three above-mentioned prostheses. Results: 154 patients were included. Carpentier Perimount Magna EaseTM (n = 48, 31.2%), Crown PRTTM (n = 51, 32.1%) and TrifectaTM (n = 55, 35.7%). One year after the surgery, the mean aortic gradient and the peak aortic velocity was 17.5 (IQR 11.3–26) and 227.1 (IQR 202.0–268.8) for Carpentier Perimount Magna EaseTM, 21.4 (IQR 14.5–26.7) and 237.8 (IQR 195.9–261.9) for Crown PRTTM, and 13 (IQR 9.6–17.8) and 209.7 (IQR 176.5–241.4) for TrifectaTM, respectively. Pairwise comparisons demonstrated improved mean gradients and maximum velocity of TrifectaTM as compared to Crown PRTTM. Among patients with nominal prosthesis sizes ≤21, the mean and peak aortic gradient was higher for Crown PRTTM compared with TrifectaTM, and in patients with an aortic annulus measured with metric Hegar dilators less than or equal to 22 mm. Conclusions: One year after surgery, the three prostheses presented a different hemodynamic performance, being TrifectaTM superior to Crown PRTTM.

AN AMELIORATE COMPARATIVE CLINICAL TRIAL OF NAVAYAS LOUHA SYRUP AND NISHA LOUHA SYRUP IN THE MANAGEMENT OF PANDU ROGA WITH SPECIAL REFERENCE TO IRON DEFICIENCY ANEMIA IN CHILDREN

Anemia is a major health problem in India. Yet, a comprehensive plan of action to combat this public health problem has been still missing. There are few existing plans for the control of Iron Deficiency Anemia regarding children and pregnant women and lactating mothers. Iron deficiency is the result of long-term negative iron balance. Iron deficiency anemia (IDA) should be regarded as a subset of iron deficiency, that is, it represents the extreme lower end of the distribution of iron deficiency. Treatment options include oral and intravenous iron therapy; however, the efficacy of oral iron is limited in certain gastrointestinal conditions, such as inflammatory bowel disease, celiac disease, and autoimmune gastritis. So that ameliorate comparative clinical trial was taken with Ayurveda formulation for the diagnosis and treatment of iron deficiency anemia (IDA) with special reference to Pandu Roga. Overall, in the study Navayas Louha was found to have 76.53% and of Nisha Louha was found to have 69.33% clinical efficacy. The study showed that trial clinical efficacy of Navayas Louha syrup is better than Nisha Louha syrup in the management of iron deficiency anemia in Indian children.

Performance of RT-PCR on saliva specimens compared to nasopharyngeal swabs for the detection of SARS-CoV-2 in children: A prospective comparative clinical trial

Background: Saliva RT-PCR is an attractive alternative for the detection of SARS-CoV-2 in adults with much less known in children. Methods: Children and adolescents with symptoms suggestive of COVID-19 were prospectively enrolled in a comparative clinical trial of saliva and nasopharyngeal (NP) RT-PCR between November and December 2020. Detection rates and sensitivities of saliva and NP RT-PCR were compared. Participants with discordant NP and saliva RT-PCR results including viral load (VL) were also analyzed. Result: Out of 405 patients enrolled, 397 patients had two tests performed. Mean age was 12.7 years (range 1.2-17.9). Detection rates were 22.9% (95%CI 18.8-27.1%) by saliva RT-PCR, 25.4% (21.2-29.7%) by NP RT-PCR, and 26.7% (22.4-31.1%) by any test. The sensitivity of saliva was 85.2% (78.2-92.1%) when using NP as the gold standard; in contrast, when saliva was considered the gold standard, the sensitivity of NP was 94.5% (89.8-99.2%).For a NP RT-PCR VL threshold of ≥103 and ≥104 copies/ml, sensitivity of saliva increases to 88.7% and 95.2% respectively. Sensitivity of saliva and NP swabs was respectively 89.5% and 95.3% in patient with symptoms less than 4 days (p=0.249) and 70.0% and 95.0% in those with symptoms ≥ 4 to 7 days (p=0.096). The 15 patients who had an isolated positive NP RT-PCR were significantly younger (p=0.034), had a lower NP VL (median 5.6x103 vs 3.9x107, p<0.001), and were not able to drool saliva at the end of the sampling (p=0.002). VLs were significantly lower with saliva PCR than with NP RT-PCR (median 8.7 cp/ml x104; IQR 1.2x104-5.2x105; vs median 4.0x107cp/ml; IQR 8.6x105-1.x108; p<0.001). Conclusion: Saliva PCR shows diagnostic performances close to NP RT-PCR for SARS-CoV2 detection in most symptomatic outpatient children and adolescents.

Protocol for a multi-site, cluster‐randomized, phase III, comparative clinical trial of geriatric assessment of older patients with non‐small‐cell lung cancer: the ENSURE-GA study

Background In Japan, approximately half of all lung cancer patients are aged > 75 years, and the proportion of older patients is increasing. In older patients, it is necessary to consider comorbidities and concomitant drug use to ensure optimal cancer treatment; however, geriatric assessment (GA) is not widely performed. We plan to conduct a study (ENSURE-GA) of GA in older lung cancer patients to determine whether GA with intervention improves patient satisfaction with their treatment. Methods The study will be a phase III comparative clinical trial with a cluster-randomized design, and it will be conducted at 81 sites distributed throughout Japan. Approximately 1000 lung cancer patients aged ≥ 75 years will be enrolled in the study. All participants will undergo a standardized GA before starting treatment (using an iPad). At the intervention sites, the GA results and intervention method recommended on the basis of the GA results will be returned as an instant report to guide the physician’s choice of intervention. At the control sites, the physician will decide on interventions based on standard practice. All participants will complete a patient satisfaction survey before treatment initiation (after the GA) and 3 months later. Discussion The purpose of the ENSURE-GA study is to evaluate whether GA with interventions improves patient satisfaction with treatment outcomes. The study may lead to the increased use of GA and improved treatment of cancer in older adults. The results will also be used to prepare guidelines for treating older cancer patients and will provide a foundation for the development of a standardized geriatric oncology system. Trial registration The study has been registered in the University Hospital Medical Information Network database (no. UMIN000037590). The registration date is August 4, 2019, and the protocol version is 2.0. (https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042853.)