scholarly journals A randomized, comparative, open clinical trial for evaluating the efficacy of PP/JLN/107/09-10 Syrup in the management of Functional Constipation

2020 ◽  
Vol 5 (06) ◽  
pp. 43-50
Author(s):  
M. Ramadas ◽  
Padmanabha Rugvedi ◽  
Pankaj Kumar Gupta ◽  
Rajiva Kumar Rai ◽  
JLN Sastry

Context: Functional constipation which has no underlying organic causes is difficult to be allopathic treatment for long term due to its side effects and undeniable effect, thus a natural balanced and compatible formulation needs to be validated. Objectives: Current study aimed to assess a poly-herbal formulation in management of functional constipation. Material and Methods: This study was 28 days, two armed, randomized, open labeled, prospective clinical study. 60 clinically confirmed cases of functional constipation patients randomized to receive orally either 2 teaspoonful of PP/JLN/107/09-10 Syrup or 1 teaspoonful of 5- 6 gm of Isabgol powder. Results were analyzed as per Rome II criteria and other associated symptoms like headache, acidity, belching, barborgysmy, flatulence and abdominal dis tension or bloating which are recorded on VAS score. Results: PP/JLN/107/09-10 scored over Isabgol on four out of six parameters of Rome II Criteria viz., frequency of bowel movement, straining at defecation, lumpy I har dstool formation, feeling of incomplete evacuation, feeling of ano-rectal blockage and manual maneuvers (p less than 0.001). Trial drugs showed comparable effects (p > 0.05) in reducing the mean scores of associated symptoms like headache, acidity, belching, borgorgysmy, flatulence and abdominal distension. However, trial drug was found to perform statistically significant result in more number of parameters in comparison to Isabgol. Conclusion: PP/JLN/107/09-10 was found to be effective and safe in reliving functional constipation.

2005 ◽  
Vol 19 (5_suppl) ◽  
pp. 15-21 ◽  
Author(s):  
W. Kissling ◽  
S. Heres ◽  
K. Lloyd ◽  
E. Sacchetti ◽  
P. Bouhours ◽  
...  

This report presents data from the extension phase of a 6-month trial that evaluated the efficacy of risperidone long-acting injectable (RLAI) in stable psychotic patients requiring a treatment change. Patients continued to receive RLAI every 2 weeks for a maximum of 12 months from study entry. Symptoms were assessed using the PANSS after 1, 3, 6, 9 and 12 months of treatment (or treatment endpoint). Remission of severity criteria were defined as ≤3 points in all PANSS items suggested by the Remission in Schizophrenia Working Group. 715 patients (63% male) entered the extension phase and 508 completed the 12-month study. The mean PANSS total score at Day 0 was 74.9±22.7. This was significantly reduced after 1 month (67.7 ±22.3, p≤0.001), with continued improvements over the 12 months of the study until treatment endpoint (59.7±21.9). Significant improvements from Day 0 to endpoint were also seen in the scores for all PANSS subscales and symptom factors. The proportion of patients who met the PANSS severity criteria for remission increased from 29% at Day 0 to 60% at endpoint, and the proportion of patients who met these criteria for ≤ 6 months increased from 24% at Month 6 to 45% at endpoint. Treatment with RLAI for up to 12 months provided significant and sustained improvements in symptom control in patients with schizophrenia. These improvements may help patients to achieve and remain in remission.


2020 ◽  
Vol 32 (1) ◽  
pp. 36-41 ◽  
Author(s):  
Yossi Smorgick ◽  
Yigal Mirovsky ◽  
Yizhar Floman ◽  
Nahshon Rand ◽  
Michael Millgram ◽  
...  

OBJECTIVEThe authors evaluated the long-term clinical outcome of a total posterior arthroplasty system in the surgical treatment of lumbar spinal stenosis with degenerative spondylolisthesis.METHODSBetween June 2006 and July 2007, 10 patients with neurogenic claudication due to spinal stenosis and single-level degenerative spondylolisthesis were enrolled in a nonrandomized prospective clinical study. The patients were evaluated with radiographs and MRI scans, the visual analog scale (VAS) for back and leg pain, the Oswestry Disability Index (ODI), and the SF-36 health survey preoperatively and at 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 7 years, and 11 years postoperatively.RESULTSThe mean VAS score for leg pain dropped from 83.5 before surgery to 13 at 6 weeks and 17 at 11 years after surgery. The mean VAS score for back pain dropped from 56.2 preoperatively to 12.5 at 6 weeks and 14 at 11 years after surgery. The mean ODI score decreased from 49.1 preoperatively to 13.5 at 6 weeks and 16 at 11 years after surgery. MRI at 11 years demonstrated stenosis adjacent to the stabilized segment in one patient. This patient was not symptomatic. The authors did not find evidence of progression of the spondylolisthesis in any of the cases. In one patient, conversion to posterolateral fusion was performed due to an early device malfunction.CONCLUSIONSThe results of this 11-year follow-up study demonstrate that, in patients with spinal stenosis and degenerative spondylolisthesis, decompression and posterior arthroplasty maintain clinical improvement and radiological stability.


1998 ◽  
Vol 16 (2) ◽  
pp. 593-602 ◽  
Author(s):  
J R Berenson ◽  
A Lichtenstein ◽  
L Porter ◽  
M A Dimopoulos ◽  
R Bordoni ◽  
...  

PURPOSE To determine the efficacy and safety of 21 monthly cycles of pamidronate therapy in patients with advanced multiple myeloma. PATIENTS AND METHODS Patients with stage III myeloma and at least one lytic lesion received either placebo or pamidronate 90 mg intravenously administered as a 4-hour infusion monthly for 21 cycles. At study entry, the patients were stratified according to whether they were to receive first-line (stratum 1) or second-line (stratum 2) antimyeloma chemotherapy. Skeletal events (pathologic fracture, radiation or surgery to bone, and spinal cord compression) and hypercalcemia were assessed monthly. RESULTS The results of the first nine previously reported cycles are extended to 21 cycles. Of the 392 randomized patients, efficacy could be evaluated in 198 who received pamidronate and 179 who received placebo. After 21 cycles, the proportion of patients who developed any skeletal event was lower in the pamidronate-group (P = .015). The mean number of skeletal events per year was less in the pamidronate-group (1.3) than in placebo-treated patients (2.2; P = .008). Although survival was not different between the pamidronate-treated group and placebo patients overall, stratum 2 patients who received pamidronate lived longer than those who received placebo (14 v 21 months, P = .041). Pamidronate was safe and well tolerated during the 21 cycles of therapy. CONCLUSION Long-term monthly infusions of pamidronate as an adjunct to chemotherapy are superior to chemotherapy alone in reducing skeletal events in stage III multiple myeloma patients, and may improve the survival of patients on salvage therapy.


Blood ◽  
2004 ◽  
Vol 103 (9) ◽  
pp. 3282-3286 ◽  
Author(s):  
Claire E. Farel ◽  
Doreen G. Chaitt ◽  
Barbara K. Hahn ◽  
Jorge A. Tavel ◽  
Joseph A. Kovacs ◽  
...  

Abstract Studies establishing that intermittent subcutaneous interleukin-2 (IL-2) therapy can lead to substantial CD4 cell increases in many HIV-infected patients have generally been of limited duration. We studied 77 patients participating in active longitudinal studies of subcutaneous IL-2 therapy at our center in order to determine the long-term feasibility of this approach. Following initial induction, patients in each trial were eligible to receive intermittent 5-day cycles of subcutaneous IL-2 treatment at individualized doses and frequencies capable of maintaining CD4 counts at postinduction levels. The mean duration of study participation to date is 5.9 years (range, 1.0-9.3 years). Mean baseline CD4 cell count and CD4 percent values of 0.521 × 109/L (521 cells/μL) and 27% have risen to 1.005 × 109/L (1005 cells/μL) and 38%, respectively, at 90 months. The mean number of subcutaneous IL-2 cycles required to achieve and maintain these increases was 10 cycles (range, 3-29 cycles), and the current mean interval of cycling required to maintain these elevations is 39 months (median, 35 months; range, 2-91 months). We conclude that subcutaneous IL-2 therapy is capable of maintaining CD4 cell increases for an extended period using a remarkably low frequency of intermittent cycling. These observations may contribute to patients' acceptance of subcutaneous IL-2 as a favorable long-term treatment strategy. (Blood. 2004;103:3282-3286)


2000 ◽  
Vol 5 (4) ◽  
pp. 312-325 ◽  
Author(s):  
Gadi Maoz ◽  
Daniel Stein ◽  
Sorin Meged ◽  
Larisa Kurzman ◽  
Joseph Levine ◽  
...  

Psychopharmacological interventions for managing aggression in schizophrenia have thus far yielded inconsistent results. This study evaluates the antiaggressive efficacy of combined haloperidol-propranolol treatment. Thirty-four newly admitted schizophrenic patients were studied in a controlled double-blind trial. Following a 3-day drug-free period and 7 days of haloperidol treatment, patients were randomly assigned to receive either haloperidol-propranolol or haloperidol-placebo for eight consecutive weeks. Doses of medications were adjusted as necessary; biperiden was administered if required. Rating scales were applied to assess aggression, anger, psychosis, depression, anxiety and extrapyramidal symptoms. The mean daily dose of haloperidol was 21 mg (SD = 6.4) in the research group and 29 mg (SD = 6.9) in the controls. Mean and maximal daily doses of propranolol were 159 mg (SD = 61) and 192 mg (SD = 83), and of placebo, 145 mg (SD = 50) and 180 mg (SD = 70), respectively. Compared with the controls, the scores for the research patients decreased significantly from baseline, particularly after 4 weeks of treatment, for some dimensions of anger, psychosis, anxiety, and neuroleptic-induced parkinsonism. A tendency for reduced aggression was shown in the combined haloperidol-propranolol group for some dimensions but not others. These patients also required significantly less biperiden. The tendency toward elevated antiaggressive effect of combined haloperidol-propranolol treatment compared to haloperidol alone may be explained by a simultaneous decrease in aggression, psychotic symptomatology, and anxiety.


2001 ◽  
Vol 40 (04) ◽  
pp. 107-110 ◽  
Author(s):  
B. Roßmüller ◽  
S. Alalp ◽  
S. Fischer ◽  
S. Dresel ◽  
K. Hahn ◽  
...  

SummaryFor assessment of differential renal function (PF) by means of static renal scintigraphy with Tc-99m-dimer-captosuccinic acid (DMSA) the calculation of the geometric mean of counts from the anterior and posterior view is recommended. Aim of this retrospective study was to find out, if the anterior view is necessary to receive an accurate differential renal function by calculating the geometric mean compared to calculating PF using the counts of the posterior view only. Methods: 164 DMSA-scans of 151 children (86 f, 65 m) aged 16 d to 16 a (4.7 ± 3.9 a) were reviewed. The scans were performed using a dual head gamma camera (Picker Prism 2000 XP, low energy ultra high resolution collimator, matrix 256 x 256,300 kcts/view, Zoom: 1.6-2.0). Background corrected values from both kidneys anterior and posterior were obtained. Using region of interest technique PF was calculated using the counts of the dorsal view and compared with the calculated geometric mean [SQR(Ctsdors x Ctsventr]. Results: The differential function of the right kidney was significantly less when compared to the calculation of the geometric mean (p<0.01). The mean difference between the PFgeom and the PFdors was 1.5 ± 1.4%. A difference > 5% (5.0-9.5%) was obtained in only 6/164 scans (3.7%). Three of 6 patients presented with an underestimated PFdors due to dystopic kidneys on the left side in 2 patients and on the right side in one patient. The other 3 patients with a difference >5% did not show any renal abnormality. Conclusion: The calculation of the PF from the posterior view only will give an underestimated value of the right kidney compared to the calculation of the geometric mean. This effect is not relevant for the calculation of the differntial renal function in orthotopic kidneys, so that in these cases the anterior view is not necesssary. However, geometric mean calculation to obtain reliable values for differential renal function should be applied in cases with an obvious anatomical abnormality.


1987 ◽  
Vol 57 (01) ◽  
pp. 55-58 ◽  
Author(s):  
J F Martin ◽  
T D Daniel ◽  
E A Trowbridge

SummaryPatients undergoing surgery for coronary artery bypass graft or heart valve replacement had their platelet count and mean volume measured pre-operatively, immediately post-operatively and serially for up to 48 days after the surgical procedure. The mean pre-operative platelet count of 1.95 ± 0.11 × 1011/1 (n = 26) fell significantly to 1.35 ± 0.09 × 1011/1 immediately post-operatively (p <0.001) (n = 22), without a significant alteration in the mean platelet volume. The average platelet count rose to a maximum of 5.07 ± 0.66 × 1011/1 between days 14 and 17 after surgery while the average mean platelet volume fell from preparative and post-operative values of 7.25 ± 0.14 and 7.20 ± 0.14 fl respectively to a minimum of 6.16 ± 0.16 fl by day 20. Seven patients were followed for 32 days or longer after the operation. By this time they had achieved steady state thrombopoiesis and their average platelet count was 2.44 ± 0.33 × 1011/1, significantly higher than the pre-operative value (p <0.05), while their average mean platelet volume was 6.63 ± 0.21 fl, significantly lower than before surgery (p <0.001). The pre-operative values for the platelet volume and counts of these patients were significantly different from a control group of 32 young males, while the chronic post-operative values were not. These long term changes in platelet volume and count may reflect changes in the thrombopoietic control system secondary to the corrective surgery.


1991 ◽  
Vol 65 (03) ◽  
pp. 263-267 ◽  
Author(s):  
A M H P van den Besselaar ◽  
R M Bertina

SummaryIn a collaborative trial of eleven laboratories which was performed mainly within the framework of the European Community Bureau of Reference (BCR), a second reference material for thromboplastin, rabbit, plain, was calibrated against its predecessor RBT/79. This second reference material (coded CRM 149R) has a mean International Sensitivity Index (ISI) of 1.343 with a standard error of the mean of 0.035. The standard error of the ISI was determined by combination of the standard errors of the ISI of RBT/79 and the slope of the calibration line in this trial.The BCR reference material for thromboplastin, human, plain (coded BCT/099) was also included in this trial for assessment of the long-term stability of the relationship with RBT/79. The results indicated that this relationship has not changed over a period of 8 years. The interlaboratory variation of the slope of the relationship between CRM 149R and RBT/79 was significantly lower than the variation of the slope of the relationship between BCT/099 and RBT/79. In addition to the manual technique, a semi-automatic coagulometer according to Schnitger & Gross was used to determine prothrombin times with CRM 149R. The mean ISI of CRM 149R was not affected by replacement of the manual technique by this particular coagulometer.Two lyophilized plasmas were included in this trial. The mean slope of relationship between RBT/79 and CRM 149R based on the two lyophilized plasmas was the same as the corresponding slope based on fresh plasmas. Tlowever, the mean slope of relationship between RBT/79 and BCT/099 based on the two lyophilized plasmas was 4.9% higher than the mean slope based on fresh plasmas. Thus, the use of these lyophilized plasmas induced a small but significant bias in the slope of relationship between these thromboplastins of different species.


2018 ◽  
Vol 4 (4) ◽  
pp. 519-522
Author(s):  
Jeyakumar S ◽  
Jagatheesan Alagesan ◽  
T.S. Muthukumar

Background: Frozen shoulder is disorder of the connective tissue that limits the normal Range of motion of the shoulder in diabetes, frozen shoulder is thought to be caused by changes to the collagen in the shoulder joint as a result of long term Hypoglycemia. Mobilization is a therapeutic movement of the joint. The goal is to restore normal joint motion and rhythm. The use of mobilization with movement for peripheral joints was developed by mulligan. This technique combines a sustained application of manual technique “gliding” force to the joint with concurrent physiologic motion of joint, either actively or passively. This study aims to find out the effects of mobilization with movement and end range mobilization in frozen shoulder in Type I diabetics. Materials and Methods: 30 subjects both male and female, suffering with shoulder pain and clinically diagnosed with frozen shoulder was recruited for the study and divided into two groups with 15 patients each based on convenient sampling method. Group A patients received mobilization with movement and Group B patients received end range mobilization for three weeks. The outcome measurements were SPADI, Functional hand to back scale, abduction range of motion using goniometer and VAS. Results: The mean values of all parameters showed significant differences in group A as compared to group B in terms of decreased pain, increased abduction range and other outcome measures. Conclusion: Based on the results it has been concluded that treating the type 1 diabetic patient with frozen shoulder, mobilization with movement exercise shows better results than end range mobilization in reducing pain and increase functional activities and mobility in frozen shoulder.


1966 ◽  
Vol 51 (1) ◽  
pp. 63-70 ◽  
Author(s):  
P. F. Roe ◽  
D. M. Mitchell ◽  
G. W. Pennington

ABSTRACT Adrenocortical function was assessed in 20 patients receiving long-term corticosteroid drugs for a variety of non-endocrine disorders. In all cases plasma 17-hydroxycorticosteroids (17-OHCS) levels were within or above normal limits 48 hours after abruptly stopping their drugs and a further marked rise occurred in 7 patients given metyrapone for 24 h. Urinary 17-OHCS excretion did not show a parallel rise. Taking the group as a whole, a small rise in the mean output occurred 48 hours after stopping therapy, and a further slightly greater rise followed metyrapone. 3 patients had a relapse of their underlying condition during the test in spite of normal plasma and urinary 17-OHCS levels.


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