Evaluation of prakṛti and quality-of-life in patients with irritable bowel syndrome

Objective: To evaluate the prakṛti of irritable bowel syndrome (IBS) patients and its association with IBS subtypes and quality-of-life (QOL). Methodology: IBS patients with the consistent subtype in the last 6 months were recruited. Prakṛti assessment with a 24-item questionnaire was performed and depending on the scores the patients were categorized into vāta predominant, pitta predominant, and kapha predominant prakṛti. QOL was assessed with prevalidated disease-specific 34-item questionnaire scored on a 0-100 scale. Results: Of 50 IBS patients enrolled, with mean age of 43.5 ± 12.8 years, and male: female as 43:7, 22 patients were of vāta and pitta predominant prakṛti each while six patients had kapha predominant prakṛti. IBS-C was diagnosed in 24 patients, IBS-D in 21, and IBS-M in five patients. In vāta predominant group, IBS-C was found in 13 patients, IBS-D in 8, and IBS-M in 1. In pitta predominant group, IBS-D was found in 13, IBS-C in 6, and IBS-M in 3. In kapha predominant group, IBS-C was found in 5 patients and IBS-M in 1. The median QOL in IBS-C group was 48.897, IBS-D was 38.97, and IBS-M was 66.911. The median QOL score 52.205, 42.27, and 55.51 in vāta, pitta, and kapha predominant group, respectively. Conclusion: Majority of the vāta predominant patients had developed IBS-C, pitta predominant patients had developed IBS-D. QOL was better in pitta predominant individuals of all IBS-disease subtypes. With this, we find that prakṛti examination in IBS helps in detecting the proneness of developing an IBS subtype and predicting their QOL accordingly

Evaluation of performance of the Medical Research Department in ′Research naive′ non-academic hospital: An audit

Introduction: Conducting medical research is not limited to academia and pharmaceutical industry but even multispeciality hospitals need to venture in this area along with patient care. To develop research culture among well-established non-acedemic hospital is always difficult and challenging task. This article attempts to evaluate the performance of the department in ′Research naοve′ hospital in the last two years and review the strengths and challenges it faced at each step. Methods: This was a retrospective document analysis study evaluating the steps towards setting and sustaining of Medical Research Department of Bhaktivedanta Hospital during the period of January 2013 to June 2015 (30 Months). The authors developed a checklist (along with performance indicators) to assess the Preparatory phase and Activity phase of the research department which were evaluated by Institute Quality Management Team .Each step of both phases was also reviewed in terms of strengths and challenges as perceived by the authors. Results: During 2 year journey of research naοve Hospital, Institute had witnessed Hospital initiated (n=24, 59%) and sponsored projects (n=17, 41%) in all specialties. HRC reviewed (n=2.13) projects per meeting for administrative consideration while IEC reviewed (n=2.15) projects for scientific and ethical review. Challenges during preparatory phases were circumvent by immense cooperation of hospital management for initial investment, sensitization through research workshops for consultants, established procedures and trained support manpower and constant encouragement by research coordinator. Conclusion: Considering evaluation of 41 studies in very first 2 years in ′Research naive non academic institute demonstrated successful implementation of trio model of Hospital Research Committee for administrative review, IEC for scientific-ethical review, centralized MRD for coordinating all research projects under one roof which may act as role model for Research naive institute

Efficacy and Safety Evaluation of Myostaal Forte, a Polyherbal Formulation, in Treatment of Knee Osteoarthritis: A Randomised Controlled Pilot Study

Introduction: Myostaal Forte, a proprietary poly-herbal formulation, is mixture of nine herbal plant extracts which possess analgesic, anti-inflammatory and chondroprotective properties. Aim: A prospective, randomised, active controlled, 2-arm, parallel group, assessor blind study was planned to evaluate clinical efficacy and safety of Myostaal Forte in patients of knee osteoarthritis. Materials and Methods: Idiopathic knee osteoarthritis cases as per American College of Rheumatology (ACR) clinical criteria were screened and recruited. A total of sixty patients were assigned to receive Myostaal Forte TDS (n=30) or Paracetamol 650 mg TDS (n=30) for six weeks. Naproxen was rescue analgesia. Modified Western Ontario and McMaster Universities Arthritis Index (WOMAC), Visual Analogue Scale (VAS), global assessment scores determined by orthopaedic physician at baseline, two, four, six weeks and telephonically at eight weeks. Safety was assessed through laboratory investigations at baseline and six weeks, adverse events and tolerability. Data were expressed as Mean±SD and analysed by Chi-square and unpaired t-test. p<0.05 was considered significant. Results: Myostaal Forte and Paracetamol showed significant reduction in osteoarthritis disease activity. Myostaal Forte produced significant improvement compared to Paracetamol, in the pain, stiffness and physical function from baseline to eight weeks (p0.05). No significant adverse events, changes in the laboratory parameters and excellent compliance to treatment were seen in both the groups. Conclusion: Earlier onset analgesic effect with sustained chondroprotection after treatment cessation makes Myostaal Forte, a safe and effective alternative for treatment of knee osteoarthritis

An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital.

Protocol deviations (PDs) may jeopardize safety, rights, and welfare of subjects and data integrity. There is scarce literature and no guidelines for Institutional Ethics Committees (IECs) to process PD reports. The PD reports submitted to IECs from Jan 2011 to August 2014 were analyzed retrospectively. Types of studies reporting PDs, category and type of PDs, PD rate per participant, time of reporting PD since its occurrence and corrective actions stated by principal investigator (PI) for major deviations were noted. Out of 447 PDs from 73/1387 total studies received during study period, 402 were from 126 pharma studies. Investigator initiated studies and dissertations reported negligible PDs. Median number of PDs was 4 per protocol. Out of 447 PDs, 304 were related to study procedure, 87, 47 and 9 were from safety, informed consent document (ICD) and eligibility category respectively. The most common reason for PDs was incomplete ICD (22/47). Maximum study procedure related PDs were due to patient visiting outside window period (126/304). Thirty five of 87 PDs were due to missed safety assessment. The overall PD reporting rate per participant was 0.08. In 90% of reports, date of occurrence of PD was not specified. The median delay for reporting PDs after occurrence was 94 days. PDs classified as Major were 73% (323/447). The most common corrective actions stated by PI were participant counseling (85/323) and caution in future (70/323). The study findings emphasize the need for GCP training at regular interval of study team members. IEC have to be vigilant and visit sites frequently, take initiative and formulate guidelines regarding PD reporting

Distribution of major and minor deviations for the study procedure category.

<p>Distribution of major and minor deviations for the study procedure category.</p

Distribution of PDs according to different categories.

<p>Distribution of PDs according to different categories.</p

Major and minor deviations for each study type.

<p>Major and minor deviations for each study type.</p