Efficacy and acceptability of pomegranate effervescent granules in patients suffering from acid peptic disorders.

CONTEXT: Acid peptic disorders. AIMS: This study aimed to assess the efficacy and acceptability of pomegranate effervescent granules (PEGs) in dyspeptic patients. SETTINGS AND DESIGN: It was a single-arm, open-labeled prospective multicentric clinical study, done at 3 centers: Vishwanand Kendra, Pune; Bharati Ayurved Hospital, Bharati Vidyapeeth, Pune, and M. A. Podar Medical Ayurved Hospital, Mumbai. The co-ordinating site was Interactive Research School for Health Affairs, Bharati Vidyapeeth, Pune. MATERIALS AND METHODS: The granules, prepared from peel extract of pomegranate, were made available in sachets of 2.5 g with dose of, 1 sachet dissolved in 200 ml (1 cup) of water, twice a day after meals for 28 days. Gastrointestinal Symptom Rating Scale (GSRS) scores to assess symptoms of acid peptic disorders at day 0, 15, and 29 along with the taste of formulation were the main study outcomes. STATISTICAL ANALYSIS USED: Parametric data, presented as mean ± standard deviation, were analyzed using paired t-test, while nonparametric data presented as median (range) was analyzed using Wilcoxon rank-sum test. Categorical data were analyzed using Chi-square test. RESULTS: The median GSRS score reduced from 14 on day 0-10 and then 5 on day 15 and day 29, respectively, with statistical significance. The formulation was found to taste good by ~80% of patients, while ~20% reported it to be palatable and none found it to be bad in taste. CONCLUSION: PEGs proved to be palatable, patient-friendly, safe, and efficacious in resolving symptoms of dyspepsia in acid peptic disorders. CTRI Registration: The trial was registered retrospectively in the Clinical Registry of India [CTRI/2017/07/008999].

Evaluation of the efficacy and safety of Capsule Longvida® Optimized Curcumin (solid lipid curcumin particles) in knee osteoarthritis: a pilot clinical study.

Purpose: Osteoarthritis is the single most common cause of disability in older adults with an estimated 10% to 15% prevalence in individuals above 60 years. The contemporary medications include nonsteroidal anti-inflammatory drugs acetaminophen, cyclooxygenase-2 inhibitors, and surgical interventions. In view of safety issues regarding their longterm use, necessitating search for effective and safe alternatives, we evaluated Capsule Longvida® Optimized Curcumin prepared using solid lipid curcumin particles (SLCP) technology in patients with knee osteoarthritis. Patients and methods: Eligible patients fulfilling American College of Rheumatology Criteria were randomized to SLCP group (400 mg twice daily delivering 80 mg of curcumin per capsule) or Ibuprofen with placebo group (400 mg each once daily) for 90 days. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Visual Analog Scale (VAS) were used for clinical assessment of knee pain and function. Degree of knee flexion and swelling were also noted. Blood biochemistry included hemogram, blood urea, creatinine, Random blood sugar and inflammatory markers viz. PGE2, TNF α, IL6, IL1ß and LTB4 while urine examination included degenerative marker CTX II. The parametric data was analyzed using unpaired t test while non-parametric data was analyzed using Friedman's test or Mann Whitney t test as applicable. A level of p<0.05 was considered as statistically significant. Results: Out of 50 recruitments, 25 from the Ibuprofen group and 17 from the SLCP group completed the study with significant improvements in VAS and WOMAC scores indicating comparable efficacy of SLCP in alleviating pain with Ibuprofen. None of the markers displayed significant changes. Except one withdrawal in the study group due to rash and itching, the study drug was found safe. Conclusions: SLCP in a dose of 160 mg daily was found to be effective and safe in alleviating symptoms in patients suffering from knee osteoarthritis when administered for 90 days.