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

OBJECTIVE: To evaluate the prakrti 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. Prakrti assessment with a 24-item questionnaire was performed and depending on the scores the patients were categorized into vata predominant, pitta predominant, and kapha predominant prakrti. 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 vata and pitta predominant prakrti each while six patients had kapha predominant prakrti. IBS-C was diagnosed in 24 patients, IBS-D in 21, and IBS-M in five patients. In vata 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 vata, pitta, and kapha predominant group, respectively. CONCLUSION: Majority of the vata 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 prakrti examination in IBS helps in detecting the proneness of developing an IBS subtype and predicting their QOL accordingly.

Evaluation of package inserts of Ayurveda drug formulations from Mumbai city.

INTRODUCTION: Package insert (PI) is a vital document accompanying a prescribed medication to provide information to the prescriber and end-user at a glance. Studies regarding PIs of Ayurvedic medicines in accordance with standard guidelines are lacking. AIM: Present study was undertaken to evaluate PI of Ayurveda drugs. MATERIALS AND METHODS: PIs of Ayurveda drugs were obtained from five randomly selected Ayurveda medical shops located in three main zones of Mumbai. From each medical shop, a range of 15-20 PI was planned to be collected for different formulations. It was decided to collect a minimum fifty PIs/group for equitable distribution of various formulations in period of January-June2013. Checklist was prepared, and content validity was achieved. Final validated checklist contained a total of 13 items, and the presence or absence of information pertaining to these items on the PI was evaluated. Any other additional information present on PI was also noted. Each item was analyzed and expressed as percentages. RESULTS: The information on 258 PIs included: Name of ingredients (67%), quantity of ingredients (47.27%), route of administration (86.8%), dosage form (86.8%), indications (18%), dose (18%), contraindications (18%), side effects (9%), shelf life (5.81%), storage conditions (11%), and manufacturers name with contact details (34%). CONCLUSION: PIs accompanying Ayurveda medicinal products in India are deficient in information required to be furnished by them.

Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers.

Ashwagandha (Withania somnifera) (WS), a "rasayana" drug, is recommended for balavardhan and mamsavardhan. The study was intended to evaluate dose-related tolerability, safety, and activity of WS formulation in normal individuals. The design was prospective, open-labeled, variable doses in volunteers. Eighteen apparently healthy volunteers (12M:6F, age:18-30 years, and BMI: 19-30) were enrolled. After baseline investigations, they received WS capsules (Rx) (aqueous extract, 8:1) daily in two divided doses with increase in daily dosage every 10 days for 30 days (750 mg/day ×10 days, 1 000 mg/day × 10 days, 1 250 mg/day × 10 days). Volunteers were assessed for symptoms/signs, vital functions, hematological and biochemical organ function tests. Muscle activity was measured by hand grip strength, quadriceps strength, and back extensor force. Exercise tolerance was determined using cycle ergometry. Lean body weight and fat% were computed from skin fold thickness measurement. Adverse events were recorded, as volunteered by the subjects. Repeated measures ANOVA, McNemar's test, and paired t test were employed. All but one volunteer tolerated WS without any adverse event. One volunteer showed increased appetite, libido, and hallucinogenic effects with vertigo at the lowest dose and was withdrawn from study. In six subjects, improvement in quality of sleep was found. Organ function tests were in normal range before and after the intervention. Reduction in total- and LDL- cholesterol and increase of strength in muscle activity was significant. Total body fat percentage showed a reduction trend. WS, in escalated dose, was tolerated well. The formulation appeared safe and strengthened muscle activity. In view of its traditional Rasayana use, further studies are planned to evaluate potential of this drug in patients of sarcopenia.