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

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 distension 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 hardstool formation, feeling of incomplete evacuation, feeling of ano-rectal blockage and manual maneuvers (p < 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

Sub chronic oral toxicity study of Janma Ghunti Honey in Wistar rats

The present study was conducted to evaluate the safety profile of Janma Ghunti Honey in Wistar rats on oral administration for 28 consecutive days. Animals were randomized on the basis of body weight into 6 groups. Three groups received test item (TI) at three different dose levels (3 mL/k g, 6 mL/kg and 12 mL/kg body weight). One group served as high dose satellite reversal group (12 mL/kg). One group each served as the control and satellite control group. Animals were observed for clinical signs of toxicity and mortality at least once daily. Animals from satellite groups were observed for further 14 days without treatment to evaluate delayed occurrence or reversibility of any signs/toxicity. At the end of the study, animals were studied through clinical pathology and necropsy examination. No treatment related mortality was observed in any group. Except in female low dose and female high dose satellite groups, all the treated groups exhibited weight gain and no statistically significant alterations were observed. No TI related toxicity was found on hematological investigation, blood biochemistry parameters and absolute and relative organ weights among treated groups. 'No Observed Adverse Effect Level' of TI in male and female Wistar rats was found to be above 12 mL/kg body weight

Clinical evaluation of efficacy and safety of appetizer syrup as appetite stimulant in children with non-pathogenic anorexia

700-705Anorexia, i.e., lack of desire to eat or loss of appetite is a common cause of parental concern in pre-school and school-going children. Many herbs and herbal formulations have been traditionally used in India as ‘appetizers’ in children with non-pathological anorexia and over 100 phyto-constituents are claimed to have appetite-stimulant effects, though efficacy and safety of many of these formulations needs to be evaluated with well-controlled clinical trials. Appetizer syrup (Mfd: Dabur India Limited) is an Ayurvedic polyherbal formulation proposed to stimulate appetite in children with non-pathogenic anorexia. It comprises herbs such as Kismis (Vitis vinifera L.), Pipalli (Piper longum L.), Anar (Punica granatum L.), Amla (Emblica officinalis Gaertn), etc., that are traditionally known to be useful in digestive impairment and are documented to possess appetite stimulant and strength promoting properties. Present trial was a double-blind, randomized, placebo-controlled parallel group clinical study to evaluate the efficacy and safety of Appetizer Syrup in children with non-pathogenic anorexia. Results were assessed from baseline to study completion on basis of the appetite stimulating effects of the formulation and the benefits secondary to appetite stimulation like changes in anthropometric measurements and academic performance

Evaluation of antioxidant, immunostimulatory and antifatigue properties of <em>Dashmularishta</em> using <em>in vitro</em> and <em>in vivo</em> assays

598-603Dashmularishta is an Ayurvedic formulation used widely as a health tonic. Since the mode of action of Dashmularishta has not been explored much in detail so far, we investigated its potential effects on antioxidant, antifatigue and immunostimulatory properties using in vitro as well as in vivo assays. The antioxidant potential was assessed by free radical scavenging (ABTS based) assay. Antifatigue potential was elucidated by DNA super coiling assay and swim endurance test model. Immunostimulatory effect on Natural Killer (NK) cells activity was evaluated using mouse splenocytes and YAC-1 based assay. Dashmularishta exhibited in vitro antioxidant and antifatigue potential and in vivo anti-fatigue properties in Swiss albino mice. Further, it also enhanced the in vitro NK cells activity at noncytotoxic concentrations

Evaluation of immunostimulatory activity of Chyawanprash using <i style="mso-bidi-font-style:normal">in vitro </i>assays<i style="mso-bidi-font-style:normal"><span style="font-size:11.0pt; mso-bidi-font-size:10.0pt" lang="EN-GB"></span></i>

158-163Chyawanprash is an ayurvedic formulation used in Indian traditional medicinal system for its beneficial effect on human health. We investigated the immunostimulatory effects of Chyawanprash (CHY) using in vitro assays evaluating the secretion of cytokines such as Tumor Necrosis Factor-alpha (TNF-α), Interleukin-1beta (IL-1β) and Macrophage Inflammatory Protein-1-alpha (MIP-1-α) from murine bone marrow derived Dendritic Cells (DC) which play pivotal role in immunostimulation. The effects of CHY on phagocytosis in murine macrophages (RAW264.7) and Natural Killer (NK) cell activity were also investigated. At non-cytotoxic concentrations (20–500 µg/ml), CHY enhanced the secretion of all the three cytokines from DC. CHY also stimulated both, macrophage (RAW264.7) as well as NK cell activity, in vitro. In conclusion, the data substantiates the immunoprotective role of CHY at cellular level mediated by immunostimulation in key immune cells viz. dendritic Cells, macrophages and NK cells