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Lalla J.K.,Mayfair Clinical Education and Research Center | Shah M.U.,Mayfair Clinical Education and Research Center
International Journal of Pharma and Bio Sciences | Year: 2010

Objective: The objective of this study was to assess the toxic effects of Oxy powder® in-vitro on four pathogenic microbes and a probiotic bacterium generally present in the human GI tract and to determine acute oral toxicity (LD50) profile of Oxy Powder® in Sprague Dawley rats. The results shall be used in selecting doses in repeated dose toxicity study of Oxy Powder Background: (A) In Vitro Toxicity Study in Selected Microbial Cultures: Host of plants, large number of drugs and few Nutraceuticals are reported to act as antimicrobial agents. Oxy powder®, a dietary supplement is used in patients suffering from chronic constipation and/or IBS; it may have antimicrobial action. This aspect has been experimentally assessed in vitro in selected microbes since it is extremely difficult to assess this in in vivo studies. Guidelines followed: Schedule Y in Drugs and Cosmetic Act (IInd Amendment) Rules, 2005, Ministry of Health and Family Welfare, Government of India, Study design: The study was designed to include 3 strains of pathogenic bacteria namely E. coli, Staph. aureus and Enterococcus faecalis, a yeast, Candida albicans and one Probiotic organism, Lactobacillus bifidigus. The experimental work performed under sterile conditions involved use of Cup plate technique with positive and negative controls. An Oxy powder® content of one capsule (715.5 mg) was dissolved in 60 mL sterile distilled water; citric acid solution prepared by dissolving 25 mg of the acid in 60 mL sterile distilled water was used as control. Separately, solution of Oxy Powder® and that of citric acid was added to the cups bored in inoculated media at five different intervals namely 0 minute, 15 minutes, 30 minutes, 45 minutes and 60 minutes. The plates were incubated at 37oC for 72-96 hours. The growth was recorded every 24 hours during incubation period. Results & Conclusion: At the given concentration of test substance, the Oxy powder® did not exhibit 'static' or 'cidal' activity against all the cultures employed indicating that Oxy powder® when used in the patients would not kill or inhibit the growth of microbes in GI tract. (B) Acute Oral Toxicity of Oxy Powder in Sprague Dawley Rats: US FDA does not evaluate safety, efficacy and quality of dietary supplement ingredients or products. Consumers often take dietary supplements at their own risk. Potential risks (including use of dietary supplements by children) are involved in the use of these products including contamination, adulteration, and dosage inconsistency. It becomes all the more important to establish safety, quality, effectiveness and tolerability of Oxy Powder®. Guidelines followed: (a) Schedule "Y" in Drugs and Cosmetics Act and Rules, 1988 (IInd Amendment, 2005), Ministry of Health and Family Welfare, Government of India. (b) OECD Guidelines for the Testing of Chemicals (No. 420, Section 4: Health Effects) "Acute Oral Toxicity - Fixed Dose Method" Adopted on 17th December 2001 (c) WHO GCP Guidelines (described in WHO's GLP Handbook) (d) UCSF IACUC POLICY-LABORATORY HOUSING AND STUDY AREAS FOR RESEARCH ANIMALS (May 2001, revised December 2003) Study design: The study was conducted by acclimatizing the animals for five days prior to dosing. They were maintained at temperature between 20 o & 24 oC, relative humidity between 30% and 70%, 10 to 15 air changes per hour and 12 hours each of dark and light cycle. Each dose was administered as an aqueous suspension 'Per OS' at 10 mL/kg body weight In the Sighting study performed in one female rat administered oxy powder at 2000 mg/kg body weight and subsequently 5000 mg/kg body weight in another, the animals survived., The Main study was then conducted at the dose level of 5000 mg/kg body weight in 4 female rats. All four animals survived through the study period of 14 days. End Points: Gross pathological examination did not reveal any abnormalities. Necropsy examination did not reveal any gross abnormality; hence, histopathological examination was not carried out. Conclusion: Thus, Oxy Powder exhibited high degree of safety and the acute oral toxicity of Oxy Powder® in Sprague Dawley rats could be included in "Category 5" criteria of Globally Harmonised System. Source


Lalla J.K.,Mayfair Clinical Education and Research Center | Shah M.U.,Mayfair Clinical Education and Research Center
International Journal of Pharma and Bio Sciences | Year: 2010

Objectives: 1) To assess the Sub-chronic toxicity of Oxy Powder® administered orally to rats for 28 days, 2) To determine (i) Target organ toxicity (ii) "No observed effect level (NOEL)" (iii) Reversibility of signs of toxicity after recovery period. Background: US FDA does not evaluate safety, efficacy and quality of dietary supplement ingredients or products. GHC decided to study safety of Oxy Powder®, a dietary supplement used in Chronic Constipation and IBS. Guidelines followed: (a) OECD Guidelines No. 407, (b) WHO GCP Guidelines (c) UCSF IACUC POLICY (d) Schedule "Y" in Drugs and Cosmetics Rules, (India). Study Design and Controls: 1) Rats of both sexes in controlled age and body weight were selected. 2) Oxy Powder® was administered at 250, 500 and 1000 mg/kg body weight as aqueous suspensions along with a blank 3) The results were recorded on day 0, throughout the dosing period of 28 days and during recovery period of 14 days End Points: 1) Ophthalmoscopic examination on days 0+29, 2) Haematological analysis, biochemical analysis and urine analysis on days 0+29+43. 3) Organ weights, histopathological and gross pathological observations of sacrificed animals recorded after recovery period. Observations: 1) No abnormalities attributable to the treatment with Oxy Powder® 2) No target organ toxicity 3) No reversibility of any signs of toxicity at the end of recovery period of 14 days. Conclusion:NOEL of Oxy Powder(r) administered orally to Sprague Dawley rats for 28 days was found to be 1000 mg/kg body weight for male and female animals. Source


Lalla J.K.,Mayfair Clinical Education and Research Center | Shah M.U.,Mayfair Clinical Education and Research Center | Edward F.,Global Healing Center Inc.
International Journal of Pharma and Bio Sciences | Year: 2010

To conduct a clinical trial for evaluating safety, tolerability and effectiveness of Oxy Powder® (OP) in patients of chronic constipation and Constipation - Predominant IBS. Constipation is the slow movement of feces through the large intestine resulting in the passage of dry, hard stools. Fecal impaction is a collection of dry, hard stool in the colon or rectum. Study Design: 6 weeks open, comparative, randomized study enrolling 40 patients of constipation and 20 of IBS. Trial Formulations: (A) Oxy powder ® (Marketed by Global Healing Center, Inc., USA) - Test Product A. (B) Dulcolax Tablets (DX), [manufactured by Zydus Cadila Ltd, (India)] - Reference Product B. Guidelines followed: (a) Rome criteria (b) GCP described under ICH E6 document (c) World Medical Association's (WMA) Bioethics Declaration of Helsinki. (d) Schedule Y in Drugs and Cosmetic Act and (2nd Amendment) Rules, 2005, Ministry of Health and Family Welfare, Government of India, End Point(s): 1) Recording change in weight 2) The effectiveness of the product for Oxygen delivery in patients 3) Finding of (i) stool examination (ii) Barium Meal X-ray and (iii) Colonoscopy 4) Relief of constipation and IBS. Results and Discussion: There were insignificant changes in weight and blood oxygen levels during treatment in both the Groups. Stool examination did not show abnormality in any patient. Patients in both Groups showed significant reduction in various symptoms including a) straining, (b) passing of lumpy stools(c) sensation of incomplete evacuation & Anorectal Blockage and (e) manual maneuvers to facilitate Bowel movements. Overall Efficacy: In Group A, (out of 26), 11 (42.3%) had complete cure, 15 (57.7%) showed Improvement, In Group B, (out of13), 1 (7.7%) had complete cure,10 (76.9%) showed Improvement with 2 (15.9%) failures. Conclusion: Safety, Efficacy and tolerability of OP in treating constipation was significantly (P<.05) higher than DX. Source


Lalla J.K.,Mayfair Clinical Education and Research Center | Parmar D.V.,Mayfair Clinical Education and Research Center | Shah M.U.,Mayfair Clinical Education and Research Center
International Journal of Pharma and Bio Sciences | Year: 2010

An open, randomized, comparative, Phase II clinical trial on 20 patients with Constipation - Predominant Irritable Bowel Syndrome (IBS-C) was conducted for 6 weeks for evaluating safety, tolerability and efficacy of Oxy Powder® (OP) compared with Dulcolax (DX) tablets. The results indicated that complete cure was obtained in 30.8% and improvement in 69.2% patients treated with OP. In case of DX, improvement was seen in 71.4% patients and failure in 28.6% patients. There was no failure in case of OP indicating that efficacy of OP in treating IBS-C was significantly higher (p<.05) than DX. Source

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