Constipation Study

This summary report has been extracted from the Original Phase I, II, and III active, controlled Clinical Studies on Oxy-Powder®. We tested many components of Oxy-Powder® including acute toxicity, sub-chronic toxicity and anti-bacterial activity. We also tested the effectiveness of Oxy-Powder® for symptoms of chronic constipation, and IBS (Irritable Bowel Syndrome). For ease of reading, we summarized the results of each test.

According to the Rome II criteria for constipation, all patients in the study were suffering from constipation for 12 weeks (3 months) or more.

Summary of Oxy-Powder® Clinical Study for Chronic Constipation

25 of 27 patients (92.6%) had straining during bowel movements on Day 0 as compared to Day 42 when only 2 (7.7%) patients had this symptom. A significant reduction in symptoms was achieved after administration of Oxy-Powder®.
26 of 27 patients (96.3%) passed hard and lumpy stools on Day 0 where as on Day 42 it was reported only in two patients (7.7%). A significant reduction in symptoms was achieved after administration of Oxy-Powder®.
25 of 27 patients (92.6%) had sensation of incomplete evacuation on Day 0 where as on Day 42 it was reported only in 5 (19.2%). A significant reduction in symptoms was achieved after administration of Oxy-Powder®.
15 of 27 patients (55.6%) had sensation of anorectal blockage on Day 0 where as on Day 42 it was reported only in 1 (3.8%). A significant reduction in symptoms was achieved after administration of Oxy-Powder®.
11 of 27 patients (40.7%) had to perform manual manoeuvres to facilitate bowel movements on Day 0 where as by Day 21 it was reported that 0 patients had any further symptoms. A significant reduction in symptoms was achieved after administration of Oxy-Powder®.

**One patient in the Oxy-Powder® administered group of 27 patients had severe diarrhea on the 2nd day of treatment. He could not carry out his usual activities and felt dehydrated; hence he was withdrawn from the study on 3rd day reducing the study population to 26 patients.

Routine stool examination done before and after the drug treatment showed no abnormality in all patients in this study.

Overall Efficacy - Oxy-Powder®
Overall Efficacy was independently judged by the Investigators & the Patients. It was graded as Excellent, Good, Fair, and Poor. The results were statistically analysed using Fisher's Exact Test.
ASSESSMENT- INVESTIGATORS	EXCELLENT	13 - 50.0 %
	GOOD	12 - 46.2 %
	FAIR	1 - 3.8 %
	POOR	0 - 0.0 %
	TOTAL	26 - 100.0 %
ASSESSMENT- PATIENTS DRUG CODE Cross Tabulation	EXCELLENT	12 - 46.2 %
	GOOD	13 - 50.0 %
	FAIR	1 - 3.8 %
	POOR	0 - 0.0 %
	TOTAL	26 - 100.0 %

Investigator Summary:
In the group of 26 patients, Investigator assessment was Excellent for 13 (50%), Good for 12 (46.2%), Fair for 1 (3.8 %), and Poor for none (0.0%). Results indicate Oxy-Powder® was effective in treating constipation and reducing the symptoms associated with constipation according to the Rome II Criteria for diagnosing chronic constipation.

Patient Summary:
In the group of 26 completed patients, the Patient assessment was Excellent for 12 (46.2%), Good for 13 (50%), Fair for 1 (3.8%), and Poor for none (0.0%). Results indicate Oxy-Powder® was effective in treating constipation and reducing the symptoms associated with constipation according to the Rome II Criteria for diagnosing chronic constipation.

Overall Efficacy was also judged as Complete Cure, Improvement, and Failure. Table 14 shows that in Group A (out of 26 patients), 11 patients (42.3%) had Complete Cure, 15 patients (57.7%) had Improvement, and there was no Failure.

Efficacy of Oxy-Powder® in Treating Chronic Constipation
Overall Efficacy was independently judged by the Investigators & the Patients. It was graded as Excellent, Good, Fair, or Poor. The results were statistically analysed using Fisher's Exact Test.
CHANGE OBSERVED	EFFICACY
COMPLETE CURE	11 (42.3 %)
IMPROVEMENT	15 (57.7 %)
FAILURE	0 (0.0 %)
TOTAL	26 (100.0 %)

The final results indicated:

Complete cure: 42.3% patients treated with Oxy-Powder®.

Significant Improvement: 57.7% in patients treated with Oxy-Powder®.

Failure: 0% in patients treated with Oxy-Powder®.

Thus, efficacy of Oxy-Powder® in treating constipation was significant. This indicated Oxy-Powder® was efficacious in treating constipation.

Results Above Indicate Efficacy of Oxy-Powder® is Significant in Treating Patients of Constipation.

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