None listed
Conditions
Brief summary
Irritable bowel syndrome (IBS) is the most common gastrointestinal disorder without any physical or physiological abnormality affecting approximately 10% of the population of Western countries. IBS is largely diagnosed in early adulthood and though the degree to which people are affected differs, IBS can cause significant impact of lifestyle, relationships and productivity. Kivia (Trademark) Zyactinase (Registered Trademark) is a 100% natural freeze-dried kiwifruit product which has been tested in both animals and humans and shown to be safe Kivia (Trademark) is manufactured in New Zealand and is commercially available in Australia. The purpose of this Phase III study is to see whether the product Kivia (Trademark) containing the active ingredient Zyactinase (Registered Trademark) can provide relief of IBS associated constipation and other symptoms of IBS. Subjects diagnosed with constipation dominant IBS will be randomised in a 1:1 ratio to receive either Kivia (Trademark) or matched placebo capsules for eight weeks Daily information about IBS-C symptoms will be captured by subjects using an electronic diary, and they will attend six clinic visits for efficacy and safety assessments.
Interventions
Treatment Arm 1: Oral capsules of Zyactinase (Registered Trademark) (active ingredient ) 1150mg , twice daily for four weeks followed by 575mg twice daily for four weeks. Total treatment period is 8 weeks
Treatment Arm 2:Oral capsules of placebo 1150mg twice daily for four weeks followed by 575mg twice daily for four weeks. Total treatment period is 8 weeks.
Study drug will be administered at the beginning of each dose period and all unused medications and used packaging is to be returned a
Treatment Arm 1: Oral capsules of Zyactinase (Registered Trademark) (active ingredient ) 1150mg , twice daily for four weeks followed by 575mg twice daily for four weeks. Total treatment period is 8 weeks Treatment Arm 2:Oral capsules of placebo 1150mg twice daily for four weeks followed by 575mg twice daily for four weeks. Total treatment period is 8 weeks. Study drug will be administered at the beginning of each dose period and all unused medications and used packaging is to be returned at the end of each dose period.
Sponsors
Vital Food Processors Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Subjects diagnosed with IBS-C according to Rome III criteria Abdominal pain intensity in past 24 hour score of >3.0 using VAS scale during screening Subject swith Fewer than 3 Complete Spontaneous Bowel Movements per week during screening
Exclusion criteria
Diarrhoea predominant or alternating IBS Significant GI condition or serious systemic illness
Outcome results
None listed