Health Condition 1: K638- Other specified diseases of intestine
Conditions
Interventions
Intervention1: Intervention group: Patients will receive 400 ml of coconut water daily (250 mg potassium/100 ml) in addition to oral 5-ASA (2.4-3.6 gm/day) for 8 weeks. In a previous study patients in
Sponsors
Dept of Gastroenterology
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who are confirmed cases of mild ulcerative colitis (of any disease extent) as assessed by Mayo score (4-6), within 1 week of relapse 2.Age: 18 â?? 70 years of either gender 3.Patients on stable dose of mesalamine for past 4 weeks 4.Patients on stable dose of azathiopurine/ 6-mercaptopurine for past 6 months 5.Ready to participate
Exclusion criteria
Exclusion criteria: 1.H/O of oral steroids in the past 4 weeks 2.H/O or oral antibiotics within past 2 weeks 3.H/O topical therapy within 1 week 4.Patients with severe disease activity 5.Patients with fulminant colitis requiring hospitalization 6.Patients who have had surgery 7.Patients with Crohnâ??s colitis 8.Patients with concomitant GI infection 9.Patients on drugs that can affect potassium homeostasis (ACE-inhibitors, angiotensin receptor blockers, aldosterone antagonists) 10.Patients with comorbidities like acute myocardial infarction, chronic kidney disease or chronic liver disease or any other condition which precludes high potassium diet 11.Patients with significant hepatic, renal, endocrine, respiratory, neurologic, or cardiovascular diseases will also be excluded 12.Pregnant, lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Clinical remission at 8 weeks, defined as Mayo score â?¤2 with all sub-scores â?¤1.Timepoint: at 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Clinical response at 8 weeks, defined as reduction in Mayo score by more than 3 points or by 30 percent reduction in Mayo score from baseline. 2.Treatment failure, defined as increase in Mayo score by more than 3 points with all sub scores more than 1. 3.Adverse events at 8 weeks Timepoint: At 8 weeks | — |
Countries
India
Contacts
Public ContactDrVineet Ahuja
All India Institute of medical Sciences
Outcome results
None listed