Comparative, Randomized, Phase II Clinical Trial of in the treatment of patients with acute Diarrhea
- Conditions
- Health Condition 1: null- Acute diarrheaHealth Condition 2: R197- Diarrhea, unspecified
- Registration Number
- CTRI/2010/091/000142
- Lead Sponsor
- nique Biotech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
1.Adults with acute diarrhoea having > 3 loose stools in last 24 hours, having diarrhoea < 7 Days.
2.Patients with no major illness.
3.Patients willing to give written informed Consent & willing to follow up.
1.Mucous stools or bleeding per rectum
2.Subjects taking any other medications like anticoagulants, beta-blockers, diuretics, and steroids etc., which have potential effects on lipoprotein regulation mechanisms.
3.Subjects with the recent history of cardiovascular diseases like MI or who have undergone angioplasties, coronary bypass surgery or any other documented morbidity from atherosclerotic vascular diseases within the last 6 months of enrollment.
4.Subjects with past history of any debilitating neurological disorders, severe depression.
5.Clinical signs of severe dehydration, clinical signs of coexisting acute systemic illnesses (meningitis, sepsis, pneumonia), immunodeficiency, underlying severe chronic diseases, cystic fibrosis,
6.Food allergy or other chronic gastrointestinal diseases,
7.Use of probiotics in the previous three weeks, use of antibiotics or any antidiarrhoeal medication in the previous three weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Duration of Diarrhea <br/ ><br>2.Frequency of Diarrhea <br/ ><br>Timepoint: 10 days
- Secondary Outcome Measures
Name Time Method 1.Rescue medication <br/ ><br>2.Safety Assessment <br/ ><br>3.Clinical Global Assessment by Investigator on liken scale <br/ ><br>4.Patients Self Assessment <br/ ><br>Timepoint: 10 days