CTRI/2010/091/000142CompletedPhase 2
An Open Label, III Arm, Comparative, Randomized, Phase II Clinical Trial Of Probiotic Strains Saccharomyces Boulardii, Bacillus Coagulans And Bacillus Clausii In The Treatment Of Patients With Acute Diarrhea
nique Biotech Limited0 sites75 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 75
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
Similar Trials
Recruiting
Not Applicable
ow Protein Diet Supplementation Study in Non-Diabetic Kidney Disease PatientsCTRI/2017/03/008246Dr Pratim Sengupta
Recruiting
Phase 2
Comparator study with Standard of care treatment and Investigational product (HAVR-122008) in Uncomplicated Respiratory Viral Infection.CTRI/2021/03/032446The Himalaya Drug Company
Completed
Phase 2
Clinical study on Turmeric mouth wash in the treatment of Oral ulcers due to cancer therapy.CTRI/2018/03/012371The Himalaya Drug Company45
Completed
Phase 3
To compare the efficacy and safety of Diclofenac 25 mg + paracetamol 325 mg FDC vs. Aceclofenac 100mg in the management of osteoarthritisCTRI/2010/091/000076Troikaa Pharmaceuticals Limited150
Completed
Phase 4
To compare the efficacy and safety of Oral Trans-Mucosal Fentanyl Citrate vs. oral morphine in patients with break through cancer pain.CTRI/2010/091/001179Troikaa Pharmaceuticals Limited200