CTRI/2019/11/022190
Completed
未知
A randomized, double-blind, placebo-controlled, parallel study, to evaluate the safety and efficacy of Boswellia serrata extract 200 mg capsules of Inventia Healthcare Limited in subjects with Irritable Bowel Syndrome (IBS) - NA
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Inventia Healthcare Limited
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must be able to provide voluntary written informed consent and to follow protocol requirements
- •Male and female subjects aged between 18 to 65 years both inclusive
- •Subjects diagnosed with IBS as per Rome 4 criteria at the time of screening. Rome 4 Diagnostic Criteria includes
- •Recurrent abdominal pain on average at least 1 day per week in the last 3 months associated with two or more of the following
- •Related to defecation
- •Associated with a change in frequency of stool
- •Associated with a change in form appearance of stool
- •Note Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
- •Willingness to complete subject diaries and respond to study questionnaires
- •Women of childbearing potential (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing two acceptable methods of contraception
Exclusion Criteria
- •The subjects must not meet any of the following exclusion criteria:
- •1\.Hypersensitivity to any of the components of Boswellia serrata extract or any of the ingredients of the formulations.
- •2\.Gastrointestinal bacterial infection or parasite infestation
- •3\.History of major gastrointestinal surgery
- •4\.History of intolerance/ allergy to any food items
- •5\.Any intervention for IBS in the period of last 4 weeks
- •6\.History or presence of carcinoma colon or ulcerative colitis
- •7\.Pregnant or lactating women
- •8\.History or presence of any uncontrolled debilitating systemic disease (including but not limited to cardiovascular disease, hypertension, diabetes mellitus type I and II, chronic liver disease including cirrhosis, chronic kidney disease etc.)
- •9\.Subjects with major surgical procedure (including periodontal) within 28 days prior to the first dose of Investigational Product.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapsesMultiple sclerosisMedDRA version: 12.0Level: PTClassification code 10028245Term: <Manually entered code. Term in E.1.1>EUCTR2004-000555-42-DKSanofi-aventis US, Inc1,080
Active, not recruiting
Phase 1
To evaluate the efficacy and safety of CNP520 in participants at risk for the onset of clinical symptoms of Alzheimer's Disease (AD)Alzheimer's diseaseMedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2016-002976-28-ITOVARTIS PHARMA AG1,144
Active, not recruiting
Phase 1
Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173Primary Sjögren's syndromeMedDRA version: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2014-004616-12-DEovartis Pharma Services AG30
Active, not recruiting
Phase 1
Efficacy and safety of finerenone in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney diseaseType II Diabetes Mellitus and Diabetic Kidney DiseaseMedDRA version: 21.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2015-000950-39-ITBAYER AG12,800
Active, not recruiting
Not Applicable
A randomized, double-blind, placebo-controlled, parallel group, fixed-dose, 8-weektreatment, multi-center trial evaluating the dose effect relationship for efficacy and the safety of 3 oral doses of surinabant: 2.5, 5 and 10mg/day as an aid to smoking cessation in cigarette smokers - SURSMOKEAid to smoking cessation in cigarette smokersMedDRA version: 8.1Level: LLTClassification code 10057852Term: Nicotine dependenceEUCTR2006-005334-21-DEsanofi-aventis recherche et developpement805