Boswellia serrata extract 200 mg capsules in subject with Irritable Bowel Syndrome.
- Conditions
- Health Condition 1: K928- Other specified diseases of the digestive system
- Registration Number
- CTRI/2019/11/022190
- Lead Sponsor
- Inventia Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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
Acceptable methods of contraception are
Oral or other For Example injection patch or implant hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication
Intrauterine device IUD or intrauterine system IUD or IUS
Double barrier method of contraception condom and occlusive cap or condom and spermicidal agent
Male sterilization at least 6 months prior to the screening should be the sole male partner for that subject
Female sterilization surgical bilateral oophorectomy or tubal ligation at least 6 weeks prior to study participation
Total abstinence partial abstinence is not acceptable
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.
10.Subjects having the following laboratory results at screening:
a.Hemoglobin (Hb) less than 9 g/dL
b.AST and ALT > 3.0 x ULN
c.Alkaline phosphatase > 3.0 x ULN
d.Serum Creatinine level > 1.25 x ULN
11.Subjects on anticoagulant and/or antiplatelet medications such as aspirin, clopidogrel or warfarin.
12.Subjects with surgical or other non-healing wounds.
13.Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
14.Participation in any clinical study within 30 days prior to receiving the first dose of Investigational Product.
15.Any other medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the subject to participate in the study including but not limited to psychiatric illness/social situations that would limit adherence to study requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method