Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Boswellia Serrata Extract Capsules 200mg: Boswellia Serrata
Dose:200mg
Frequency:Once Daily
Route of Administration:Oral
Duration of Therapy:84 Days
Control Intervention1: Placebo: NIL
Sponsors
Inventia Healthcare Limited
Eligibility
Inclusion 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 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
Exclusion criteria
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of Boswellia serrata extract 200 mg capsules in subjects with IBSTimepoint: The primary Outcome will be assessed data obtained on 84th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the change in gut microbiota due to Boswellia serrata extract 200 mg capsules. To monitor the safety and tolerability of Boswellia serrata extract 200 mg capsules Timepoint: The Secondary Outcome will be assessed data obtained on 84th day. | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed