Health Condition 1: K58- Irritable bowel syndrome
Conditions
Interventions
None listed
Sponsors
Bombay Hemp Company
Eligibility
Inclusion criteria
Inclusion criteria: a) Patients between 18 and 65 years of age diagnosed with IBS using IBS diagnostic Scale. b) Ability to consent to the study and able to read and write in English or local language. c) Subjects who are non-regular users of cannabis in any form (three times per week or more) and are willing to abstain for 1 week prior and during the study. d) Normal liver function (defined as aspartate aminotransferase 10-40 U/L and alanine aminotransferase 7-56 U/L) e) Normal renal function (defined as serum creatinine level Glomerular Filtration Rate (eGFR) equal or higher than 60) f) Accepting not to use products with the same end benefit during the entire study duration. g) Subjects willing to stop alcohol, caffeine and nicotine consumption during the study duration. h) Cooperating, ready to sign consent form and ready to comply with protocol procedures.
Exclusion criteria
Exclusion criteria: a)Previous serious adverse event or hypersensitivity to cannabis or cannabinoids. b) Subjects receiving opioids and other concomitant anxiety medications. c) Presence of significant cardiac disease (history of unstable ischemic heart disease, heart failure, severe and uncontrolled hypertension) that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction. d) Current substance use disorder evaluated by history. e) Life-time history of dependence on cannabis or diagnosis of cannabis use disorder. f) Pregnant women tested positive in UPT and lactating women or women planning pregnancy during the trial period. willing to ensure that they or their partner use effective contraception during the study period. g)Current use of cannabis in any form more than 3 times per week or use of cannabinoid based medications within 7 days of study entry and refusal to abstain for the duration of the study. h) Positive history for cannabinoids at screening or positive urine screening for other potential abuse substances (e.g. alcohol, cocaine, amphetamines and methamphetamines,unprescribed opioids). i) For whom the Investigator considers that he/ she will not be compliant with study procedures. j) Any clinically significant systemic or cutaneous disease, which may interfere with study procedures. k) Participation in another clinical trial for the same indication within 90 days of screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Improvement in IBSSS Scale ( Irritable Bowel Syndrome Severity Scoring Scale ) 2.Quality of life Score : Improvement in IBS 36Timepoint: 1.Improvement in IBSSS Scale ( Irritable Bowel Syndrome Severity Scoring Scale ) 2.Quality of life Score : Improvement in IBS 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Safety profile o Liver function test o Kidney function test 2.Self-evaluation for tolerance - Evaluation questionnaire for in use tolerance to capture any intolerance due to the product. Timepoint: 1.Safety profile o Liver function test o Kidney function test 2.Self-evaluation for tolerance - Evaluation questionnaire for in use tolerance to capture any intolerance due to the product. | — |
Countries
India
Contacts
Public ContactRohini Jat
National Institute of Ayurveda, deemed to be University, Jaipur
Outcome results
None listed