actase Enzyme chewable tablets in Lactose Malabsorption and Intolerance
Phase 4
Completed
- Conditions
- Health Condition 1: null- Lactose intolerance
- Registration Number
- CTRI/2018/03/012295
- Lead Sponsor
- Walter Bushnell Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
The patient should be a male or female, aged between 18 and 65 years old
Have a medical history consistent with lactose intolerance, confirmed by the test of hydrogen in the expired air
To be able to meet the study instructions and all the visits required.
To give a free consent to participate in the study and sign the informed consent form (ICF).
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method I.Exhaled hydrogen concentration 90 minutes after the ingestion of 25 g of lactose (with or without lactase) measured on day of test.Timepoint: 8HRS
- Secondary Outcome Measures
Name Time Method Exhaled hydrogen concentration over 180 minutes on test Day <br/ ><br>II.Scores for specific symptoms (Abdominal pain, Bloating, Nausea, Flatulence, Borboygmi, Diarrhoea) recorded during the hydrogen breath test and evaluated through a visual analogue scale (VAS, 0 [absent] to 10 [most intense possible]). <br/ ><br>Safety endpointsTimepoint: 8HRS