CTRI/2021/10/037072Active, not recruitingPhase 2
A prospective, randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of dietary supplement Pepzyme Pro on the digestion and absorption of Pea protein.
Advanced Enzymes Ltd0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Adult Indian male or female with age 18 to 35 years [both inclusive] at the time of signing informed consent.
- •2. Normal body weight (body mass index (BMI) of 19ââ?¬â??24.99 kg/m2)
- •3. Willingness to provide written informed consent and comply with study instructions for its duration and agree not to participate in other clinical studies within 30 days after the last administration from the first administration of the study drug.
- •4. Must be of normal health as determined by medical history and physical examination within 28 days prior to the commencement of the study.
- •5. Screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
Exclusion Criteria
- •The subjects will be excluded based on the following criteria during screening and during the study.
- •1. Any individual who was treated or diagnosed with a gastrointestinal, cardiac, respiratory, circulatory, musculoskeletal, metabolic, immune, autoimmune, psychiatric, hematological, neurological, or endocrinological disorder
- •2. Participants who were determined to not be weight stable defined as measured body mass deviating by 5%
- •3. Participants who were not willing to abstain from alcohol, nicotine, and caffeine for 12 h prior to each visit
- •4. Subject s who have received organ transplantation or surgery in the past 6 months
- •5. Known hypersensitivity or idiosyncratic reaction or intolerance to Pepzyme Pro /Protein diet or any ingredients of the formulation or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs or food products.
- •6. Women subjects that are pregnant or lactating, or subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation) during the study period
- •7. Allergic to enzyme supplements
- •8. Subject s who have participated in any other clinical study within 2 weeks prior to randomization
- •9. The investigators conclude that the Subject is not suitable for the study.
- •10. History of smoking or Tobacco consumption
- •11. Intake or administered protein supplements, enzyme supplements or any drugs or over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study drug administration in the study.
- •12. History of clinically significant, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •13. Difficulty with donating blood.
- •14. Following any particular protein-rich dietary regime, muscle toning or body building program or not willing to discontinue such regime or program during the conduct of study.
Investigators
Similar Trials
Not yet recruiting
Phase 2
To evaluate the effectiveness of DigeSEB Super PB on digestion and gastrointestinal symptoms in healthy adultsCTRI/2023/10/058902Advanced Enzyme Technologies Ltd
Recruiting
Phase 4
A prospective, randomized, double-blind, placebo-controlled and multicenter trial for Tanreqing capsule in the treatment of patients with AECOPD with upper respiratory tract infectioChronic obstructive pulmonary diseaseITMCTR2100005207Shanghai Minhang District Central Hospital
Not yet recruiting
Not Applicable
Beta-alanine supplementation in patients with COPD receiving non-linear periodized exercise (NLPE) training: randomized placebo-controlled trial.Chronic obstructive pulmonary disease (COPD)Exercise intoleranceMuscle dysfunction.NL-OMON23943Radboudumc Board of Directors154
Active, not recruiting
Phase 1
A prospective, randomized, double-blind, placebo-controlled, international, multicentre, parallel-group comparison trial evaluating the efficacy and safety of single i.v. bolus tenecteplase plus standard anticoagulation as compared with standard anticoagulation in normotensive patients with acute pulmonary embolism and with echocardiographic (or spiral CT) and laboratory evidence of right ventricular dysfunction. - PEITHOPatients suffered from acut pulmonary embolism.EUCTR2006-005328-18-HUAssistance Publique - Hôpitaux de Paris (AP-HP)1,000
Active, not recruiting
Not Applicable
A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis.MedDRA version: 7Level: PTClassification code 10028417Myasthenia gravisEUCTR2004-000596-34-HUF. Hoffmann-La Roche Ltd as part of the Aspreva Rare Disease Program136