A Clinical Study on Oral Digestive Enzyme Blend for Managing Protein Digestion in Patients with Irritable Bowel Syndrome and Muscle Soreness: An Open-Label, Safety and Efficacy Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 1. To evaluate effectiveness of the test treatment in terms of change in Albumin/Globulin Ratio from baseline, pre and post administration of test treatment.
Study Overview
Brief Summary
Study Design Open-label, interventional, prospective clinical study with 30 adult participants (aged 18–60 years), equally divided into two study arms.
Study Arms
Arm 1: Patients with Irritable Bowel Syndrome (IBS) and protein indigestion.
Arm 2: Patients with muscle shortening, stiffness, swelling, and inflammation (muscle soreness).
Study Visits
Screening (within 21 days) – consent, demographics, medical history, safety labs.
Day 01 (Baseline & Treatment) – baseline evaluations, high-protein meal, test treatment administration, post-dose assessments at 6–8 hrs.
Day 30 (+2 days) – final safety and efficacy evaluations, labs, diary review, and treatment accountability
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •The subject is an adult male or female aged between 18 to 60 (both inclusive) years old.
- •Clinically diagnosed with irritable bowel syndrome (IBS) or indigestion or must show symptoms of IBS like diarrhoea, constipation or abdominal pain.
- •Subjects exhibiting symptoms of muscle soreness, including muscle shortening, inflammation, swelling, stiffness, and related discomfort
- •The subject is having refrigerator at their home for storage of test treatment.
- •The subject is willing to provide written informed consent, comply with the study procedures, and be present for all the visits.
- •The subject is willing to abstain from using any other treatments for irritable bowel syndrome during the study period, unless for a medical urgency.
- •The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
- •If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.
- •Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
- •Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration.
- •Subject’s reported with high total serum protein levels evaluated by the lab reports.
- •Subjects who have note participated in any other similar clinical study in last 3 months.
- •Willing to use test treatment throughout the study period.
- •The subject is willing to abstain from using any other treatments for muscle soreness during the study period, unless for a medical urgency.
Exclusion Criteria
- •The subject has participated in other clinical studies or received any investigational agent in the previous 30 days.
- •Subject’s reported with high creatine kinase levels evaluated by the lab reports.
- •The subject has a history of diagnosis of either hypertension, diabetes, or liver disease.
- •The subject has any other significant medical condition that could interfere with the study or pose a risk to the participant.
- •The subject has used medications that could influence the study outcomes, such as antibiotics, immunosuppressive drugs, and enzyme supplements within the last 4 weeks.
- •The subject has a history of alcohol abuse.
- •The subject is either pregnant, lactating, or plans on conceiving during the course of the study.
- •The subject has other significant gastrointestinal diseases (e.g., Crohn’s disease, ulcer colitis, celiac disease).
- •The subject has any condition that, in the judgment investigator, would compromise the safety or study integrity of subject.
Outcomes
Primary Outcomes
1. To evaluate effectiveness of the test treatment in terms of change in Albumin/Globulin Ratio from baseline, pre and post administration of test treatment.
Time Frame: 1.Baseline pre administration of test treatment on Day 01 and post-administration of test treatment after 6-8 hours of administration on Day 01 and on Day 30 (+2 Days). | 2.Baseline pre administration of test treatment on Day 01 and post administration of test treatment after 6-8 hours of administration on Day 01 and on Day 30 (+2 Days). | 3. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days). | 4. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days). | 5. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days).
2. To evaluate effectiveness of the test treatment in terms of change in Prealbumin and Total Serum Protein from baseline, pre and post administration of test treatment.
Time Frame: 1.Baseline pre administration of test treatment on Day 01 and post-administration of test treatment after 6-8 hours of administration on Day 01 and on Day 30 (+2 Days). | 2.Baseline pre administration of test treatment on Day 01 and post administration of test treatment after 6-8 hours of administration on Day 01 and on Day 30 (+2 Days). | 3. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days). | 4. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days). | 5. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days).
3 To evaluate effectiveness of the test treatment in terms of change in Creatine Kinase from baseline, pre and post administration of test treatment.
Time Frame: 1.Baseline pre administration of test treatment on Day 01 and post-administration of test treatment after 6-8 hours of administration on Day 01 and on Day 30 (+2 Days). | 2.Baseline pre administration of test treatment on Day 01 and post administration of test treatment after 6-8 hours of administration on Day 01 and on Day 30 (+2 Days). | 3. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days). | 4. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days). | 5. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days).
4. To evaluate effectiveness of the test treatment in terms of change in Lactate Dehydrogenase (LDH) from baseline, pre and post administration of test treatment.
Time Frame: 1.Baseline pre administration of test treatment on Day 01 and post-administration of test treatment after 6-8 hours of administration on Day 01 and on Day 30 (+2 Days). | 2.Baseline pre administration of test treatment on Day 01 and post administration of test treatment after 6-8 hours of administration on Day 01 and on Day 30 (+2 Days). | 3. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days). | 4. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days). | 5. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days).
5. To evaluate the effectiveness of the test treatment in terms of change in Troponin, Myoglobin level from baseline, pre and post administration of test treatment.
Time Frame: 1.Baseline pre administration of test treatment on Day 01 and post-administration of test treatment after 6-8 hours of administration on Day 01 and on Day 30 (+2 Days). | 2.Baseline pre administration of test treatment on Day 01 and post administration of test treatment after 6-8 hours of administration on Day 01 and on Day 30 (+2 Days). | 3. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days). | 4. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days). | 5. Baseline before administration of test treatment on Day 01 and post-administration of test treatment on Day 30 (+2 Days).
Secondary Outcomes
- 1. To evaluate effectiveness of test treatment in terms of change in Lifestyle using Scoring and Gradation of Lifestyle from baseline, pre and post administration of test treatment.(pre-administration of test treatment on Day 01 and post administration of test treatment on Day 30)
- 2. To evaluate effectiveness of test treatment in terms of change in Scoring and Gradation of Symptoms of Irritable Bowel syndrome from baseline, pre and post administration of test treatment.(pre-administration of test treatment on Day 01 and post administration of test treatment post 6-8 hours of administration on Day 01 and Day 30)
- 3. To evaluate effectiveness of test treatment in terms of change in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS) from baseline, pre and post administration of test treatment(pre-administration of test treatment on Day 01 and post administration of test treatment post 6-8 hours of administration on Day 01 and Day 30)
- 1. To evaluate the effectiveness of test treatment in terms of change in VAS scoring scale for muscle soreness from baseline, pre and post administration of test treatment.(pre-administration of test treatment on Day 01 and post administration of test treatment on Day 30)
- 2. To evaluate the effectiveness of test treatment in term of Treatment Perception Questionnaire from baseline, pre and post administration of test treatment.(pre-administration of test treatment on Day 01 and post administration of test treatment on Day 30)
Investigators
Dr Vipul Prajapati MBBS MD
NovoBliss Research Private Limited