| CTRI Number |
CTRI/2025/11/096983 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of an Oral Digestive Enzyme Supplement on Protein Digestion in People with Irritable Bowel Syndrome and Muscle Soreness |
|
Scientific Title of Study
|
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 Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250010-MB_1.0_23Sep25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vipul Prajapati MBBS MD |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
consultant@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Sub investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
Dr Nayan Patel
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Private Limited, Ahmedabad
Ahmadabad
GUJARAT
382421
India |
| Phone |
09909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Meteoric Biopharmaceuticals Pvt. Ltd.
9th Floor, Earth Arise,
Near YMCA Club, S.G Highway, Makarba,
Ahmedabad – 380 015, Gujarat, India.
|
|
|
Primary Sponsor
|
| Name |
Meteoric Biopharmaceuticals Pvt. Ltd. |
| Address |
9th Floor, Earth Arise,
Near YMCA Club, S.G Highway, Makarba,
Ahmedabad – 380 015, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
NovoBliss Research Private Limited |
Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT |
09909013286
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M624||Contracture of muscle, (2) ICD-10 Condition: K588||Other irritable bowel syndrome, (3) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MetDigestenz – Digestive Enzyme Blend |
Mode of Administration Take one tablet twice a day, after meal
Frequency Twice a day after the meal
Route of Administration Oral
Dosage Form Tablet
|
| Comparator Agent |
None |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The subject is an adult male or female aged between 18 to 60 (both inclusive) years old.
2. Clinically diagnosed with irritable bowel syndrome (IBS) or indigestion or must show symptoms of IBS like diarrhoea, constipation or abdominal pain.
2. Subjects exhibiting symptoms of muscle soreness, including muscle shortening, inflammation, swelling, stiffness, and related discomfort
3. The subject is having refrigerator at their home for storage of test treatment.
4. The subject is willing to provide written informed consent, comply with the study procedures, and be present for all the visits.
5. The subject is willing to abstain from using any other treatments for irritable bowel syndrome during the study period, unless for a medical urgency.
6. The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
7. If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.
i. 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).
ii. 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.
8. Subject’s reported with high total serum protein levels evaluated by the lab reports.
9. Subjects who have note participated in any other similar clinical study in last 3 months.
10. Willing to use test treatment throughout the study period.
11. The subject is willing to abstain from using any other treatments for muscle soreness during the study period, unless for a medical urgency. |
|
| ExclusionCriteria |
| Details |
1. The subject has participated in other clinical studies or received any investigational agent in the previous 30 days.
2. Subject’s reported with high creatine kinase levels evaluated by the lab reports.
3. The subject has a history of diagnosis of either hypertension, diabetes, or liver disease.
4. The subject has any other significant medical condition that could interfere with the study or pose a risk to the participant.
5. The subject has used medications that could influence the study outcomes, such as antibiotics, immunosuppressive drugs, and enzyme supplements within the last 4 weeks.
6. The subject works in frequent night shifts (working night shifts at least 3 times per week), and refuses to change the lifestyle.
7. The subject has a history of alcohol abuse.
8. The subject is either pregnant, lactating, or plans on conceiving during the course of the study.
9. The subject has participated in other clinical studies or received any investigational agent in the previous 30 days.
10. The subject has other significant gastrointestinal diseases (e.g., Crohn’s disease, ulcer colitis, celiac disease).
11. The subject has any condition that, in the judgment investigator, would compromise the safety or study integrity of subject. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
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.
3 To evaluate effectiveness of the test treatment in terms of change in Creatine Kinase from baseline, pre and post administration of test treatment.
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.
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.
|
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 Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |