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CTRI Number  CTRI/2020/02/023555 [Registered on: 25/02/2020] Trial Registered Prospectively
Last Modified On: 29/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to know the efficacy and safety of Gut health product in the management of gut health and intestinal microflora in healthy subject. 
Scientific Title of Study   A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Gut health product in the management of gut health and intestinal microflora in healthy subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BIAG-CSP-005 version 1.0, 10 Dec 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajanna M 
Designation  Consultant –Physician 
Affiliation  Arogyavardhini Ayurvedic Centre 
Address  No:2, 5th Cross, Giddappa Layout,Kammanahalli, St Thomas Town Post, Bangalore

Bangalore
KARNATAKA
560084
India 
Phone  9880367601  
Fax    
Email  mdrrajanna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shalini Dayananda 
Designation  A.V.P. 
Affiliation  Bio Agile Therapeutics Private Limited 
Address  #2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka

Bangalore
KARNATAKA
560094
India 
Phone  08043754520  
Fax    
Email  pm@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query  
Name  Divya C 
Designation  Director 
Affiliation  Bio Agile Therapeutics Pvt. Ltd 
Address  #2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka

Bangalore
KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
Sponsored study PlantlipidsPlant lipids (P) LTD Kolenchery, Cochin - 682 311  
 
Primary Sponsor  
Name  Plantlipids P Ltd 
Address  Kolenchery, Cochin  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajanna M  Arogyavardhini Ayurvedic Centre  No:2, 5th Cross, Giddappa Layout,Kammanahalli, St Thomas Town Post, Bangalore-560084
Bangalore
KARNATAKA 		 9880367601

mdrrajanna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Gut health 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  250mg x 2capsules (total 500mg) once daily for a period of 8 weeks. 
Intervention  Study drug  250mg x 2capsules (total 500mg) once daily for a period of 8 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Male or Female, age between 18years to 50years
2. BMI between 18 and 29 kg/m2
3. Female participant is not of childbearing potential or Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
4. Good general health, as determined by medical history, laboratory analysis, and physical examination performed by the study physician
5. Willing to maintain current exercise and dietary regimen as well willing to collect faecal samples during the study.
6. May need to exclude or limit turmeric and asafoetida as spices or supplements from the diet for the duration of the study to minimize confounding factors.
7. Has normal results from their blood work (CBC with differential, lipid panel, and fasting glucose) and, stool (occult blood and pH) and urine analysis prior to enrolment.
8. Has given voluntary, written, and dated informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Women who are pregnant, breastfeeding or planning to become pregnant
2. Daily use of supplements that contain probiotics, prebiotics, or synbiotics within the 30 days prior to screening or during the study
3. Daily consumption of foods containing significant amounts of sugar alcohols such as xylitol, mannitol, maltitol, sorbitol, and mannitol (>20g/d). Examples include sugar-free or reduced-sugar protein bars.
4. Acute infection requiring systemic antibiotic or antiviral therapy or use of antibiotics (within the 30 days prior to screening).
5. Regular use of anti-inflammatory medication, including 81 mg aspirin, (more than once per week), or if prescribed by a physician.
6. Diarrheal illness (within the 30 days prior to screening)
7. Current anemia or Iron supplements
8. Rectal bleeding or “frank blood” or occult in the feces or clinically significant abnormal results from routine fecal analysis
9. Allergy or sensitivity to study supplement ingredients
10. Use of illicit drugs or drug abuse within the last year
11. Currently consume greater than 2 standard alcoholic drinks per day or has a history of alcohol abuse within the past 5 years
12. Currently active smokers (tobacco products, and e-cigarettes) or smoking within the 6 months of enrollment
13. Previously or currently diagnosed with an eating disorder
14. Current, or previous history of gastrointestinal disorders (e.g. IBS, gastric ulcers, Crohn’s disease or Colitis)
15. Type 1 and Type 2 Diabetes Mellitus and individuals on diabetic medications
16. Current, or history of within last 5 years, renal disease
17. Current, or history of within last 5 years, hepatic disease
18. Immunocompromised individuals such as those that have undergone organ transplantation, those with rheumatoid arthritis, or subjects diagnosed with human immunodeficiency virus (HIV), AIDS, or hepatitis
19. Medical history of or current thyroid disease
20. Cancer, except skin cancers, completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
21. Currently diagnosed with, or history of, cardiovascular disease
22. Current, or history of, bleeding disorders
23. Uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic >90 mmHg)
24. Current, or historical diagnosis of, or individuals on medication for, a sleep disorder, clinical depression, or anxiety by verbal communication and as assessed by the qualified investigator
25. Anti-psychotic medication, or with a history of psychiatric disorder by verbal communication and as assessed by the qualified investigator
26. Participation in a clinical research trial within 30 days of enrolment
27. Clinically significant abnormal laboratory results at screening
28. Any medical condition or use of any medication, nutritional product, dietary supplement, or program which, in the opinion of the investigator, might interfere with the results or conduct of the study or place the subject at risk.
29. Any other condition which in the qualified investigator’s opinion may adversely affect the individual’s ability to complete the study or its measures or which may pose significant risk to the individual.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Change in haematological parameters as compared on Day 0 and Day 60.
2.Change in lipid profile as compared on Day 0 and Day 60.
3.Change in feacal microbiota CFUs as compared on Day 0 and Day 60.
4.Change in immunological marker as compared on Day 0 and Day 60.
 		 1.Change in haematological parameters as compared on Day 0 and Day 60.
2.Change in lipid profile as compared on Day 0 and Day 60.
3.Change in feacal microbiota CFUs as compared on Day 0 and Day 60.
4.Change in immunological marker as compared on Day 0 and Day 60.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in Quality of life questionnaires as assessed by Gastrointestinal Symptoms Rating Scale (GSRS) at different study time points (Day 1 and Day 60)
2.Change in Stool frequency as assessed by average of the bowel habits diary by by Bristol Stool Form Scale (BSS) ( Day 1 and 60)
 		 Screening Visit:Day -3 to Day 0,Baseline visit:Day 1,Week 4(Day 30),End of the visit Week 8 (Day 60) 
 
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)   25/02/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Recent discoveries in the structure and function of the microbiome suggested that diet may have a direct impact on the intestinal microbiota and human or animal health 

status, and disruptions of microbe–man relationships may result in different disease states, including chronic inflammation, autoimmunity and neurological disorders. 

A higher effectiveness of probiotics over other agents for BMI, body weight and fat loss could be explained by the hypothesis that alteration of the gut microbiome is more predictable and successful with probiotics.Thus, Probiotics have been proposed as preventive and therapeutic measures, in order to restore the healthy composition and function of the gut microbiome.In order to reduce/avoid the major side effects produced from the conventional pharmacological treatment options, the present exploratory clinical study has been designed.
 

 

 
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