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CTRI Number  CTRI/2024/11/076790 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 06/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study of nutraceutical supplement in the management of gut health.  
Scientific Title of Study   A randomized, double-blind, placebo-controlled clinical trial of nutraceutical formulation in improving gut health in adults. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/037 Version 1.00, dated 14th October 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramshyam Agarwal 
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  Fourth floor OPD 401 314 B Telco Road Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  8087282022  
Fax  -  
Email  ramshyam.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaishnavi Patil 
Designation  Project Coordinator 
Affiliation  Life Synergy 
Address  Office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner

Pune
MAHARASHTRA
411045
India 
Phone  9834585994  
Fax  -  
Email  vaishnavilifesynergy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaishnavi Patil 
Designation  Project Coordinator 
Affiliation  Life Synergy 
Address  Office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner


MAHARASHTRA
411045
India 
Phone  9834585994  
Fax  -  
Email  vaishnavilifesynergy@gmail.com  
 
Source of Monetary or Material Support  
Life Synergy office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner, Pune 411045, Maharashtra 
 
Primary Sponsor  
Name  Life Synergy 
Address  Office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner, Pune 411045, Maharashtra. 
Type of Sponsor  Other [Nutraceutical product promoter] 
 
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 Ramshyam Agarwal  Lokmanya Medical Research Centre and Hospital  Fourth Floor OPD room no 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 		 8087282022
-
ramshyam.research@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K929||Disease of digestive system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LS/24-25/Gut001  1 tablet twice a day for 60 days 
Intervention  LS/24-25/Gut002   1 tablet twice a day for 60 days 
Comparator Agent  Placebo  1 tablet twice a day for 60 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Males and females aged 20-50years, with an equal gender distribution (both inclusive); 2.Participants must report one or more gut health-related symptoms, indicated by a GSRS score of 3 to 5 or a BSFS score of 1 to 3. Eligible symptoms include:•Bloating•Abdominal discomfort or pain•Infrequent bowel movements fewer than three defecations per week•Hard or lumpy stools types 1 to 3 on the Bristol Stool Form Scale•Sensation of incomplete evacuation during defecation.3.Participants in whom loose stools are rarely present without the use of laxatives;4.Participants on stable medication for the past three months with no worsening of symptoms or hospitalization are eligible, or may be enrolled at the discretion of the investigator;5.Participants should agree to undergo Liver Function Tests and C-reactive protein assessments;6.Willingness to undergo baseline and follow-up assessments of gut health using the GSRS;7.Participants providing voluntary, written informed consent to participate in the study. 
 
ExclusionCriteria 
Details  1.Participants with a diagnosis of colonic inertia;
2.Participants with a history of surgical interventions within the last six months;
3.History of anorectal surgery;
4.Participants diagnosed with functional gastrointestinal disorders, including Functional Constipation, Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), or chronic diarrhea;
5.Participants with structural abnormalities such as rectal prolapse, rectocele, or anorectal stricture;
6.Participants with untreated or uncontrolled systemic conditions, including HIV, diabetes mellitus, or tuberculosis;
7.Participants with renal or liver dysfunction;
8.Participants with neurological disorders, such as Parkinsons disease or multiple sclerosis;
9.A medical history of hypothyroidism, Grade 2 obesity, morbid obesity, or constipation associated with premenopausal or postmenopausal status;
10.Participants currently using laxatives, antacids, proton pump inhibitors, antibiotics, or other probiotic products;
11.Participants using herbal supplements, dietary fiber, or phytonutrient supplements;
12.Participants will be excluded if they have initiated new micronutrient supplements e.g. iron, zinc within the past 14 days;
13.Participants who have undergone colonic cleansing in the last three months;
14.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study;
15.Participants with a history of substance abuse or heavy use of alcohol and drugs or tobacco use, where participants smoke more than 1 or 2 pack per day;
16.Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Assessing Gut health using a Gastrointestinal Symptom Rating Scale GSRS score.
2. Patient Assessment of Upper Gastrointestinal Symptom Severity Index PAGI SYM Assessment of symptoms such as heartburn, nausea, and bloating.
3. Changes in body weight.
4. Gastrointestinal Quality of Life Index GIQLI Measurement of the impact of digestive symptoms on overall quality of life, including energy, fatigue, and well being will be measured
5. Stool Consistency and Frequency: Bristol Stool Form Scale BSFS Evaluating stool consistency. Frequency of Bowel Movements Self reported daily bowel movements recorded using a bowel diary. 		 1. At screening, day 30 and day 60.
2. From baseline to end of the study.
3. From baseline to end of the study.
4. At baseline and end of the study.
5. From baseline to end of the study.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of adverse events
2. Assessment of treatment compliance and tolerability of investigational products.
3. Assessment of changes in vital sign parameters.
4. Assessment of changes in complete blood count, liver function test and kidney function test. 		 1. From baseline to end of the study.
2. Throughout the study.
3. Throughout the study.
4. At screening and end of the study. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   18/11/2024 
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="4"
Days="0" 
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   Gut health plays a critical role in overall well-being, influencing digestion, immunity, metabolism, and even mental health. However, imbalances in gut microbiota, inflammation, and digestive disorders are common, and current treatments may be insufficient or have unwanted side effects. Nutraceuticals, which consist of bioactive compounds from food sources, have shown potential to improve gut health by promoting a balanced gut microbiome, enhancing nutrient absorption, and reducing gastrointestinal discomfort. Preclinical and limited clinical studies have suggested that specific formulations of nutraceuticals may offer protective and therapeutic benefits to gut health.
By using a placebo control and a double-blind design, this trial aims to provide robust data on the true efficacy of these formulations. If successful, these nutraceuticals could offer a natural, side-effect-free alternative for individuals seeking to improve gut health, with broader implications for managing gut-related conditions and improving general wellness.
 
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