1. Ayurvedic supplement for mild Constipation (Avipattikar Churna, Triphala Churna)
2. Ayurvedic supplement for severe Constipation (natural laxative)
3. Ayurvedic supplement for improved Bowel Movement (Guduchi, Sonth, Piper Longum)
4. Ayurvedic supplement for better Mood & Sleep (Brahmi, Ashwagandha, Tagar)
5. Ayurvedic supplement which aids in Gas & Bloating (Cumin, Fennel, Long Pepper)
6. Ayurvedic supplement that restores Acid Balance (Sonth, Marich and Pippali)
7. Probiotic (S. boulardi)
8. Probiotic (Bacillus coagulans)
1. Ayurvedic supplement for mild Constipation: alleviates mild constipation.
2. Ayurvedic supplement for severe Constipation: detoxifies, cleanses the GI tract.
3. Ayurvedic supplement for improved Bowel Movement: enhances digestion, reduces bloating, and balances doshas for gut health.
4. Ayurvedic supplement for better Mood & Sleep: Reduces stress, promotes sleep, and supports gut-brain balance for digestive health.
5. Ayurvedic supplement which aids in Gas & Bloating: supports digestion, relieves gas and bloating, and detoxifies the gut.
6. Ayurvedic supplement that restores Acid Balance: neutralizes excess stomach acid and soothes the digestive tract.
7. Probiotic for gentle yet powerful relief for Diarrhea and Digestive Recovery: support digestive system by addressing diarrhea
8. Probiotic which targets Gas, Bloating, and IBS at the root: targets root causes of gut issues like gas, bloating, and IBS.
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1.Males/females of age of 18 years and 65 years.
2.Persistent symptoms of abdominal pain, bloating, and altered bowel habits for at least 3 months prior to screening.
3.Participants who can and are willing to provide written Informed Consent.
4.Participants who are willing to follow dietary instructions.
5.Female participant of child-bearing potential must agree to practice a medically acceptable method of birth control during the study period.
6.Participants must agree not to undergo any other type of treatment or procedure for his/her current problem during the study.
ExclusionCriteria
Details
1.Participant with a known history of allergy to any of the ingredients of the nutraceutical regimen or history or presence of multiple severe allergies.
2.Female participant who is pregnant or planning pregnancy during the study period or breastfeeding.
3.Participant with history of significant surgeries affecting gastrointestinal function within the past 6 months
4.Participant with active gastrointestinal ulcers or a recent history of peptic or duodenal ulcers.
5.Participant with hepatic disorders or fatty liver disease.
6.Participant with skin disorders related to immune function, such as seborrheic dermatitis
7.Participant with history of previous treatment with test product/s within the past 4 months.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
To assess the change in IBS symptoms, score as measured by the PI Adapted IBS-SSS Score and Bristol Stool Chart
From baseline to Day 84.
Secondary Outcome
Outcome
TimePoints
1. Evaluate change in IBS symptoms as measured by the PI adapted IBS-SSS Score and Bristol Stool Chart.
2. Assess changes in quality of life by evaluating stress levels and sleep patterns as recorded in PI adapted IBS-SSS Score.
3. Assess the Adverse Events profile reported with Mool Healths customized Gut Health Regimen in participants with IBS.
From baseline to week 3, 6, 9, and 12 time points.
Target Sample Size
Total Sample Size="38" Sample Size from India="38" Final Enrollment numbers achieved (Total)= "38" Final Enrollment numbers achieved (India)="38"
Phase of Trial
Post Marketing Surveillance
Date of First Enrollment (India)
07/04/2025
Date of Study Completion (India)
17/07/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="5" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
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
This is a prospective, double-blind, clinical study designed to evaluate the clinical effectiveness and safety of Mool Health’s customized Gut Health Regimen over an 84-day intervention period in participants with irritable bowel syndrome (IBS). The primary objective is to assess changes in IBS symptom severity from baseline using tools such as the PI adapted IBS Symptom Severity Scale (IBS-SSS) and the Bristol Stool Chart.
Eligible participants aged 18 to 65 years, with a confirmed diagnosis of IBS, will be screened for inclusion and exclusion criteria. After providing informed consent, participants will undergo a detailed symptom evaluation conducted by the Principal Investigator (PI) using the PI Symptom Evaluation Form, the Online Symptom Evaluation Form, the PI adapted IBS-SSS, and the Bristol Stool Chart to establish baseline symptom severity.
Participants meeting the eligibility criteria will be scheduled for a kit dispensing visit, which may occur on the same day as screening or within 48 hours. During this visit, each participant will receive Mool Health’s customized Gut Health Regimen based on the PI’s clinical evaluation, the participant’s online symptom profile, and an algorithm-based software tool designed by study sponsor to ensure consistent and accurate kit customization. The regimen will include one or more combinations of Ayurvedic, and nutraceutical products designed to alleviate IBS symptoms. Participants will also receive a diary to record medication compliance and symptom progression.
The study intervention will last 12 weeks, during which participants will be monitored for safety, compliance, and symptom progression. Study assessments will be conducted at five key time points: a baseline screening visit (prior to regimen initiation) and follow-up visits on Days 21, 42, 63, and 84. At each follow-up visit, PI/ designee will complete the PI adapted IBS-SSS and the Bristol Stool Chart to evaluate changes in symptom severity.
The double-blind design ensures that neither participants nor Investigators are aware of the specific regimen composition, minimizing bias in outcome assessments. The final visit on Day 84 will serve as the end-of-study assessment to evaluate the overall effectiveness of the intervention and document any adverse events. This study design ensures robust data collection to support the evaluation of the Gut Health Regimen’s clinical utility in managing IBS symptoms.