A clinical trial to study effectiveness and safety of Mool Healths customized Gut Health Regimen in participants with symptoms of Gas and Bloating.

Not Applicable

Recruiting

Conditions: Other specified diseases of the digestive system,

Registration Number: CTRI/2025/03/082201

Lead Sponsor: Tatvartha Health Private Limited

Brief Summary: This is a prospective, double-blind, clinical study designed to evaluatethe clinical effectiveness and safety of Mool Health’s customized Gut HealthRegimen in participants experiencing symptoms of Gas and Bloating. The studywill be conducted over a 28-day intervention period.

Eligibleparticipants, aged 18 to 65 years, experiencing self-reported or PI diagnosedsymptoms of Gas and Bloating, will be screened for inclusion and exclusioncriteria. Following the signing of informed consent, participants will undergoa symptom evaluation conducted by the Principal Investigator (PI) using the PISymptom Evaluation Form,the Online SymptomEvaluation Form andthe PI adapted GastrointestinalSymptom Rating Scale GSRS. Participants meeting theeligibility criteria will be assigned Mool Health’s customized Gut HealthRegimen based on the PI’s clinical evaluation, the participant’s online symptomprofile, and an algorithm-based software designed by study sponsor to ensureconsistent and accurate customization. The regimen will include one or morecombination of ayurvedic and nutraceutical products aimed at alleviating Gasand Bloating symptoms.

Participants will follow the regimen for 28 days,with study assessments scheduled at five key time points. These include ascreening visit, during which symptom evaluations and baseline assessments areperformed; a kit dispensing visit for regimen assignment and participanteducation, which may occur on the same day or within 48 hours of screening; andweekly follow-up visits on Days 7, 14, and 21 to monitor symptom progression,compliance and adverse events. The final visit on Day 28 will serve as the end-of- studyassessment to evaluate the overall effectiveness of the intervention andmonitor adverse events. Throughout the study, a double-blind design ensuresthat neither the participants nor the Investigators are aware of the specificregimen composition, minimizing bias in outcome assessment.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 38

Inclusion Criteria

1.Males/females of age of 18 years and 65 years.
2.Patients with self-reported or physician-confirmed symptoms of Gas and Bloating for minimum 2 weeks and currently experiencing at least 2 or more of the following symptoms: a Abdominal pain b Heartburn c Burning Sensation d Acid regurgitation e Sucking sensations in the epigastrium f Persistent or recurrent nausea or vomiting g Borborygmus h Abdominal distension i Eructation (Burping) j Increased flatus k Constipation l Diarrhoea m Change in frequency of bowel movements n Weight loss 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 or her current condition during the study.

Exclusion Criteria

Participant with a known history of allergy to any of the ingredients of the nutraceutical regimen or history or presence of multiple severe allergies.
Female participant who is pregnant or planning pregnancy during the study period or breastfeeding.
Participants with diagnosed severe gastrointestinal disorders like IBS history of inflammatory bowel disease haemorrhoids active peptic ulcer disease or gastric outlet obstruction celiac disease colorectal cancer malignancies or others.
Participant with history of significant surgeries affecting gastrointestinal function within the past six months.
Active gastrointestinal ulcers or a recent history of peptic or duodenal ulcers.
Hepatic disorders or fatty liver disease.
Participant with skin disorders related to immune function such as seborrheic dermatitis 8.
Participant with history of previous treatment with test product within the past four months.
Participant having a mental or physical condition that would in the opinion of the Investigator place the participant at an unacceptable risk or render the participant unable to meet the requirements of the protocol or interfere with the ability to provide consent or complete study requirements.
Participant with a history of participation in another clinical study involving an investigational product within the past three months prior to the start of this study or planning participation in another clinical trial during the current study duration.
Participant with a history of Acute or Chronic illness that may compromise immune function or overall health and other severe debilitation conditions like uncontrolled diabetes renal insufficiency hepatic impairment or any life-threatening conditions.
History or concurrent use of antacids probiotic prebiotics digestive enzymes medications or supplements for constipation that significantly alter gastrointestinal motility or other nutraceuticals targeting Gas and Bloating or interfere with gastrointestinal function within two weeks prior to enrollment into the study.
Participant having or has received antibiotics anti-inflammatory drugs or any other substance known to increase the gastrointestinal symptoms from ten days prior to study enrolment and during the study duration.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess change in Gas and Bloating symptoms as measured by the PI adapted GSRS Score	From baseline to week 4

Secondary Outcome Measures

Name	Time	Method
1.Evaluate change in Gas and Bloating symptoms as measured by the PI adapted GSRS Score.	2.Assess changes in quality of life by evaluating stress levels and sleep patterns, as recorded in PI adapted GSRS Score.

Trial Locations

Locations (1): Punawale Multispecialty Hospital
🇮🇳
Pune, MAHARASHTRA, India
Punawale Multispecialty Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr Mandar Vijay Doiphode
Principal investigator
9850077168
dr.mandardoiphode9@gmail.com