Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: 1.Ayurvedic supplement which aids in Gas & Bloating (Cumin, Fennel, Long Pepper)
2.Ayurvedic supplement for mild Constipation (Avipattikar Churna, Triphala Churna)
3.Ayurvedic supplem
Sponsors
Tatvartha Health Private Limited
Eligibility
Inclusion criteria
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
Exclusion criteria: 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. 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. 4. Participant with history of significant surgeries affecting gastrointestinal function within the past six months. 5. Active gastrointestinal ulcers or a recent history of peptic or duodenal ulcers. 6. Hepatic disorders or fatty liver disease. 7. 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. 9. 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. 10. 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. 11. 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. 12. 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. 13. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess change in Gas and Bloating symptoms as measured by the PI adapted GSRS ScoreTimepoint: From baseline to week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 3.Assess the Adverse Events profile reported with Mool Healths customized Gut Health Regimen in participants with symptoms of Gas and Bloating.Timepoint: From baseline to week 4. | — |
Countries
India
Contacts
Public ContactSyed Atif Hussain
Strider Lifesciences Pvt Ltd
Outcome results
None listed