Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Intervention1: 1. Ayurvedic supplement for mild Constipation (Avipattikar Churna, Triphala Churna)
2. Ayurvedic supplement for severe Constipation (natural laxative)
3. Ayurvedic supplement for improv
Sponsors
Tatvartha Health Private Limited,
Eligibility
Inclusion criteria
Inclusion criteria: 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.
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.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change in IBS symptoms, score as measured by the PI Adapted IBS-SSS Score and Bristol Stool ChartTimepoint: From baseline to Day 84. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: From baseline to week 3, 6, 9, and 12 time points. | — |
Countries
India
Contacts
Public ContactSyed Atif Hussain
Strider Lifesciences Pvt Ltd
Outcome results
None listed