Health Condition 1: K318- Other specified diseases of stomach and duodenum
Conditions
Interventions
Intervention1: 1. Ayurvedic supplement to restore Acid Balance (Sonth, Marich and Pippali).
2. Ayurvedic supplement for Mild Constipation (Avipattikar Churna, Triphala Churna).
3. Ayurvedic supplement
Sponsors
Tatvartha Health Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males/females of age of 18 years and 65 years 2. 2. Patients with self-reported or physician-confirmed symptoms of Acidity for a minimum 2 weeks and currently experiencing at least 2 or more of the following symptoms: a) Heartburn b) Burning sensation c) Regurgitation d) Nausea/ vomiting e) Burping f) Bloating g) Sour / bitter taste h) Difficulty swallowing i) Chest pain j) Coughing k) Hoarseness l) Diarrhoea m) Headache 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 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.Participant with history of significant surgeries affecting esophageal or gastric 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 within the past 4 months. 8.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess change in Acidity symptoms as measured by the PI adapted GSAS Score.Timepoint: From baseline to Week 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate change in Acidity symptoms as measured by the PI adapted GSAS Score. 2. To assess changes in quality of life by evaluating stress levels and sleep patterns, as recorded in PI adapted GSAS Score. 3. To assess the Adverse Events profile reported with Mool Health s customized Gut Health Regimen in participant with symptoms of AcidityTimepoint: From baseline to Week 4. | — |
Countries
India
Contacts
Public ContactSyed Atif Hussain
Strider Lifesciences Pvt Ltd
Outcome results
None listed