None listed
Conditions
Interventions
Intervention1: De-stress & happy gut powder-U001: Take one sachet daily, 30 minutes before breakfast, for 60 days.
Intervention2: De-Stress & Happy Gut powder-I001: Take one sachet daily, 30 minutes b
Sponsors
Herbolab India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female participants aged 21-50 years both inclusive 2.Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26 3.Participants willing to participate in clinical trials and who have read understood and signed the informed consent form 4.No severe anxiety and depression i.e, Generalized anxiety disorder GAD score less than or equal to 10 and Patients’ health questionnaire-9 PHQ-9 score less than or equal to 14 5.Diagnosis of functional dyspepsia/non-ulcer dyspepsia by fulfilling Rome-III criteria 6.Participant should be suffering with at least 4 or more symptoms mentioned below and with a total symptom score of 20 or more based on a 7-point Likert scale (a) Upper abdominal fullness (b) Upper abdominal pain (c) Belching (d) Bloating (e) Early satiety (f) Nausea (g) Vomiting (h) Regurgitation (i) Heartburn (j) Loss of appetite
Exclusion criteria
Exclusion criteria: 1.Inability to perform any of the assessments required for endpoint analysis 2.Known hypersensitivity to investigational products 3.Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within last 5 years 4.Advanced chronic illness that would impair follow-up or monitoring 5.Participants who have used dietary supplements, medications, such as oral/IV antibiotics or probiotics, or supplements known to affect hunger, satiety, appetite, or gut microbiome within three months prior to recruitment. Additionally, individuals currently using nutraceuticals, allopathic, or ayurvedic supplements for stress and or gastrointestinal health management; 6.Participants suffering from abdominal obesity that is waist circumference of more than 80 cm in females and of more than 90 cm in male; 7.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study 8.Participants with current or past diagnoses of peptic ulcer disease, gastroesophageal reflux disorder (GERD), or irritable bowel syndrome (IBS), as well as those who have undergone surgery related to these conditions 9.Have any other neurodegenerative diseases, mental illness or dementia 10.Any other clinical condition in the judgment of investigator finds the study participation unsuitable for the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes are as follows- 1.Changes in perceived stress scale (PSS) score, the short-form Nepean Dyspepsia Index (NDI),COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score, Assessing Gut health using a Gastrointestinal Symptom Rating Scale (GSRS) score 2.Time in seconds for relief from pain and heartburn in 5-10 subjects recommended to be used on a need basis in case of acid reflux flare/heartburn 3.Change in STAI (State-Trait Anxiety Inventory) score, Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance b. Depression),gut microbiota. 4.Change in serum cortisol levels 5.Changes in symptom score on a 7-point Likert scale to grade overall symptoms of dyspepsia.Timepoint: 1.Screening, day 30 and day 60 2.Screening, day 30 and day 60 3.Screening and day 60 4.Screening, day 15 and day 60 5.Screening, day 15, 30 and day 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are as follows-1.Assessment of adverse events, treatment compliance and tolerability of investigational products, changes in vital sign parameters. 2.Assessment of changes in complete blood count, liver function test and kidney function testTimepoint: 1.Screening, baseline, day 15, day 30, day 60 2.Screening and day 60 | — |
Countries
India
Contacts
Public ContactDr Kriti Soni
Herbolab India Pvt. Ltd.
Outcome results
None listed