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Search / Trial NCT06568965

Clinical Study of De-Stress & Happy Gut Powder for Stress and Indigestion in Adults.

Launched by HERBOLAB INDIA PVT. LTD. · Aug 22, 2024

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Stress Dyspepsia Indigestion

ClinConnect Summary

This clinical trial is investigating a product called De-Stress & Happy Gut Powder, which is designed to help adults manage stress and symptoms of indigestion, like bloating and stomach discomfort. The goal is to see if this powder can improve gut health, which may lead to better nutrient absorption, increased energy levels, and enhanced emotional well-being. Participants will need to be between the ages of 21 and 50 and report experiencing mild to moderate stress and symptoms of functional dyspepsia, such as abdominal fullness or pain.

To participate in the study, individuals must be willing to sign a consent form and not have severe anxiety or depression. Those with a history of substance abuse or certain medical conditions that could interfere with the study will not be eligible. If you join the trial, you can expect to try the De-Stress & Happy Gut Powder and help researchers learn more about how it affects stress and digestion. It's important to note that the trial is not yet recruiting participants, so you will need to wait for it to start if you're interested.

Gender

ALL

Eligibility 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:
  • 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.

About Herbolab India Pvt. Ltd.

Herbolab India Pvt. Ltd. is a leading clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a strong focus on herbal and natural products, the company leverages its expertise to conduct rigorous clinical trials that ensure safety, efficacy, and compliance with regulatory standards. Herbolab is committed to fostering collaborations with healthcare professionals and research institutions, striving to enhance therapeutic options and improve patient outcomes. Through its comprehensive approach, Herbolab India Pvt. Ltd. plays a pivotal role in the evolution of evidence-based herbal medicine.

Locations

Patients applied

0 patients applied

Trial Officials

Dr. Ramshyam Agarwal, MBBS, DNB

Principal Investigator

Lokmanya Medical Research Centre and Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported