A Study to Evaluate Efficacy of Different Natural Ingredients in Improving Gut Health in Adults With Leaky Gut.

Last updated: June 14, 2024
Sponsor: Vedic Lifesciences Pvt. Ltd.
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

TSH-GH-03

MK-GH-04

PA-GH-01

Clinical Study ID

NCT05952232
EB/230301/TPEKC/LG
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The present study is a randomized, placebo-controlled, double-blind, parallel group study to assess the gut health effects of IP as compared to a placebo in overweight individuals experiencing gut issues. Approximately 20 participants aged between 18 and 65 years will be screened for each group. All the five arms of the IP and placebo trial arms will each have at least 10 completed participants after accounting for the screening failure and dropout/withdrawal rate of 20% each. The treatment duration for all the study participants will be 29 days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female individuals with the age ≥18 and ≤65 years with moderate physicalactivity level as per International Physical Activity Questionnaire - Short Form (IPAQ-SF)

  • Body mass index > 18 and < 29.9 kg/m2

  • Individuals with at least once/ week complains of ≥ 3 of following gastrointestinalsymptoms since last three months: dyspepsia, diarrhea, constipation, heartburn,nausea, acid reflux, bloating.

  • Individuals agreeing to consume four tablets (325 mg each) of aspirin twice within a 12-hour period

  • Individuals with fasting blood glucose levels ≤ 125 mg/dL

  • Individuals with availability of western toilet at their homes for stool samplecollection

  • Individuals who are literate enough to understand the essence of study, are informedabout the purpose of the study, and understand their rights.

  • Individuals who are able to give written informed consent and are willing toparticipate in the study.

Exclusion

Exclusion Criteria:

  • Individuals diagnosed with IBS including IBS-Constipation, IBS-Mixed, IBS-Diarrheaor Unclassified

  • Allergy to aspirin

  • Use of medications in the last 2 weeks prior to the pre-baseline period. This doesnot include birth control pills or standard multi-vitamin/mineral supplements

  • Performing high intensity exercise regularly using IPAQ- SF

  • Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks priorto screening

  • Unwillingness to avoid the use of antidiarrheal or laxative medication on a regularor an "as-needed basis" during the full length of the study

  • Abnormal Thyroid Stimulating Hormone (TSH) value which is < 0.40 or > 4.50 μIU/mL

  • Individuals with uncontrolled type II DM defined as FBG > 125 mg/ dL

  • Presence of uncontrolled hypertension defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mmHg with or without anti-hypertensives

  • Individuals on high-fiber/ fodmap diet

  • Individuals with known diagnosis of helicobacter pylori infection

  • Individuals with a history of surgical resection of the stomach, small intestine orlarge intestine

  • Individuals with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis

  • Current smokers

  • Use of another investigational product within 3 months of the screening visit

  • History or current impaired cardiovascular circulation or uncontrolled hypertension,diabetes, bleeding tendencies, kidney, liver or chronic respiratory diseasesincluding asthma, or any other disease, that by the investigators' discretion couldinterfere with the intestinal barrier function of the subject

  • Individuals who used probiotics, prebiotics, antibiotics, prokinetics, laxatives,suppositories or enemas in the last 3 months

  • Individuals with a history of any diet-based intolerance (gluten or lactoseintolerance)

  • Individuals with a history of or complications from malignant tumors.

  • History of any significant neurological and psychiatric condition which may affectthe participation and inference of the study's end points.

  • Use of recreational drugs (such as cocaine, methamphetamine, marijuana,etc.)/Nicotine dependence.

  • High-risk drinking as defined by consumption of 4 or more alcohol containingbeverages on any day or 8 or more alcohol containing beverages per week for womenand 5 or more alcohol containing beverages on any day or 15 or more alcoholcontaining beverages per week for men

  • Individuals who have clinically significant following illness, i.e., Cardiovascular,endocrine system, immune system, respiratory system, hepatobiliary system, kidneyand urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood andtumors, other gastrointestinal diseases, etc

  • Females who are pregnant/planning to be pregnant/lactating or taking any oralcontraceptives

  • Any condition that could, in the opinion of the investigator, preclude theparticipant's ability to successfully and safely complete the study or that mayconfound study outcomes.

Study Design

Total Participants: 45
Treatment Group(s): 4
Primary Treatment: TSH-GH-03
Phase:
Study Start date:
August 17, 2023
Estimated Completion Date:
May 27, 2024

Connect with a study center

  • Dr. Kumta Mali's Clinic

    Mumbai, Maharashtra 400053
    India

    Site Not Available

  • Dr. Preeti Bawaskar's Clinic

    Thāne, Maharashtra 400607
    India

    Site Not Available

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