Not Yet RecruitingNot Applicable

A Study to Assess the Effect of the Natural Orange Extract in Individuals With Gastrointestinal Discomfort

India64 participantsStarted 2024-10-15

Plain-language summary

A Randomized, Double-Blind, Two-Arm, Placebo-Controlled Clinical Study to assess the Effect of the Natural Orange Extract in Individuals with Gastrointestinal Discomfort

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Individuals willing to give written informed consent form voluntarily to participate in the study
✓. Healthy males and females of age between 18-65 years.
✓. Individuals with a Body Mass Index (BMI) between 18.5-29.9 kg/m2 (both values included).
✓. Individuals with a history of GI discomfort, associated with changes in the frequency and form of stools for the last 3 months, with symptom onset at least 6 months.
✓. Individuals with complaints of loose or watery stools, occurring in more than 25% of stools for the last 3 months.
✓. Individuals with consistent and stable body weight in the last 3 months prior to screening (less than 5% self-reported change).
✓. Individuals with a baseline score of less than or equal to 55 for the digestive domain score of the Gastrointestinal Quality of Life Index (GIQLI).
✓. Individuals with Fasting Blood Glucose (FBG) less than equal to 125 mg/dl.

Exclusion criteria

✕. Individuals diagnosed with diabetes mellitus and are on active medication.
✕. Individuals diagnosed with hypertension and are on active medication.
✕. Individuals with thyroid dysfunction as assessed by Thyroid Stimulating Hormone (TSH) less than or equal to 0.4 or more than or equal to 5.0 mIU/L will be excluded.
✕. Individuals with a history and/or presence of acute or chronic significant GI disease or digestion/absorption disorders (e.g., Irritable bowel syndrome, inflammatory bowel disease, infectious diarrhea, coeliac disease, Clostridium difficile colitis, malabsorption, pancreatitis, disorders in digestive tract motility, gluten enteropathy, etc).
✕. Individuals with a history of autoimmune disorders.
✕. Individuals with major gastric, hepatic, biliary, pancreatic, or intestinal surgery within the last 6 months prior to screening or planned during the study (appendectomy, haemorrhoidectomy, or polypectomy allowed as long as occurred more than 3 months prior to screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred more than 3 months prior to screening).
✕. Any other relevant serious organ or systemic diseases (e.g., cardiovascular, respiratory, liver, renal, neurological disease, etc).
✕. Individuals with a history of malignancy within last five years.

What they're measuring

To assess the effect of the IP on gastrointestinal digestion symptoms as assessed by the change in digestive domain scores of the Gastrointestinal Quality of Life Index (GIQLI) compared to baseline and placebo.

Timeframe: Day 0, Day 45, Day 90.

Trial details

NCT IDNCT06658717

SponsorVedic Lifesciences Pvt. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-15

Contact for this trial

Dr. Sanjay Vaze, MBBS

8655670964 sanjay.v@vediclifesciences.com

View on ClinicalTrials.gov More Gut Health trials