CTRI/2025/12/099275CompletedNot Applicable
A randomized, double-blind, placebo-controlled, parallel-arm clinical trial to evaluate the efficacy and safety of chilli ginger extract in improving gut health.
Mane Kancor Ingredients Pvt. Ltd. Angamaly, Kerala 6835731 site in 1 country30 target enrollmentStarted: December 26, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
Study Overview
Brief Summary
Functional gastrointestinal disorders (FGIDs) are common conditions that affect digestive comfort, gut motility, and overall well-being. Many individuals experience symptoms such as bloating, abdominal discomfort, and irregular bowel habits, often without identifiable structural abnormalities. Current management options provide limited long-term relief, leading to growing interest in safe, food-based approaches that support digestive health.
This study is designed to evaluate the safety and efficacy of a natural, standardized formulation intended to support gut comfort and digestive function in adults with FGID-related symptoms. The trial will assess gastrointestinal outcomes, patient-reported symptoms, and overall well-being over the intervention period. The findings are expected to contribute to evidence supporting non-pharmacological strategies for general digestive health.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Males and females aged 20-45 years (both inclusive)
- •Participants with no history of specific diet or medication intake that could interfere with metabolic homeostasis and gut microbiota, including but not limited to oral or intravenous antibiotics, probiotics, or other microbiota-altering supplements within three months prior to recruitment.
- •Trial participants in normal health as determined by personal medical history and clinical examination including vital signs.
- •Participants willing and able to maintain a habitual, balanced diet throughout the study period and providing voluntary, written informed consent to participate in the study.
Exclusion Criteria
- •Participants with a diagnosis of colonic inertia.
- •Participants with a history of surgical interventions within the last six months.
- •History of anorectal surgery.
- •Participants diagnosed with functional gastrointestinal disorders, including Functional Constipation, Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), or chronic diarrhea.
- •Participants with structural abnormalities such as rectal prolapse, rectocele, or anorectal stricture.
- •Participants with untreated or uncontrolled systemic conditions and comorbidities.
- •A medical history of hypothyroidism, Grade 2 obesity, morbid obesity, or constipation associated with premenopausal or postmenopausal status.
- •Participants using antibiotics, probiotic products, herbal supplements, dietary fiber, or phytonutrient supplements.
- •Participants following an abnormal or restrictive dietary pattern (e.g., low sodium, fasting, ketogenic, or high-protein diets) during the four weeks preceding enrollment or unwilling to maintain a normal, balanced diet during the study period.
- •Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study.
- •Participants with a history of substance abuse or heavy use of alcohol and drugs or tobacco use, where participants smoke more than 1/2 pack per day.
Investigators
Dr Mandar Doiphode
Sangvi Multispeciality Hospital
Study Sites (1)
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