None listed
Conditions
Interventions
Intervention1: Group A: one 5 g sachet containing 2.5 g of Chilli Ginger Extract powder, administered orally twice daily (morning and evening) after meals, dissolved in 100 mL of water, for a duration
Sponsors
Mane Kancor Ingredients Pvt. Ltd. Angamaly, Kerala 683573
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females aged 20-45 years (both inclusive) 2. 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. 3. Trial participants in normal health as determined by personal medical history and clinical examination including vital signs. 4. 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
Exclusion criteria: 1. Participants with a diagnosis of colonic inertia. 2. Participants with a history of surgical interventions within the last six months. 3. History of anorectal surgery. 4. Participants diagnosed with functional gastrointestinal disorders, including Functional Constipation, Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), or chronic diarrhea. 5. Participants with structural abnormalities such as rectal prolapse, rectocele, or anorectal stricture. 6. Participants with untreated or uncontrolled systemic conditions and comorbidities. 7. A medical history of hypothyroidism, Grade 2 obesity, morbid obesity, or constipation associated with premenopausal or postmenopausal status. 8. Participants using antibiotics, probiotic products, herbal supplements, dietary fiber, or phytonutrient supplements. 9. 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. 10. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study. 11. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessing Gut health using a Gastrointestinal Symptom Rating Scale (GSRS) score. 2. Stool Consistency and Frequency: Bristol Stool Form Scale (BSFS): Evaluating stool consistency.(A BSFS chart will be provided to the participant for reference). Frequency of Bowel Movements: Self-reported daily bowel movements recorded using a bowel diary. Time of Evacuation: Documenting the duration of each bowel movement using a bowel diary. 3. Gut microbiome modulation by studying whole-genome shotgun metagenomic sequencing of stool samples. 4.Short chain fatty acid analysis in the stool samples.Timepoint: 1. at baseline, day 14, and 28 2. at baseline, day 14, and day 28 3. baseline and day 28 4. baseline and day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events Gastrointestinal symptoms occurring on non-visit days will be recorded as anticipated adverse events. Non-GI adverse events will be recorded daily. All adverse events will be documented in the adverse event section of the case report form (CRF). 2. Compliance will be assessed. 3. Tolerability of the investigational product. Timepoint: 1. at baseline, day 14, and day 28. 2. at day 28. 3. at day 14 and day 28. | — |
Countries
India
Contacts
Public ContactDr Sherena PA
Mane Kancor Ingredients Pvt Ltd
Outcome results
None listed