Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Intervention1: Group A: Prebiotic Colon Detox Shots: 70ml to be taken first thing in the morning on an empty stomach for 14 days.
Control Intervention1: Group B: Placebo: 70ml to be taken first thing
Sponsors
Seven Turns Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males and females aged 20-45 years, with an equal gender distribution (both inclusive);2.Female participants will be screened within 2 days of completion of the menstrual phase (bleeding phase). A 7-day screening period will follow to ensure eligibility. Treatment will begin immediately after the screening period is completed. 3.Participants must report one or more gut health-related symptoms, indicated by a GSRS score of 3-5 or a BSFS score of 1-3. Eligible symptoms include:�Bloating �Abdominal discomfort or pain �Infrequent bowel movements (fewer than three defecations per week) �Hard or lumpy stools (types 1 to 3 on the Bristol Stool Form Scale) �Sensation of incomplete evacuation during defecation.4.Participants in whom loose stools are rarely present without the use of laxatives;5.Participants on stable medication for the past three months (with no worsening of symptoms or hospitalization) are eligible, or may be enrolled at the discretion of the investigator;6.Participants should agree to undergo Liver Function Tests and C-reactive protein assessments;7.Willingness to undergo baseline and follow-up assessments of gut health using the GSRS;8.Participants 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, including HIV or diabetes mellitus or tuberculosis; 7.Participants with renal or liver dysfunction; 8.Participants with neurological disorders, such as Parkinsons disease or multiple sclerosis; 9.A medical history of hypothyroidism, Grade 2 obesity, morbid obesity, or constipation associated with premenopausal or postmenopausal status; 10.Participants currently using laxatives, antacids, proton pump inhibitors, antibiotics, or other probiotic products; 11.Participants using herbal supplements, dietary fiber, or phytonutrient supplements; 12.Participants will be excluded if they have initiated new micronutrient supplements eg iron, zinc within the past 14 days; 13.Participants who have undergone colonic cleansing in the last three months; 14.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study; 15.Participants with a history of substance abuse or heavy use of alcohol and drugs or tobacco use, where participants smoke more than 1or 2 pack per day; 16.Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gastrointestinal Symptom Rating Scale GSRS Assessment of symptoms including bloating, abdominal pain, diarrhea, and constipation, abdominal discomfort using a 7 Likert scale Up to three loose stools or bathroom visits per day will be recorded as no to minor discomfort on the GSRS. If the number of loose stools or visits exceeds three, the severity of discomfort will be assessed and scored at the discretion of the investigator. 2. Stool Consistency and Frequency a. Bristol Stool Form Scale BSFS Evaluating stool consistency b. Frequency of Bowel Movements Self-reported daily bowel movements recorded using a bowel diary 3. Time of Evacuation Documenting the duration of each bowel movement using a bowel diary Timepoint: 1. At day 1, day 4, day 8, and day 15. 2. a. At screening, day 1, day 4, day 8, and day 15. b. At day 1, day 4, day 8 and day 15. 3. At day 1, day 4, day 8, and day 15. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives will be to evaluate the impact of prebiotic colon detox shots on detoxification, and systemic inflammation related to gut health, digestive function, and quality of life. Additionally, the study will assess safety through monitoring adverse events, tolerability, and compliance throughout the study duration. Timepoint: From Screening to end of the study. | — |
Countries
India
Contacts
Public ContactKaynat Mirajkar
Seven Turns Pvt. Ltd.
Outcome results
None listed