Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Intervention1: LS/24-25/Gut001: 1 tablet twice a day for 60 days
Intervention2: LS/24-25/Gut002: 1 tablet twice a day for 60 days
Control Intervention1: Placebo: 1 tablet twice a day for 60 days
Sponsors
Life Synergy
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males and females aged 20-50years, with an equal gender distribution (both inclusive); 2.Participants must report one or more gut health-related symptoms, indicated by a GSRS score of 3 to 5 or a BSFS score of 1 to 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.3.Participants in whom loose stools are rarely present without the use of laxatives;4.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;5.Participants should agree to undergo Liver Function Tests and C-reactive protein assessments;6.Willingness to undergo baseline and follow-up assessments of gut health using the GSRS;7.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, 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 e.g. 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 1 or 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. Assessing Gut health using a Gastrointestinal Symptom Rating Scale GSRS score. 2. Patient Assessment of Upper Gastrointestinal Symptom Severity Index PAGI SYM Assessment of symptoms such as heartburn, nausea, and bloating. 3. Changes in body weight. 4. Gastrointestinal Quality of Life Index GIQLI Measurement of the impact of digestive symptoms on overall quality of life, including energy, fatigue, and well being will be measured 5. Stool Consistency and Frequency: Bristol Stool Form Scale BSFS Evaluating stool consistency. Frequency of Bowel Movements Self reported daily bowel movements recorded using a bowel diary.Timepoint: 1. At screening, day 30 and day 60. 2. From baseline to end of the study. 3. From baseline to end of the study. 4. At baseline and end of the study. 5. From baseline to end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of adverse events 2. Assessment of treatment compliance and tolerability of investigational products. 3. Assessment of changes in vital sign parameters. 4. Assessment of changes in complete blood count, liver function test and kidney function test.Timepoint: 1. From baseline to end of the study. 2. Throughout the study. 3. Throughout the study. 4. At screening and end of the study. | — |
Countries
India
Contacts
Public ContactDr Vaishnavi Patil
Life Synergy
Outcome results
None listed