Health Condition 1: K580- Irritable bowel syndrome with diarrhea
Conditions
Interventions
Intervention1: Dipya IBS Care Tablet: One Dipya IBS Care Tablet two times in a day after food orally FOR 60 days.
Control Intervention1: NIL: NIL
Sponsors
Vedistry Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all the following criteria will be eligible for the study 1. Male and female participants aged 30-60 years both inclusive 2. Participants who are diagnosed based on Rome IV diagnostic criteria with either diarrhea predominant Irritable Bowel Syndrome IBS-D greater than one fourth of 25 percent of bowel movements with Bristol stool types 6 or 7 and less than one fourth of 25 percent of bowel movements with Bristol stool types 1 or 2 or IBS with mixed bowel habits IBS-M greater than one fourth of 25 percent of bowel movements with Bristol stool types 1 or 2 and greater than one fourth of 25 percent of bowel movements with Bristol stool types 6 or 7 For clinical trials IBS subtyping based on at least 2 weeks of daily diary data is recommended using the 25 percent rule 3. Participants experiencing recurrent abdominal pain on at least one day per week 4. At baseline visit before starting the intervention the following criteria must be met Diary completed on at least 5. Participants willing and able to provide signed informed consent form prior to any study related procedures 6. Participants able to swallow solid, oral dosage forms whole with the aid of liquid 7. Participants agreed to refrain from making any new major lifestyle changes that may have affected IBS symptoms e.g. starting a new diet or changing their exercise pattern from the time of signature of the informed consent form to the last study visit
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be eligible for the study 1. Participants with diagnosed other IBS subtypes inflammatory bowel disease colonic inertia 2. Participants with a BMI greater than 30 kg/m 3.Participants had a known or suspected structural abnormality of the gastrointestinal tract (e.g. mechanical gastrointestinal obstruction) or a disease or condition that could affect gastrointestinal motility; 4.Participants currently had clinically significant symptoms such as lower gastrointestinal bleeding (rectal bleeding or heme-positive stool), iron-deficiency anemia, weight loss or systemic signs of infection or colitis; 5.Participant had any chronic condition with ongoing symptoms that could be associated with abdominal pain or discomfort and could confound the assessments in the study (e.g. diverticulitis, ileus, active peptic ulcer disease, uncontrolled gastroesophageal reflux disease, gastroparesis, chronic pancreatitis, polycystic kidney disease, ovarian cysts, endometriosis, urological pain); 6.Participants who have undergone abdominal surgery including bariatric surgery, anorectal surgery; 7.Participants had a history of diabetic neuropathy; 8.Participants diagnosed with structural abnormalities, like anorectal: rectal prolapse, rectocele, rectal intussusceptions, anorectal stricture, solitary rectal ulcer syndrome, perineal descent, colonic or rectal mass or tumor with obstruction e.g. adenocarcinoma, colonic stricture: radiation, ischemia, diverticulosis intestinal obstruction; 9.Participants with serious uncontrolled & diagnosed systemic ailments like HIV, DM and Tuberculosis; 10.Participants with renal or liver dysfunction; 11.Participants with diagnosed neurological problems like, Parkinson s disease, multiple sclerosis, sacral nerve damage for example prior pelvic surgery, tumor, and paraplegia; Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in IBS Severity Scoring System (IBS-SSS) at screening, day 30, and day 60. (The questionnaire consists of 4 items referring to abdominal pain, bowel dysfunction, and general well-being). 2. Changes in Irritable Bowel Syndrome Quality of Life at screening, day 30 and day 60. 3. Changes in Gastrointestinal Symptoms Rating Scale- IBS (GSRS- IBS) at screening, day 30 and day 60. 4. Changes in stool evacuation frequency (time interval between two bowel movements) and consistency, assessed using the Bristol Stool Form Scale (BSFS) and recorded in a bowel diary at screening, day 30 and day 60. Timepoint: Screening, day 30 and day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of vital signs (heart rate and blood pressure) and physical examinations (weight) at screening, day 30, and day 60. 2. Assessment of adverse events at baseline, day 30, and day 60. 3. Assessment of hematological parameters (Complete Blood Count), renal function test, and liver function test at screening and day 60. 4. Assessment of treatment compliance and tolerability of investigational products at day 30 and day 60.Timepoint: Screening, baseline, day 30 and day 60 | — |
Countries
India
Contacts
Public ContactDr Manasi Maurya
Charak Pharma Pvt. Ltd
Outcome results
None listed