Health Condition 1: null- Adult male and female patients suffering from constipation. Health Condition 2: K590- Constipation
Conditions
Interventions
Intervention1: SoEazy: Each 4.8 grams of SoEazy is to be taken once daily preferably after dinner with 150 ml of water for 12 days. Immediate consumption after stirring it for 30 seconds.
Control Inte
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients suffering from constipation. 2 Constipation as defined by the American College of Gastroenterology : Unsatisfactory defecation characterized by infrequent stools, difficult stool passage, or both. 3 Difficult stool passage includes straining, a sense of difficulty passing stool, incomplete evacuation, hard/lumpy stools, prolonged time to stool. 4 Men and non-pregnant women 18 to 60 years of age. 5 Willing to give written informed consent. 6 Patient who is able and willing to complete questionnaire. 7 Having stool form between 1 to 3 on the Bristol Stool Form Scale.
Exclusion criteria
Exclusion criteria: 1 Patients with known or suspected history of hypersensitivity to the Investigational Product. 2 Patients with known history of colorectal cancer, anal abscess, anal fistula, anal fissure, rectocele, inflammatory bowel diseases, or gastro intestinal obstruction. 3 Patients with a known history of diabetes, hypertension, hypothyroidism, or any other metabolic disorders. 4 Patients with unknown cause of gastro intestinal bleeding, or acute infection. 5 Patients with symptoms of appendicitis or recent intestinal surgery. 6 Patients whose chronic constipation, according to the Investigator clinical judgement, is thought to be a result of bowel surgery, gynaecological surgery, neurologic disorders, systemic sclerosis, myloidosis, scleroderma, myotonic dystrophy. 7 Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Bristol Stool Chart. 2 Constipation assessment scale. 3 Patient assessment of Constipation symptoms. 4 Constipation clinical symptoms questionnaire. 5 Patient assessment of Constipation Quality of Life. 6 Clinical global improvement rating scale.Timepoint: 1 Bristol Stool Chart(All visits-Screening,Day0,Day3,Day6 & Day12) 2 Constipation assessment scale(All Visits) 3 Patient assessment of Constipation symptoms(All visits) 4 Constipation clinical symptoms questionnaire(All visits) 5 Patient assessment of Constipation Quality of Life(All visits) 6 Clinical global improvement rating scale(Day3,Day6 & Day12) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Adverse Events. 2 Laboratory parameters. 3 Vital signs.Timepoint: 1 Adverse Events (Visit2, Visit3 & Visit4). 2 Laboratory parameters (Screening & Visit 4). 3 Vital signs (Screening, Visit2, Visit3 & Visit 4). | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
ClinWorld Private Limited
Outcome results
None listed