Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: LactiliqTM Syrup (Lactitol and Bascillus Coagulance SC208)
: Patients will receive 15 ml Lactitol Syrup once daily for 4 weeks.
Control Intervention1: Not applicable: Not applicable
Co
Sponsors
Synergia Life Sciences Pvt Ltd
Siro Clinpharm Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients both males and females, between 18-65 years of age. 2. Patients who are known cases of Chronic Idiopathic Constipation (CIC) defined by Rome III diagnostic criteria Rome III defines functional constipation or chronic idiopathic constipation as the presence of two or more of the following for more than 6 months: a. Straining during at least 25% of defecations. b. Lumpy or hard stools in at least 25% of defecations. c. Sensation of incomplete evacuation for at least 25% of defecations. d. Sensation of anorectal obstruction/blockage for at least 25% of defecations. e. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor). f. Fewer than three defecations per week. 3. Patients on stable medications (past 3 months) in case suffering from Diabetes Mellitus Type II. 4. Patients willing to abide by study procedures and provide voluntary written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone major abdominal surgery. 2. Patients with concomitant diseases such as Gastrointestinal diseases and/or medical or psychiatric illness. 3. Patients with family history of peptic ulcer, colorectal cancer or IBD. 4. Patients with a documented history of slow colonic transit. 5. Patients with abnormal laboratory data ( i.e. with liver enzymes (ALT and AST) more than 3 times ULN1 and/or bilirubin more than 1.5 times ULN1). 6. Patients with history of hypothyroidism or abnormal thyroid function. 7. Patients with history of renal impairment or abnormal renal function test ( i.e. Serum creatinine more than 2 times ULN1). 8. Any other laboratory value abnormality considered clinically significant by the Investigator. 9. Patients who participated in any clinical trial in the past 90 days. 10. Patients who have received any probiotic formulation in the past 30 days. 11. Patients with known or expected hypersensitivity to any of the active substances or excipients. 12. Patients who are pregnant or lactating. 13. Patients who are allergic or atopic to any of the ingredients of the study medication. 14. Patients suffering from any other medical condition in opinion of the Investigator that may put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patients participation in the study. 15. Patients with use of any prescription and/ or OTC laxatives during the 48 hour period prior to the first dose of study medication. 16. Disease assessment score of more than or equal to 15 with constipation scoring system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success (defined as 3 or more spontaneous stools per week).Timepoint: Day 29. | — |
Secondary
| Measure | Time frame |
|---|---|
| A) Treatment success (defined as 3 or more spontaneous stools per week) at Day 8, 15 B) Change in category according to Bristol scale for stool passage from baseline to Day 8, 15 and 29 in: i) Stool frequency (Constipation Scoring System [CSS] scale) ii) Difficulty degree of defecation-sensation of incomplete evacuation (Constipation Scoring System [CSS] scale). iii) Defecation pain (Constipation Scoring System [CSS] scale). iv) Abdominal Pain (Constipation Scoring System [CSS] scale). C) Change from baseline to Day 8, 15 and 29 for: i) Evaluation Questionnaire in patients with constipation ii) Abdominal gas iii) BloatingTimepoint: Day 8, 15 & 29 | — |
Countries
India
Contacts
Public ContactDr Shashank S Jadhav
SIRO Clinpharm Pvt. Ltd.
Outcome results
None listed