CTRI/2022/09/045755已完成4 期
A Randomized, Double-Blind, Active-Controlled, 4-week Parallel GroupStudy to Evaluate the Efficacy and Safety of Lactitol and Probiotic Bacillus Coagulans SC208 in patients with Chronic Idiopathic Constipation. - Lactiliq-TM Syrup
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients both males and females, between 18-65 years of
- •2. Patients who are known cases of Chronic Idiopathic
- •Constipation (CIC) defined by Rome III diagnostic
- •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.
排除标准
- •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.
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