None listed
Conditions
Interventions
Intervention1: CL18100F4-500mg: one capsule daily after dinner for 14 days
Intervention2: CL18100F4-300mg: one capsule daily after dinner for 14 days
Control Intervention1: Placebo: one capsule daily
Sponsors
CLS Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: •Male and female subjects aged between 25 and 60 years with BMI of 20 to 29 kg/m2. •Subjects meet the following Rome-III diagnostic criteria for Functional constipation: i.Must include two or more of the following: 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 ii.Loose stools are rarely present without the use of laxatives iii.There are insufficient criteria for irritable bowel syndrome. (NOTE: Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis) •Female subjects of childbearing potential must be using a medically acceptable form of birth control. Post-menopausal subjects must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. •Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent. •Subjects agree to be available for regular follow up throughout the study duration. •Subject considered generally healthy as per health history and routine clinical investigations during screening.
Exclusion criteria
Exclusion criteria: •Subjects with secondary constipation (caused by medical condition or medication use). •Subject using drugs or supplements for gastrointestinal motility or laxatives. •Subject using dietary supplements like prebiotics or probiotics. •Subjects with history of medical conditions like cerebrovascular disease, depression, hypothyroidism, Irritable bowel syndrome or taking medicines like Antacids, Iron supplements, Opioids etc. •Subjects underwent treatment for COVID 19 or tested positive during the study will be excluded. •Women who are pregnant, lactating or planning to become pregnant during the study duration. •Subjects with any disease or abnormalities related to gastrointestinal tract, pancreas and liver. •Subjects with controlled hypertension and diabetes. •Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies. •Subjects consuming alcohol or smokers. •History of psychiatric disorder that may impair the ability of subjects to provide written informed consent. •Expectation of any surgery during the study period. •Subject who participated in a clinical study within the last 30 days prior to recruitment or currently participating in another study. •Subjects with a known allergy or sensitivity to herbs/spices/plant products in general and/or allergic to botanical ingredients contained in the study product. •Any other condition that, in the opinion of the investigator, would adversely affect the subjectâ??s ability to complete the study or its measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to end of the study period in Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaireTimepoint: Day 1, Day 7 & Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to end of the study period in Complete spontaneous bowel movement (CSBM)Timepoint: Day 1, Day 7 & Day 14;Change from baseline to end of the study period in Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) Timepoint: Day 1 & Day 14;Change from baseline to end of the study period in Physician/Patient global assessment (PGA)Timepoint: Day 1, Day 7 & Day 14;Change from baseline to end of the study period in Questionnaire related to GITimepoint: Day 1, Day 7 & Day 14;Change from baseline to end of the study period in Serum BiomarkersTimepoint: Day 1 & Day 14;Change from baseline to end of the study period in Use of rescue medication (Laxative)Timepoint: Day 1, Day 7 & Day 14;Change from baseline to end of the study period in Victoria Bowel performance scale (BPS)Timepoint: Day 1, Day 7 & Day 14;Change from baseline to end of the study period in Questionnaire related to stress and sleepTimepoint: Day 1, Day 7 & Day 14;Change from baseline to end of the study period in Quality of life questionnaire (SF-36)Timepoint: Day 1 & Day 14 | — |
Countries
India
Contacts
Public ContactMr Ajjarapu Srinivasu
CLS Pvt Ltd
Outcome results
None listed