A study to see the effectiveness of semi solid mass in,reducing gastric problems and constipation.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Functional Constipation
- Registration Number
- CTRI/2018/04/013078
- Lead Sponsor
- Phytabolites Neutraceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
1.Patients fulfilling the Rome III Diagnostic Criteria for Functional Gastrointestinal Disorder- C3 (section for functional constipation) and/or taking frequent laxatives
2.Age between 18 years to 80 years of either gender
3.Consenting
Exclusion Criteria
1.Constipation of drug induced or secondary to endocrine, metabolic or neurological disorders, surgery, known or suspected organic disorders of large intestine or colon cancer
2.Pregnant or breast-feeding woman
3.Patient with acute conditions like Appendicitis
4.Uncontrolled cardiovascular, kidney, liver or lung diseases; Epilepsy
5.H/o any significant weight loss, H/o blood mixed in stools
6.Patients having incontinence
7.Participant of other clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study if there is reduction in constipation with LeFiber as compared to psyllium huskTimepoint: Telephonic follow-up at 7th and 22nd day and Clinical follow-up at 15th and 30th day
- Secondary Outcome Measures
Name Time Method 1.To see efficacy of LeFiber in regularizing bowel movements as compared to Psyllium husk <br/ ><br>2.To see efficacy of LeFiber in enhancing gut flora and quality of life as compared to Psyllium husk <br/ ><br>3.To compare the overall effects of LeFiber and Psyllium husk after 7 and 15 days of discontinuing them <br/ ><br>Timepoint: Telephonic follow-up at 7th and 22nd day and Clinical follow-up at 15th and 30th day