FindTrial
Sign In

A study to see the effectiveness of semi solid mass in,reducing gastric problems and constipation.

An open label, double arm,study to determine efficacy of LeFiber mixed with water,in regularizing bowel movements, reducing constipation and enriching gut flora as compared to Psyllium husk as soluble fiber.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013078
Enrollment
70
Registered
2018-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Functional Constipation

Interventions

Intervention1: LeFiber 15 gm twice a day orally mixed with water for 15 days: It is a semi-solid having both, soluble and insoluble fibers in it Control Intervention1: Psyllium Husk 4.7 gm twice a da

Sponsors

Phytabolites Neutraceuticals Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1.To see efficacy of LeFiber in regularizing bowel movements as compared to Psyllium husk 2.To see efficacy of LeFiber in enhancing gut flora and quality of life as compared to Psyllium husk 3.To compare the overall effects of LeFiber and Psyllium husk after 7 and 15 days of discontinuing them Timepoint: Telephonic follow-up at 7th and 22nd day and Clinical follow-up at 15th and 30th day—

Countries

India

Contacts

Public ContactDr Sharvari Rangnekar

Quest Clinical Services

questclinicalservices@gmail.com9890229919

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026