To evaluate efficacy of Elleâ??s UdarSudha an Ayurvedic drug, in patients with functional Dyspesia with or without Irritable bowel syndrome

A parallel group, randomized, single blind, placebo controlled, phase IV study to establish safety and efficacy of Elleâ??s UdarSudha RasÂ® in patients with functional gastrointestinal dissorders (FGID) with and without irritable bowel syndrome (IBS) - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055451

Enrollment

Registered

2023-07-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Health Condition 1: K30- Functional dyspepsia Health Condition 2: K582- Mixed irritable bowel syndrome

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient who are willing to give written consent and complete knowledge about the study 2.Being diagnosed with FD based on the ROME III criteria as the presence of postprandial distress syndrome (PDS) (including postprandial fullness or early satiation) and epigastric pain syndrome (EPS) (including epigastric pain, or epigastric burning), for three months in the past six months. Dyspepsia symptoms with scores of 6 or higher on the 9-point Numerical Rating Scale (NRS) for more than 4 of the 14 days prior to registration will be included in the study. 3, Patients suffering from Irritable bowel syndrome as per Rome III criteria

Exclusion criteria

Exclusion criteria: 1. Patients below 18 and above 65 years 2. Patients with Ulcerative colitis and Crohns disease 3. Pregnant and lactating women. 4. Patients with laboratory abnormalities with hemoglobin 120 IU/L, serum creatinine >1.5 mg/ dl, occult blood in stool, and increased CRP will be among the exclusion criteria 5.Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. 6. Subject with clinically significant abnormal vital sign or laboratory value that precludes participation.

Design outcomes

Primary

Measure	Time frame
improvement in Total Symptom Score of Functional Dyspepsia symptoms score and Irritable bowel syndrome score to the end of 8 weeks of treatmentTimepoint: 8 weeks	—

Secondary

Measure	Time frame
Functional Gastro Intestinal Disorder related Quality of Life scale improvementTimepoint: 4 & 8 weeks	—

Countries

India

Contacts

Public ContactDr Sudheendra A Deshpande

Phytoinc Divya Jyothi Clinic

drsudheendra@gmail.com9686554464

Outcome results