This is a single study wherein the efficacy and safety of SoEazy will be studied in adult male or female patients suffering from constipation.

Not Applicable

Completed

• Conditions: Health Condition 1: null- Adult male and female patients suffering from constipation.Health Condition 2: K590- Constipation

• Registration Number: CTRI/2016/08/007229
• Lead Sponsor: Sami Labs Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-08-12
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1 Patients suffering from constipation.

2 Constipation as defined by the American College of Gastroenterology : Unsatisfactory defecation characterized by infrequent stools, difficult stool passage, or both.

3 Difficult stool passage includes straining, a sense of difficulty passing stool, incomplete evacuation, hard/lumpy stools, prolonged time to stool.

4 Men and non-pregnant women 18 to 60 years of age.

5 Willing to give written informed consent.

6 Patient who is able and willing to complete questionnaire.

7 Having stool form between 1 to 3 on the Bristol Stool Form Scale.

Exclusion Criteria

1 Patients with known or suspected history of hypersensitivity to the Investigational Product.

2 Patients with known history of colorectal cancer, anal abscess, anal fistula, anal fissure, rectocele, inflammatory bowel diseases, or gastro intestinal obstruction.

3 Patients with a known history of diabetes, hypertension, hypothyroidism, or any other metabolic disorders.

4 Patients with unknown cause of gastro intestinal bleeding, or acute infection.

5 Patients with symptoms of appendicitis or recent intestinal surgery.

6 Patients whose chronic constipation, according to the Investigator clinical judgement, is thought to be a result of bowel surgery, gynaecological surgery, neurologic disorders, systemic sclerosis, myloidosis, scleroderma, myotonic dystrophy.

7 Pregnant or lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified