A Clinical evaluation of TLPL/AY/01/2008 in the Management of Chronic Constipation arising from an unknown cause

Recruitment & Eligibility

Inclusion Criteria

1. Subjects presenting with two or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis

a. Straining during at least 25% of defecations

b. Lumpy or hard stools at least 25% of defecations

c. Sensation of incomplete evacuation at least 25% of defecations

d. Sensation of anorectal obstruction/blockage 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

2. Subjects in whom loose stools are rarely present without the use of laxatives

3. Subjects not meeting Rome diagnostic criteria for IBS

4. Subjects in the age group of 18 to 70 years

5. Subjects having stool form between 1 to 3 on the Bristol Stool Form Scale

6. Willingness to sign informed consent document and to comply with the protocol.

Exclusion Criteria

1. Subjects with diagnosed colonic inertia.

2. Subjects who have recently undergone abdominal surgery

3. Subjects with history of anorectal surgery.

4. Subjects having other functional gastrointestinal disorders other than Functional constipation i.e. IBS, Belching disorders etc.

5. Subjects diagnosed with structural abnormalities, like:

i.Anorectal: rectal prolapse, rectocele, rectal intussusceptions,

anorectal stricture, solitary rectal ulcer syndrome

ii.Perineal descent

iii.Colonic or rectal mass or tumor with obstruction e.g.

adenocarcinoma

iv.Colonic stricture: radiation, ischemia, diveticulosis

v.Intestinal obstruction

6. Subjects with serious uncontrolled & diagnosed systemic ailments like HIV, DM and Tuberculosis.

7. Subjects with renal or liver dysfunction

8. Subjects with diagnosed neurological problems like,

vi.Parkinsons disease

vii.Multiple sclerosis

viii.Sacral nerve damage for example prior pelvic surgery, tumor

ix.Paraplegia

x.Autonomic neuropathy

9. Pregnant or lactating females

10. Subjects not willing to sign informed consent form

11. Subjects allergic or atopic to any of the ingredients of the study medication

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of TLPL/AY/01/2008 in <br/ ><br>subjects with Functional Constipation by assessing, <br/ ><br>1.Changes in frequency of bowel movements <br/ ><br>2.Changes in stool form assessed by Bristol <br/ ><br>stool form scaleTimepoint: Every Week till Three Week

Secondary Outcome Measures

Name	Time	Method
1. Changes in scores of other symptoms of functional constipation <br/ ><br>2. Changes in associated clinical symptoms of <br/ ><br>Functional Constipation. <br/ ><br>3. Global assessment for overall improvement by <br/ ><br>the Physician & by Patient. <br/ ><br>4. Tolerability of the trial drug in patient with <br/ ><br>functional constipation <br/ ><br>5. Laboratory parametersTimepoint: Every Week till Three Week