An Open Label, Prospective Clinical Study to Evaluate the Efficacy and Safety ofTLPL/AY/01/2008 in the Management of Functional Constipation - None

Tulip Lab Pvt Ltd0 个研究点目标入组 25 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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.

•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

发起方

Tulip Lab Pvt Ltd