An open comparative randomized clinical studyto evaluate the efficacy of JLN/PP/107 an herbal laxativein the management of functional Constipation

Dabur India Limited0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Subjects presenting with two or more of the following for at least 12 weeks ( not necessary consecutive) in the preceding 12 months (the Rome II criteria):
•1.1 Straining at defecation more than 25% of bowel movements
•1.2 Lumpy or Hard Stools more than 25% of bowel movements
•1.3 Sensation of incomplete evacuation for more than 25% of bowel movements
•1.4 Sensation of ano-rectal blockage for more than 25% of bowel movements
•1.5 Manual maneuvers two facilitate more than 25% of bowel movements
•1.6 less than 3 bowel movements per week.
•2. Willingness to sign informed consent and to come for regular follow up examinations as & when required.

•1.Patient with diagnosed colonic inertia.
•2.Patients with history of ano rectal surgery.
•3.Patients with structural abnormalities, like:
•3.1 Ano rectal: rectal prolapsed, rectocele, rectal intussuception, anorectal stricture, solitary rectal ulcer syndrome.
•3.2 Perineal descent
•3.3 Colonic/ rectal mass or tumor with obstruction e.g. adenocarcinoma
•3.5 Colonic stricture; radiation, ischemia, diveticulosis
•3.6 Hirschsprungâ??s disease
•3.7 Idiopathic megarectum
•3.8 Intestinal obstruction
•4.Patients with diagnosed neurological problems like,Parkinsonâ??s disease, Multiple Sclerosis
•Sacral nerve damage (prior pelvic surgery, tumor),Paraplegia,Autonomic neuropathy.
•5.Patients with serious systemic ailments like HIV, DM and tuberculosis
•6.Pregnant or lactating females
•7.Patient with renal or liver dysfunction
•8.Patient not willing to sign informed consent
•9.Patient not willing to come for follow up when required
•10.Patient on chronic medication (more than 60 days) and/or who are on medications known to cause constipation.

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