CTRI/2012/09/002954已完成2 期
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:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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
研究者
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