To evaluate the effect of Laxirid syrup in the management of constipatio
- Conditions
- Health Condition 1: K590- Constipation
- Registration Number
- CTRI/2018/02/012110
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Any improvement or relief from clinical symptoms related to the acidity or by the resolution of symptoms which ever stands earlyTimepoint: At the end of 2 weeks and 4 weeks
- Secondary Outcome Measures
Name Time Method The clinical global response by physician and the subject in overall improvementTimepoint: At the end of study