Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2016/09/007292
CTRI/2016/09/007292
Completed
Phase 4

Assessment of Efficacy, Tolerability and Safety of Cremalax® (Na Picosulphate 10mg) in Bowel Preparation Needed in Patients Undergoing Gastrointestinal OR Ano-rectal Surgery: A Prospective, Non-Comparative Study

VYAS SURGERY0 sites100 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHealth Condition 1: null- Patients requiring bowel preparation for gastrointestinal or anorectal surgery

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- Patients requiring bowel preparation for gastrointestinal or anorectal surgery
Sponsor
VYAS SURGERY
Enrollment
100
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
VYAS SURGERY

Eligibility Criteria

Inclusion Criteria

  • •1\. Male or female patients between 18 and 65 years of age
  • •2\. Posted for any GI surgery or ano\-rectal Surgery and require bowel preparation as per PI discretion (elective procedure)
  • •3\. Patients willing to sign the written informed consent form
  • •Willing and able to understand and comply with all study requirements

Exclusion Criteria

  • •1\. Patients having known hypersensitivity to Na Picosulphate or any of the excipients of product (Tablet Cremalax®)
  • •2\. Pregnant and lactating women
  • •3\. Patients undergoing emergency surgical procedures
  • •4\. Evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit
  • •5\. History of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions
  • •6\. Patients with any cardiac, renal, hepatic, neurological disorders, or any chronic illness
  • •7\. Evidence of cathartic colon or history of laxative abuse
  • •8\. Any systemic condition which would call for avoidance/non\-use of stimulant laxatives
  • •9\. Any other condition, which in the opinion of the clinician/investigator, could interfere significantly with the treatment and assessment process
  • •10\. Use of any investigational therapy within 30 days prior to randomization

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Phase 4
Assessment of Steroneo Skin Cream (Physalis Angulata Supercritical Extract) application for treatment of eczematous lesions
CTRI/2016/11/007511Rehmat Clinic50
Completed
Phase 4
A Clinical trial to study the effects and tolerability of Dacne gel containing Clindamycin Phosphate 1% and zinc acetate in patients suffering from acne.
CTRI/2011/091/000041Glenmark Pharmaceuticals Ltd125
Completed
Phase 4
Assessment of Efficacy, Safety and Tolerability of Fixed Dose Combination Wunder Eye Cream (3% Biophytex LS 8740 an 5% Proteasyl TP LS 8657) in the treatment of under Eye Dark Circles.
CTRI/2011/04/001672Glenmark Pharmaceuticals Limited20
Completed
Phase 4
A clinical trial to study the effect of Hair4U 10% containing (minoxidil 10% plus Aminexil 1.5%)in treatment of male pattern of baldnessHealth Condition 1: null- Androgenetic Alopecia
CTRI/2011/06/001813Glenmark Pharmaceuticals Ltd75
Completed
N/A
Observational Study on cough syrupHealth Condition 1: null- productive cough (cough with expectoration) associated with any of the nasal symptoms (nasal discharge,nasal stuffiness, nasal itching, and Sneezing) since at least previous 8 hours
CTRI/2015/09/006198Dr Reddys laboratories Ltd250