Efficacy and Safety study of Cremalax-plus for treatment of Piles, Anal Fissure/Fistula and constipatio

Not Applicable

Conditions: Health Condition 1: null- OPD Patients with constipation associated with Anal fissure,fistula,hemorrhoids and obstructive defecation syndrome.

Registration Number: CTRI/2016/10/007403

Lead Sponsor: V R Medicare Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

1)Adult male or female patients .

2)Age between 18 and 65 years.

3)Suffering from constipation secondary to anal fissures, or anal fistula, or hemorrhoids (piles), or obstructed defecation syndrome (ODS).

4)Patients willing to sign written authorization (informed consent) to provide their data for the study

5)Willing and able to understand and comply with all study requirements.

Exclusion Criteria

1)Primary idiopathic constipation.

2)History of organic disease of the colon, ileus, any acute surgical abdominal conditions.

3)Presence of active gastrointestinal disease, obstruction or dehydration, as well as ingestion of any drug affecting gastrointestinal motility or known hypersensitivity study compounds were also excluding factors.

4)Patients that would require adrenocorticosteroids or cardiac glycosides treatments as per the investigators discretion.

5)Patients having severe cardiac, hepatic, neurological and renal diseases.

6)Pregnant or lactating women.

7)Use of any investigational therapy within 30 days prior to randomization.

8)Patients not willing to provide written informed consent.

9)Any other condition, which in the opinion of the clinician/investigator, could interfere significantly with the treatment and assessment process.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in bowel movements and stool consistency (5-point scale)Timepoint: Baseline and 4 weeks

Secondary Outcome Measures

Name	Time	Method
Change in straining during defecation. <br/ ><br>Physiciansâ?? global efficacy assessment for severity of constipation on the basis of the frequency and consistency of stools. <br/ ><br>Constipation Scoring System (CSS). <br/ ><br>Patient Assessment of Constipation â?? Symptom (PAC-SYM). <br/ ><br>PACâ??QoL (Quality of life). <br/ ><br>Modified Longo Score (MODS) for ODS.Timepoint: Baseline and 4 weeks