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

To Assess the Efficacy and Safety of Cremaffin-Plus® in the Management of Constipation in Patients with Anal Fissure/Fistula/Hemorrhoids/Obstructive Defecation Syndrome (ODS): A Prospective, Non-Comparative Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/10/007403
Enrollment
150
Registered
2016-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Liquid Paraffin 1.25 ml, Milk of magnesia 3.75 ml, Sodium pico sulphate 3.33 mg. : 2 spoon at bed time daily.

Sponsors

V R Medicare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Change in bowel movements and stool consistency (5-point scale)Timepoint: Baseline and 4 weeks

Secondary

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

Countries

India

Contacts

Public ContactDr Roy Patankar

Zen Multispeciality hospital

roypatankar@gmail.com9820075254

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026