A Prospective open randomized, parallel group clinical study to evaluate the efficacy and safetyof topical treatment in the management of Hemorrhoids in adults.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Other
- Sponsor
- Giellepi Spa
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- 1.Change in the following subjective symptoms: pain, tenesmus, pruritus and anal discharge.
Study Overview
Brief Summary
This clinical study is being planned to assess the efficacy and safety of topical treatment (tube consisting of the cream for topical administration) in subjects with Haemorrhoids with that of subjects who are only on restricted diet. 45 subjects with 1st and 2nd degree haemorrhoids will be included in this study for a period of 14 days. The treatment will check for change in the following subjective symptoms: pain, tenesmus, pruritus and anal discharge as assessed by the subject at day 7 and 14 (categorized as none, mild, moderate and severe). Symptoms will be recorded by each subject daily in a diary distributed at Visit 1. Improvement of pain during defecation (due to lubricant action of the product). Collected by daily questionnaire.Change in overall assessment of disease as assessed by the subject on a 10 cm Visual Analogue Scale (VAS) at day 14; where 0=Best Ever and 10=Worst Ever. Collected by daily questionnaire.Change in the following objective signs: Congestion, oedema, and exudation as assessed by the investigator at day 7 and 14 (categorized as absent or present).
The objective of this study is to evaluate the Efficacy and safety of topical treatment plus restricted diet versus restricted diet alone in subjects with Haemorrhoids.
Type of the study - Prospective open label Randomized controlled for parallel groups.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Subjects willing to give written informed consent.
- •Male or female subjects, between 18 years of age and 70 years age with a diagnosis of haemorrhoids (first or second degree).
- •Except hemorrhoids (first or second degree), the subjects are judged to be in good general health, based on medical history, physical examination.
- •If female of childbearing age, they should be willing to use an acceptable form of birth control measure.
- •They should be stable since last 3 months prior to baseline and throughout the study.
- •Subjects accepting to be on controlled and balanced diet (with exclusion of some foods including hot chili, pepper, chocolate, alcoholic drinks, fried foods).
- •Tea and coffee will be restricted to not more of 2 cups per day.
Exclusion Criteria
- •1.Pregnant and lactating women and women in post-partum period of up to 6 weeks.
- •Subjects with a history of permanent anal prolapse and/or anal fistula
- •Subjects with associated anal fissures and/or infective anal pathology.
- •Subjects with previous history of surgery for anorectal disease (within 5 years) or any other procedures (including but not limited to injection sclerotherapy, rubber band ligation, photocoagulation, cryotherapy etc) within 2 years of enrolment into the trial.
- •Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.
- •Subjects with clinically significant co-morbid condition that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
- •Patients under treatment with other topical therapy for haemorrhoidal syndrome.
- •Subjects participating in any other clinical trial currently or if he/she has completed the trial participation less than 3 months from screening for the current study.
- •Presence of disease states that could affect safety and efficacy evaluation, such as hepatic (e.g., cirrhosis with Child-Pugh Class B or C or MELD score > 9), renal (e.g., requiring dialysis), gastrointestinal (e.g., acute or chronic diverticulitis, irritable bowel syndrome with epigastric pain as a predominant symptom or active inflammatory bowel disease), hematologic, neurologic or brain disorders (e.g., strokes, and brain injury), psychiatric (e.g., bipolar disorder, severe active depression, severe active anxiety), or any other significant condition which, in the opinion of the Investigator, could confound or interfere with evaluation of efficacy, safety, or tolerability of the investigational drug, or prevent compliance with the study protocol.
- •Subjects unwilling to sign the inform consent document.
- •Any condition that in the opinion of the investigator does not justify the subjects inclusion for the study.
- •Known hypersensitivity to, or intolerance of, investigational product or any excipient.
Outcomes
Primary Outcomes
1.Change in the following subjective symptoms: pain, tenesmus, pruritus and anal discharge.
Time Frame: Screening, Day 0,7 and 14.
3.Change in overall assessment of disease as assessed by the subject on a 10 cm Visual Analogue Scale (VAS).
Time Frame: Screening, Day 0,7 and 14.
2.Improvement of pain during defecation
Time Frame: Screening, Day 0,7 and 14.
4.Change in the following objective signs: Congestion, oedema, and exudation
Time Frame: Screening, Day 0,7 and 14.
5.Overall treatment satisfaction questionnaire.
Time Frame: Screening, Day 0,7 and 14.
Secondary Outcomes
- 1.Physical Examination: Examination includes areas such as perianal skin should be assessed.(2.Any reports of adverse or serious adverse events during the treatment period.)