A clinical trial of a cream to be applied locally for adult subjects with painful growth in the anal region.

Not Applicable

Completed

• Conditions: Health Condition 1: K641- Second degree hemorrhoids

• Registration Number: CTRI/2019/01/017121
• Lead Sponsor: Giellepi Spa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-02-22
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

1.Subjects willing to give written informed consent.

2. Male or female subjects, between 18 years of age and 70 years age with a diagnosis of haemorrhoids (first or

second degree).

3. Except hemorrhoids (first or second degree), the subjects are judged to be in good general health,

based on medical history, physical examination.

4. 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.

5. 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.

2. Subjects with a history of permanent anal prolapse and/or anal fistula

3. Subjects with associated anal fissures and/or infective anal pathology.

4. 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.

5. Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed

consent cannot be obtained.

6. Subjects with clinically significant co-morbid condition that in the opinion of the investigator

could affect the efficacy and safety outcome of the study.

7. Patients under treatment with other topical therapy for haemorrhoidal syndrome.

8. 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.

9. 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.

10. Subjects unwilling to sign the inform consent document.

11. Any condition that in the opinion of the investigator does not justify the subjects inclusion for the

study.

12. Known hypersensitivity to, or intolerance of, investigational product or any excipient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified