Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Benzocaine 206 mg rectal suppository (Kusum Healthcare): The IP will be administered in the morning, at night and after each emptying of the intestine
(preferably after evacuation of bo
Sponsors
Kusum Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age group 18-65 years (both inclusive). 2. Ability to comply with study and follow-up procedures and provide written informed consent. 3. Non smoker Subjects. 4. Subjects’ who able to come for a regular follow up. 5. Subject who will abide by and comply with the study protocol. 6. Subject has not participated in a similar investigation in the past 90 days. 7. Subjects with pain syndrome associated with acute anal fissure or an exacerbation of a chronic anal fissure. 8. Subjects with pain intensity associated with an during or after defecation of > 5 on a 10- point rating scale at the time of the last defecation. 9. Subjects with systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 100 mm Hg. Similarly, diastolic blood pressure with upper limit less than 90 mm Hg and lower limit more than or equal to 70 mmHg. 10. Availability of study Subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 11. If female Subject agrees to abstain from sexual intercourse for the duration of the study will be allowed to participate in the trial. 12. If study Subject is a female and is of child bearing potential practicing an acceptable method of birth controls such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence for the duration of the study as judged by the investigator(s) (Or) She is postmenopausal with spontaneous amenorrhea for at least 01 year Benzocaine 206mg rectal suppository Page 24 of 55 (Or) She is surgically sterile (had a bilateral tubal ligation, bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 06 months).
Exclusion criteria
Exclusion criteria: 1. A known history or present condition of allergic response to investigational drugs or any of its excipients. 2. Any Subject with constipation 3. Reluctance to undergo a visual examination or objective examination of the anal fissure and The presence of more than one (1) anal fissure. 4. Subjects with any underlying uncontrolled medical illness including: a. Diabetes mellitus; b. Hypertension; c. Liver disease or history of alcoholism; d. Renal insufficiency; e. HIV or other immunodeficiency conditions; f. Heart arrhythmias; g. Thyrotoxicosis; h. Thromboembolic disease; i. Granulocytopenia; j. History of any psychiatric disease (including Alzheimer’s disease, Parkinson’s disease), or any other serious medical illness. 5. The need for regular intake of monoamine oxidase inhibitors (MAOs), antidepressants and antihypertensive drugs. 6. Subjects with an anal fissure that is characteristic of other conditions or which led to the occurrence of the latter, in particular, among others: the use of drugs, trauma, HIV infection, anus fistula, inflammatory bowel disease, perianal abscess, or a malignant tumor. 7. Current, recent (in past 90 days prior to screening) or planned participation in an investigational drug study. 8. History of alcohol or drug abuse within 6 months prior to screening 9. Subjects with suspected malignant neoplasms of the rectum 10. Subjects who take antiretroviral therapy 11. Subjects with problems with urination, fecal incontinence, diarrhea and constipation. 12. Subjects are prone to the development of methemoglobinemia. 13. Subjects with known anal sensitivity disorders, rectal infection, known inflammatory bowel disease, anal fistula, diagnosis of rectal cancer. 14. The Subject has taken over the counter medications, including any enzyme modifying drugs (known to induce or inhibit hepatic enzyme activity) or any systemic medication during the study period. 15. Subjects participating in an interventions outside of routine clinical practice; 16. Subjects with Anemia and/or severe/profuse rectal bleeding; Surgery in perianal region in anamnesis; Concomitant treatment with antibiotics/antiseptics, antithrombotics, antineoplastic and/or immunosuppressant; 17. Pregnancy or lactation and positive pregnancy test (above clinical significant limits) in nonmenopausal women. 18. Any Medical, psychological or social condition that may interfere with the subject participation in the study or evaluation of the study results. 19. Any psychological, familial or geographic situation that interferes in the adequate follow-up and adherence to the study protocol. 20. Female Subject who are currently breast feeding and who are likely to become pregnant during the trial will not be allowed to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change of reduction of pain (Visual analog scale)Timepoint: At day 8 compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| To observe the adverse event, i.e. (safety assessment) Other observation: Percentage change of reduction of discharge (using Likert Scale) Percentage change of itching, and discomfort (using Likert Scale) Assessment of quality of life questionnaireTimepoint: At day 8 compared to baseline. | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
IR Innovate Research Pvt. Ltd.
Outcome results
None listed