MedPath

Homoeopathic treatment of tear in anal canal

Phase 2
Conditions
Health Condition 1: K601- Chronic anal fissure
Registration Number
CTRI/2023/03/050632
Lead Sponsor
D N De Homoeopathic Medical College and Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Cases suffering from chronic anal fissure ICD-10(K60.1), with symptoms persisting for more than 6 weeks.

2. Participants of either sex or transgender.

3. Age between 18 and 65 years.

4. Literate patient; ability to read and write in Bengali and/or English. Illiterate participants will be interviewed by the investigators maintaining adequate privacy to fill up the scale or questionnaires

5. Patients with known but controlled systemic diseases.

6. Patients using topical agents for anal fissure will be included after a washout period of one week, subject to persistence of symptoms and signs of fissures.

7. Patients giving written consent voluntarily to participate.

Exclusion Criteria

1.Cases suffering from uncontrolled systemic illness or life-threatening infections.

2. Cases already undergoing homoeopathic treatment elsewhere for any chronic purpose within last 6 months.

3. Patients with the habit of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.

4. Previous history of surgical interventions for anal fissure.

5. Diagnosed or suspected cases of rectal malignancies.

6. Pregnancy, puerperium and lactation.

7. Patients with psychiatric diseases.

8. Secondary fissure.

9. Vulnerable population- Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.

10. Simultaneous participation of any other clinical trial

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The scoring system for anal fissure (REALISE)Timepoint: At baseline, every 15 days, up to 3 months
Secondary Outcome Measures
NameTimeMethod
Anorectal symptom severity and quality of life questionnaire (ARSSQoL) <br/ ><br>Measure yourself medical outcome proile (MYMOP-2) <br/ ><br>Timepoint: Every month, every 15 days, up to 3 months
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