Health Condition 1: K600- Acute anal fissure
Conditions
Interventions
Intervention1: Paeonia Officinalis Q: Intervention is planned as administration of Paeonia Officinalis, a homoeopathic medicine orally in mother tincture (Q). Mother tincture will be given 10 drops mi
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects must be 18 years and above with moderate health. 2. Subjects with 4 weeks (28 days) or less history of painful acute anal fissure (AF), prior to screening, where AF-related pain-associated with, or following, defecation is experienced at least twice a week during the symptomatic phase. 3.Subjects with an average of equal or more than of 4 on a 10-point VAS scale during the screening phase for worst anal pain associated with, or following, defecation for the most recent 3 days on which the subject has defecated. 4. Subjects with evidence of a radial fissure; seen on anal examination. 5.Subjects who are not taking any other concomitant oral/topical preparations applied perianally prior to commencing study treatment, and throughout the study. 6. Able to give consent
Exclusion criteria
Exclusion criteria: ? Subjects, who are unwilling to be examined for AF. ? Subjects have undergone a sphincterotomy or anal stretch or other previous interventions involving the anal canal or perianal region ? Subjects having multiple fissures will be excluded. ? Who have had sub-fissure injection of botulinum toxin within 6 months period or used glyceryltrinitrate (GTN) ointment for > 1 week in the 4 weeks prior to the screening visit ? Severely immuno-compromised patients for example patients with history of HIV infection, patients with solid organ transplantation or bone marrow transplantation, patients receiving chemotherapy/radiotherapy, patients with primary immunodeficiency, treatment with oral or intravenous steroids. ? Have cardiovascular disease, fixed anal stenosis/fibrosis or severe haematological illness like Sickle cell disease. ? Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS for PainTimepoint: Baseline, 2, 4, 8 and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation Strain ScoreTimepoint: Baseline, 2, 4, 8 and 12 weeks.;Healing of FissureTimepoint: 4, 8 and 12 weeks;ORIDL scoreTimepoint: 2, 4, 8 and 12 weeks | — |
Countries
India
Contacts
Public ContactAshish Kumar Dixit
All India Institute of Medical Sciences Bhopal
Outcome results
None listed