Health Condition 1: K602- Anal fissure, unspecified
Conditions
Interventions
Intervention1: Arshkeyt- Kit: 1. Arshkeyt Tablets: 2 tablets thrice a day with
sufficient water.
2. Arshkeyt Cream: To be applied at least twice a day
and after each act of defecation.
3. Arshkeyt Pow
Sponsors
Solumiks Herbaceuticals Limited
Superintendent
Eligibility
Inclusion criteria
Inclusion criteria: 2.Patients with a confirmed diagnosis of anal fissure. 3.Patients with previous history of no treatment or only conservative treatment, consisting of sitz bath and/or Isabgol powder and/or high fibre diet in the last 1 month. 4. Patients with a composite score of > 4 at baseline visit.
Exclusion criteria
Exclusion criteria: 1. Patients having anal fistulas or anal fissure of various causes such as Crohn’s disease, anal suppuration, abscesses (Secondary underlying causes). 2. Patients having anal or perianal malignancy. 3. Patients with diagnosis of any illness (other than anal fissure) with presentation of per-anal bleeding 4. Patients with history of > 3 recurrences of anal fissure post medical or surgical intervention. 5. Patients on oral calcium channel blockers or vasodilators like minoxidil, hydralazine or alprostadil. 6. Patients who have a history of topical therapy with nitroglycerine/ lignocaine/ steroids/ calcium channel blockers in the past one month. 7. Patients who are pregnant or lactating. 8. Patients with history of life threatening cardiovascular and /or neurological event in the past one year. 9. Patients with auto-immune disease, uncontrolled hypertension, uncontrolled diabetes mellitus(requiring change in antidiabetic therapy every 3 months) and chronic severe respiratory disease. 10. Patients with documented evidence of renal function tests > 1 and a half times of normal reference range at baseline visit. 11. Patients withdocumented evidence of liver function tests > 2 and a half times of normal reference range at baseline visit. 12. Patients with history of HIV/HBV/HCV infection in the past. 13. Patients on herbaceutical medication since the last 3 months. 14. Patient allergic to any of the ingredients of trial drug or the comparator drug. 15. Patients currently participating in another clinical trial for any indication or has participated in any clinical trial in the last 30 days. 16. Patient not willing to sign on the informed consent document or not willing to come for follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing of Anal FissureTimepoint: 6 Week | — |
Secondary
| Measure | Time frame |
|---|---|
| Relive from Constipation and Hard stoolTimepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactDr Vivekanand Kullolli
Parul Institute of Ayurved
Outcome results
None listed