Yashtimadhu Ghee Suppository in the management of Fissure in Ano

An Open Labelled Randomized Comparative Clinical Study To Evaluate The Efficacy Of Yastimadhu Ghrita Rectal Suppository And Yastimadhu Ghritapoorana In The Mangement Of Acute Fissure-in- Ano

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084518

Enrollment

300

Registered

2025-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K600- Acute anal fissure

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects exhibiting signs & symptoms of Acute Fissure-in ano below 6 weeks superficial, having well-demarcated edges and confirmed by anorectal examination. 2.Irrespective of gender and aged between 18-60 years. 3.Subjects who are willing to sign the informed consent form

Exclusion criteria

Exclusion criteria: 1.Chronic Fissure in Ano with hypertrophied anal papilla at the proximal aspect of the fissure, a sentinel tag at the distal aspect of the fissure, keratinous edges and/or exposed internal anal sphincter muscle within the base of the fissure. 2.Acute Fissure in Ano secondary to Crohn’s disease, Ulcerative Colitis, Irritable Bowel Syndrome, Tuberculosis of the Intestine, Haemorrhoids, Proctitis, Fistula In Ano and other Ano rectal Disorders. 3.Subjects with anal or perianal malignancy. 4.Female Subjects who are pregnant or lactating. 5.Subjects with Congenital anomalies of rectum and anal canal 6.Subjects with Autoimmune Disease, Anal Suppuration, Anal Abscesses. 7.Subjects with any malignancies or any sexually transmitted diseases 8.Subjects with systemic disease like AIDS, TB, HBV, HCV, Uncontrolled Diabetes Mellitus, Uncontrolled Hypertension, Chronic Liver Disease, Renal Failure 9.Subjects currently participating in another clinical trial for any document or has participated in any clinical trial in the last 90 days.

Design outcomes

Primary

Measure	Time frame
1.To evaluate the efficacy of Yashtimadhu Ghrita Suppository in the management of Acute fissure in ano. 2.To evaluate the efficacy of Yashtimadhu Ghritapoorna in the management of Acute fissure in ano. 3.To compare the clinical efficacy of both Suppositories in the management of Acute fissure in anoTimepoint: 4 weeks	—

Secondary

Measure	Time frame
To standardize the Yashtimadhu Ghrita suppositories by conducting Analytical Study like Stability test.Timepoint: 4 weeks	—

Countries

India

Contacts

Public ContactDrSiddayya Aradhyamath

RGUHS

drsiddesharadhyamath@gmail.com09663591100

Outcome results