A Clinical study to evaluate the efficacy of Ayurvedic rectal suppository in the treatment of Anal Fissure.

A Randomized Controlled Clinical study to evaluate the efficacy of Durvadi Tailam Suppository in the management of Anal Pain in Parikartika in Young adults with special reference to Anal Fissure. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058232

Enrollment

220

Registered

2023-10-04

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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.Patients presenting with anal pain and two or more other complaints like bleeding per rectum, painful defecation, constipation and pruritis for a duration of = 6 months. 2.Patients clinically diagnosed of having Acute and Chronic Anal Fissure for a duration of = 6 months presenting with anal pain and two or more other complaints like bleeding per rectum, painful defecation, constipation and pruritis. 3.Patients of either sex will be included. 4.Age 18-60 years old patients included. 5.Patients ready to give informed written consent. 6.Patients ready to abide by the trail procedures meant for this study.

Exclusion criteria

Exclusion criteria: 1.Known cases or suspected cases Irritable Bowel Diseases- Ulcerative diseases and Chron’s diseases. 2.Patients below 18 years and above 60 years of age. 3.Patients with known cases of other Anal conditions like Inflamed or infected Sentinel pile (External tag), Hemorrhoids, Fistula in Ano, Abscess, Proctitis, Malignancy, etc. 4. Patients with following medical conditions requiring stringent medications like o Hematological conditions- Anemia, thrombocytopenia and bleeding disorders. Poorly controlled hypertension ( >160/100 mm Hg) o Uncontrolled diabetes mellitus having hemoglobin A1c (HbA1c) > 8% o With concurrent serious hepatic disorders (defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 times upper normal limit) o With Renal disorders (defined as serum creatinine > 1.2 mg/dL), o With severe pulmonary dysfunction (uncontrolled bronchial asthma and/or chronic obstructive pulmonary disease (COPD)) o Acute and generalized spreading infections o With Immunocompromised status. 5. Patients on medication with corticosteroids, phototherapy, radiotherapy, chemotherapy, biologics, antidepressants, and any other drugs that may have an influence on the outcome of the study. 6. Pregnant females. 7.History of hypersensitivity to any of the trial drugs or their ingredients.

Design outcomes

Primary

Measure	Time frame
To study the Shoolghna ( Analgesic) effect of Durvadi Tailam suppository on Anal pain in Anal Fissure in comparison to Diclofenac Suppository.Timepoint: Duration of treatment 7 days. Follow up on 3rd 5th 7th 15th day	—

Secondary

Measure	Time frame
To assess the Raktasthambak (Haemostatic) effect of the Durvadi Tailam Suppository in Per Rectal Bleeding in Parikartika with special reference Anal Fissure. 2.To assess the Vranaropak (Wound healing) effect of the Durvadi Tailam Suppository in Parikartika with special reference Anal Fissure.Timepoint: Duration of treatment 7 days. Follow up on 3rd 5th 7th 15th day	—

Countries

India

Contacts

Public ContactDr SHATTARKA MAHADIK

APMs Ayurved Mahavidyalaya Sion Mumbai, Maharashtra

sheela.kohad@hotmail.com9920752538

Outcome results