Comparative Study on the Effectiveness of Ashwatha Ointment and Ashwatha Oil in Management Acute Anal Fissures

Phase 2/3

Not yet recruiting

• Conditions: Other specified diseases of the digestive system. Ayurveda Condition: PARIKARTIKA,

• Registration Number: CTRI/2025/06/088427
• Lead Sponsor: Department of Shalyatantra Shree Saptashrungi Ayurved Mahavidyalaya

Brief Summary

OBJECTIVES Primary

• To determine the effect of Ashwatha Ointment on parikartika (Acute Fissue in Ano)

• To determine the effect of Ashwatha Tail in the management on parikartika (Acute

Fissue in Ano)

• To compare effect of Ashwatha Ointment and Ashwatha Tail on parikartika (Acute

fissure in ano)

Secondary

• To study Formulation Procedure of Ashwatha Ointment and Ashwatha Tail as per standard protocol.



PARTICIPANTS:-41 number of patients of each group having age between 18yrs to 70yrs suffering with sign and symptoms of Acute Fissure in Ano  and meeting inclusion and exclusion criteria will be randomised And selected for study from OPD AND IPD department of shalyatantra of Shree Saptashrungi Medical College and Hospital Nashik.

INTERVENTIONS-

41 Patient In group A selected for Ashwatha ointment application

41 Patient in group B selected for Ashwatha oil application



Primary Outcome :

Reduce the sign and symptoms of Acute Fissure in Ano.



Secondary outcome:

Provide long term relief and reduce recurrence.



Treatment Duration : 15 Days



Follow Up :5th , 10th , 15th Days



Data Analysis : Data will be analysed using appropriate statistical methods to compare the

effectiveness of the both intervension group.



Ethical Considerations : The study will be conducted in accordence with ethical guidelines and with

informed consent from participents.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-24
• Last Update Posted: 2025-09-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• 1 Clinically diagnosed cases of Parikartika (Acute fissure in ano) will be taken for the study.
• 2 Patients irrespective of gender, religion, occupation & economic status.
• 3 Patients between the age group of 18 to 70 years.
• 4 Patients which agreed for treatment with informed consent.

Exclusion Criteria

• 1 Age less than 18 years and more than 70 years.
• 2 Patients having Parikartika (Acute Fissure-in-ano) secondary to Ulcerative colitis,Syphilis, Crohn ‘s disease, Tuberculosis and Ca of rectum and anal canal.
• 3 Patients with infectious diseases like HIV/ HbsAg / HCV.
• 4 Patient with uncontrolled Diabetes and Hypertension.
• 5 Patients associated with conditions like Hemorrhoids (Arsha), Fistula-in-ano (Bhagandar).
• 6 Patients with Perianal abscess, rectal prolapsed and severe local sepsis.
• 7 COPD/ Severe Bronchial Asthma.
• 8 Any previous anal surgery.
• 9 Not willing to give consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduce The Sign And Symptoms Of Acute Fissure in Ano	15 days

Secondary Outcome Measures

Name	Time	Method
To provide long term relief and reduce recurrence of Fissure in Ano	10 days

Trial Locations

Locations (1)

Shree Saptashrungi Ayurved Mahavidyalaya And Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Shree Saptashrungi Ayurved Mahavidyalaya And Hospital

🇮🇳Nashik, MAHARASHTRA, India

Dr Anuja Nana Pagar

Principal investigator

09623777474

anujapagar97@gmail.com