Management of Fistula with Apamarga Ksharjala infiltration and Apamarga Kshar sootra

Phase 2

Not yet recruiting

• Conditions: Anal fistula. Ayurveda Condition: Patients,

• Registration Number: CTRI/2022/01/039220
• Lead Sponsor: Institute of teaching and research in Ayurveda Jamnagar Gujarat

Brief Summary

Fistula-in-Ano is a common anorectal condition in the populations worldwide and its prevalence is second highest after haemorrhoids. *Bhagandara* (Fistula-in-Ano) is said callous to be cured and considered under the *Ashta Maharogas* (Eight grave disorders). *Kshara* is one of the chief drug in the preparation of *Kshar*-*sootra* which is gaining worldwide acceptance today. Present study will be carried out to check the efficacy of Apamarga *Ksharjalapooran* in Fistula-in-Ano.

Ø  **Materials and Methods:** In the present study total 30 clinically diagnosed patients having sign and symptoms of *Bhagandara* (*Pidika, Srava, Vedana* and *Kandu* in *Gudapradesha**)* will be divided in two groups by computer generated randomization. One group of the patients will be treated with *Agnikarma* with *Apamarga Ksharjalpooran* and second group of the patients will be treated with *Apamarga Kshar-sootra* application.

Ø **Results and Discussion:** Data generated during the above study will be present in a systemic manner as shall be analyzed and the section where the important points of the Conceptual study, Analytical study, Pharmacological study will be discussed.

Ø **Follow up:** After completion of therapy, follow up will be done for 2 months to assess the status of patient, where patient will be asked to report.

Ø **Side Effects:** These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not aware of. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-04-12
• Study Start: 2022-05-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients having sign and symptoms of Bhagandara like Pidika, Srava, Vedana, Kandu Diagnosed cases of low anal single tract Inter-Sphincteric and Trans-Sphincteric Fistula-in-ano Medically fit for surgery irrespective of sex, caste, religion and occupation.

Exclusion Criteria

Patients below 18 years of age and above 70 years of age Fistula-in-Ano with multiple tracks Fistula-in-Ano associated with Piles and Fissure Crohn’s disease Patient with Diabetes Mellitus : FBS: >140 mg/dl, PPBS: >180mg/dl Patient with Hypertension : Systolic BP:>140mmHg, Diastolic BP: >90 mmHg Cardiovascular disease Pregnancy Malignancy Rectal prolapse Hepatitis B, Tuberculosis, HIV, HCV& VDRL positive cases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To reduce the reccurrence rate of the Fistula-in-ano	upto complete tract healing
To minimize the post operative pain	upto complete tract healing
To minimize the duration of treatment	upto complete tract healing

Secondary Outcome Measures

Name	Time	Method
improve quality of life of person	upto complete tract healing

Trial Locations

Locations (1)

OPD Number 1 and IPD of Shalya Tantra Department ITRA Hospital Jamnagar; 🇮🇳 Jamnagar, GUJARAT, India

OPD Number 1 and IPD of Shalya Tantra Department ITRA Hospital Jamnagar

🇮🇳Jamnagar, GUJARAT, India

Patel Pragati S

Principal investigator

9998243520

pragatispatel0210@gmail.com