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Clinical Trials/CTRI/2022/01/039220
CTRI/2022/01/039220Not yet recruitingPhase 2

Efficacy of Agnikarma with Apamarga Ksharjalpoorana and Apamarga Ksharsootra application in the management of Bhagandara(Fistula-in-ano)- An open labelled Randomized comparative clinical trail

Institute of teaching and research in Ayurveda Jamnagar Gujarat1 site in 1 country30 target enrollmentStarted: May 2, 2022Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
To reduce the reccurrence rate of the Fistula-in-ano

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

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.

Outcomes

Primary Outcomes

To reduce the reccurrence rate of the Fistula-in-ano

Time Frame: upto complete tract healing

To minimize the post operative pain

Time Frame: upto complete tract healing

To minimize the duration of treatment

Time Frame: upto complete tract healing

Secondary Outcomes

  • improve quality of life of person(upto complete tract healing)

Investigators

Sponsor
Institute of teaching and research in Ayurveda Jamnagar Gujarat
Sponsor Class
Research institution and hospital

Study Sites (1)

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