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
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)