Effect of Nyagrodh Tail Pooran in Bhagandara with Special Refernce Fistula in Ano

Phase 2/3

Not yet recruiting

• Conditions: Disease of digestive system, unspecified. Ayurveda Condition: BAGANDARAH,

• Registration Number: CTRI/2025/04/085430
• Lead Sponsor: Khedkar Sonali Jagdish

Brief Summary

After clearance from the Institutional Ethics Commitee Government Ayurveda College and Hospital, Nagpur  Screening of Population will be done from Opd IPd and Casualty of our Institute, 74  patients of  Bhagandara ( Fistula In Ano ) will be included.If Patients fulfil the criteria of Inclusion, Subject would also given freedom to ask their questions all the questions would answer. If he/she agree to participation in study and found fit to include the patient will include in the study.

Study design : Open Labelled Randomized Controlled Trial



Study Setting :The patients attending OPD and IPD of Shalyatantra Department of our institute will be selected as subject for this research  study.



Study Population : Patients attending OPD and IPD of Shalyatantra Department having sign and symptoms of Bhagandara will be selected.



Duration of Study : 18 month after completion of Pre MS



Duration of Treatment : 28days



Sample size



Percentage of effectiveness of Standard Ksharsutra in the management of Bhagandara.....p1=80%



Percentage of effectiveness of Nyagrodh Tail Pooran  in the management of Bhagandara.....p1=81%



alpha error =5%



Power(1-Beta ) = 80%



Required sample size = 34 per Group



Therefore considering 10% dropout /Nonresponse, Final sample size in each group =37



MATCHING CRITERIA



1) Patients having age between 18-70 yrs



2) Patients having clinical signs and symptoms of Bhagandara ( Fistula In Ano)



DIAGNOSTIC CRITERIA



Clinical diagnosis will be done by assessing the presenting signs and symptoms.

1) Pain

2) Discharge through external opening

3) Length of tract in cms



METHODS OF MEASUREMENT -



1) Subjective Criteria -

Pain (Shoola) Visual Scale Analouge Scale for Pain



2) Objective Criteria -

Discharge through external Opening

Length of tract in cm

Healing Time



CLINICAL INVESTIGATIONS -

CBC with ESR

BSL Fasting Postpradial

Urine Routine , Microscopic

HIV

MRI Fistulogram (If necessary)



GROUP A - Standard Ksharsutra Insertion for every 7th day till 28 days



GROUP B - Nyagrodh Tail Pooran  daily for 28 days

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-05
• Last Update Posted: 2025-04-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1.Patient willing to participate in the study 2.patient having age between 18-70 yrs 3.patients will be selected irrespective of sex, marital status, religion, educational status 4.Patients of Bhagandara having single tract low anal fistula 5.patients with tract length upto 6cm 6..co-operative patients.

Exclusion Criteria

1.Patient not willing to participate in the study 2.Patients with high anal fistula with tract length more than 6cm 3.Patients suffering from any major illness (Chrons disease, Ulcerative colitis, Multiple Fistula in ano, carcinoma of Rectum) 4.Immuno-compromised patients 5.Non- cooperative patients 6.Patients having Uncontrolled Dibetes Mellitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To study the effect of Nyagrodh Tail Pooran in the Bhagandara with special reference to Fistula in ano	1st day,7th day,14th day,21th day,28th day
2.To study the effect of ksharasutra in the Bhagandara with special refernce to Fistula in ano	1st day,7th day,14th day,21th day,28th day
3.To compare the effect of Nyagrodh tail Pooran And Ksharsutra in the Bhagandara with special refernce to Fistula in ano	1st day,7th day,14th day,21th day,28th day

Secondary Outcome Measures

Name	Time	Method
1.To study the effect of Nyagrodh Tail Pooran in unit Healing time	2.To study the literature regarding drug and disease through ayurvdic text and Morden Medicine Science

Trial Locations

Locations (1)

Government Ayurveda College and Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Government Ayurveda College and Hospital

🇮🇳Nagpur, MAHARASHTRA, India

Dr Khedkar Sonali Jagdish

Principal investigator

9834564082

sonalikhedkar33@gmail.com