To Study Effect Of Navakarshika Guggulu With Apamarga Ksharsutra In Bhagandara

Phase 2/3

Not yet recruiting

Conditions: Anal fistula. Ayurveda Condition: BAGANDARAH,

Registration Number: CTRI/2025/05/086913

Lead Sponsor: R A Podar Ayurvedic Medical College ,Worli

Brief Summary: OBJECTIVE:-

PRIMARY OBJECTIVE –

To evaluate the shodhana property of navakarshika guggulu.

SECONDARY OBJECTIVE –

1 To evaluate the ropanaproperty of navakarshika guggulu*.*

2 To evaluate the analgesic propertyof navakarshikaguggulu.

Approximately 39 subjects per group shouldbe recruited for the trial.

Group A Navakarshika guggulu orally for 4weeks along with Apamarga ksharsutra= 39

Group B Apamarga ksharsutra = 39

SELECTION OF PATIENT :-

Selection will bemade on chief complaints of patient, past history, history of associated

disease, inspection,palpation, digital examination, proctoscopy an required criteria as per specially designed Performa fulfilling theinclusion criteria is taken for the study.

ASSESSMENT OF SYMPTOMS :-

Patient will be assess weekly for 8weeks. During each visit UCT will be measure and patient will be questionedregarding the clinical features mentioned in assessment criteria. If fistulatract cut through occur before 8 weeks, then further procedures will be done.

FOLLOW UP:-

Patient will come for weekly follow upfor 8 weeeks.

ASSESSMENT CRITERIA :-

The study will be strictly based onthe assessment of objective parameters and subjective parameters by gradingthem.

The data obtained will be analyzedstatistically.

OBJECTIVE PARAMETER :-

1.      Unit cutting time –

UCTis derived by following formula = Total no. ofdays for cutting

Initial length of track in cm

2.      Srava –

NoDischarge – 0

Mild(if wound wets 1×1 cm gauze piece) in 24 hour – 1

Moderate(if wound wets 1×1 cm 2 gauze piece) in 24 hour – 2

Severe(if wound wets more than 2 gauze piece)in 24 hour -3

SUBJECTIVE PARAMETER :-

1.      Pain – pain measure by VAS Scale

CONCLUSION :- The result will be recordedbefore and after treatment and conclusion will be drawn on the basis ofstatistical analysis.

END POINT:-

1.Cutting rate of fistula track will beenhanced with oral administration of navakarshika guggulu.

2.Comparatively healing of fistulatract will be faster with oral administration of navakarshika guggulu.

3.There will be significant reductionin pain.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 78

Inclusion Criteria

1.Patients with low anal fistula.
2.Irrespective of sex, religion, occupation, economic status and education status.
3.Patients within the age of 20-60yrs.

Exclusion Criteria

1.Patient with high anal fistula.
2.Patients with complex anal fistula.
4.Patient suffering from HIV, HbsAG , any other immunosuppressant Disorders and malignancy will be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cutting rate of fistula track will be enhanced with oral administration of navakarshika guggulu	8 Weeks

Secondary Outcome Measures

Name	Time	Method
Comparatively healing of fistula tract will be faster with oral administration of navakarshika guggulu	8 Weeks
There will be significant reduction in pain	8 Weeks

Trial Locations

Locations (1): M A Podar Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
M A Podar Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Maitri Bhavsar
Principal investigator
9723308290
maitribhavsar18@gmail.com