An Open Randomized Controlled Clinical Study To Evaluate The Add On Effect Of Oral Administration Of Navakarshika Guggulu Along With Apamarga Ksharsutra In The Management Of Bhagandara W.S.R To Low Anal Fistula.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Cutting rate of fistula track will be enhanced with oral administration of navakarshika guggulu
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
Cutting rate of fistula track will be enhanced with oral administration of navakarshika guggulu
Time Frame: 8 Weeks
Secondary Outcomes
- 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)