A clinical trial to compare manually made kshar sutra with kshar sutra prepared by automated machine in patients having Fistula in Ano.
Not Applicable
- Conditions
- Health Condition 1: K928- Other specified diseases of the digestive system
- Registration Number
- CTRI/2021/12/038414
- Lead Sponsor
- CCRAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients of either sex aged 18-60 years.
2.Confirmed case of fistula in ano.
3.Presence of any of the associated symptoms like Discharge, Pain, Tenderness, Itching, Induration / Swelling.
4.Willing and able to participate till the trial completes
Exclusion Criteria
1.Patients aged <18 and >60 years.
2.Fistula connected with other organs like urethra, vagina etc.
3.Patients with malignancy
4.Tuberculosis/ uncontrolled Diabetes/ established Systemic diseases like Ulcerative colitis, Crohnââ?¬•s disease etc.
5.Bleeding diathesis.
6.Patients who have completed participation in any other clinical trial during the past six (06) months.
7.Any other condition which the Investigator thinks may jeopardize the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the Quality of Life (SF-36 Health Survey) ScoreTimepoint: At baseline, And after final thread cut out
- Secondary Outcome Measures
Name Time Method Fistula cutting time through kshara sutra <br/ ><br>Validation of the ksharasutra prepared by the automated machine and establishment of the usefulness of the automated ksharasutra machine in comparision to the standard Ksharasutra manually prepared <br/ ><br>Timepoint: At baseline, and after final thread cut out