| CTRI Number |
CTRI/2024/04/065703 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two surgical techniques namely IFTAK and partial fistulectomy with applicaion of ksharasutra for management of fistula in ano |
|
Scientific Title of Study
|
A Comparative Study Between Partial Fistulectomy with Ksharasutra Application and Interception of Fistula Track with Application of Ksharasutra (IFTAK) to Evaluate their Effect in the Management of Bhagandara w.s.r. to Complex Fistula-In-Ano |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Kulwant Singh Himaliyan |
| Designation |
Professor |
| Affiliation |
R.G.G.P.G. Ayurvedic College and Hospital Paprola, Kangra |
| Address |
Room No. 208, Department of Shalya Tantra, Anatomy Block R. G.G.P.G Ayurvedic college and hospital Paprola Kangra OPD No. 105, Department of Shalya Tantra, RAH Paprola, Baijnath Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418251550 |
| Fax |
01894242064 |
| Email |
drkulwanthimaliyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Kulwant Singh Himaliyan |
| Designation |
Professor |
| Affiliation |
R.G.G.P.G. Ayurvedic College and Hospital Paprola, Kangra |
| Address |
Room No. 208, Department of Shalya Tantra, Anatomy Block R. G.G.P.G Ayurvedic college and hospital Paprola Kangra OPD No. 105, Department of Shalya Tantra, RAH Paprola, Baijnath Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418251550 |
| Fax |
01894242064 |
| Email |
drkulwanthimaliyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupendra Kumar Rathore |
| Designation |
PG Scholar Shalya Tantra Department |
| Affiliation |
R.G.G.P.G. Ayurvedic College and Hospital Paprola, Kangra |
| Address |
Room No.105 Department of Shalya Tantra R.G.G.P.G. Ayurvedic College and Hospital Paprola, Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8003879366 |
| Fax |
|
| Email |
bhupendrakumarrathore.55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak pharmacy, R.G.G.P.G. Ayurvedic College Paprola kangra, Himachal pradesh
Pin Code 176115 |
|
|
Primary Sponsor
|
| Name |
Principal R.G.G.P.G. Ayurvedic college and hospital Paprola |
| Address |
R.G.G.P.G. Ayurvedic College and Hospital Paprola |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Kulwant Singh Hiamliyan |
R. G. G. P. G. Ayurvedic College and Hospital Paprola |
Room No. 209 Department of Shalya Tantra, Anatomy Block R.G.G.P.G. Ayurvedic College and Hospital Paprola Kangra
Kangra
HIMACHAL PRADESH |
9418251550
01894242064
drkulwanthimaliyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee human Rajiv Gandhi Govt. Post Garduation Ayurvedic College And Hospital Paprola Himachal Pradesh Pincode 176115 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K605||Anorectal fistula. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: , Procedure details: During the procedure of IFTAK fistula track will be intercept at the inters sphincteric space. Ksharasutra will be applied in the proximal track )
| | 2 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: , Procedure details: During the procedure of ‘Partial fistulectomy with Ksharasutra application’ partial fistulectomy is done by just excising the total track along with the probe without interfering the sphincter bundle and Ksharasutra was applied to the sphincter bundle.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All type of complex fistula may be fresh/recurrent, had multiple tracks as well as horseshoe fistula.
Patients who have given informed & written consent to participate in the trial.
Patients between age group 20-60 years of age of either gender. |
|
| ExclusionCriteria |
| Details |
a)Non cryptoglandular origin fistula-in-ano.
b)Extrasphincteric, supralevator and translevator fistula.
c)Patients below age of 20 yrs and above 60 yrs of age.
d)Bleeding disorders.
e)Existing continence disturbance.
f)Uncontrolled diabetes mellitus & hypertension.
g)Patient with malignancy, tuberculosis, COPD .
h)ICTC, HBsAg positive case.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The present study aims to evaluate the outcome of both techniques Partial fistulectomy with K
ksharasutra application and interception of fistula track with application of ksharasutra (IFTAK) in the management of bhagandara w.s.r. to complex fistula-in-ano†|
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the best surgical technique for management of bhagandara among two techniques. |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study
efficacy of an advanced, innovative & emerging, minimal invasive Ksharasutra technique named IFTAK
(Interception of Fistula Tract with application of Ksharasutra) will be compared & evaluated with most commonly
used “Partial fistulectomy with Ksharasutra application†for knowing that
which technique having more potency in better management of complex fistula in
ano along with needful issues eg. post operative pain, anal function, duration
of treatment and scar mark. |