| CTRI Number |
CTRI/2019/01/016836 [Registered on: 01/01/2019] Trial Registered Prospectively |
| Last Modified On: |
31/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clincal Study To Evaluate The Efficacy Of Karaveera Kshara Sutra(Alkali Thread) And Chitraka Kshara Sutra(Alkali Thread) In The Management Of Bhagandara W S R To Fistula In Ano |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Karaveera Kshara Sutra And Chitraka Kshara Sutra In The Management Of Bhagandara W S R To Fistula In Ano |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhuri G Hegde |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre |
| Address |
Department Of Shalyatantra, Room No 22, Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre No 10 Pipeline Road R P C Layout Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9448236757 |
| Fax |
|
| Email |
hegdemadhuri22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailaja S V |
| Designation |
Prof and Head |
| Affiliation |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre |
| Address |
Department Of Shalyatantra, Room No 22, Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre No 10 Pipeline Road R P C Layout Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9880917253 |
| Fax |
|
| Email |
shailajaramkumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhuri G Hegde |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre |
| Address |
Department Of Shalyatantra, Room No 22, Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre No 10 Pipeline Road R P C Layout Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9880917253 |
| Fax |
|
| Email |
hegdemadhuri22@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Madhuri G Hegde |
| Address |
Department Of Shalyatantra, Room No 22, Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre No 10 Pipeline Road R P C Layout Vijayanagar Bengaluru 560104 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Dr Shailaja S V |
, Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre |
Department Of Shalyatantra, Room No 22, Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre No 10 Pipeline Road R P C Layout Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA |
9880917253
shailajaramkumar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCH AND RC BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K605||Anorectal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chitraka Kshara Sutra
|
Patients treated with chitraka kshara sutra and subsequent change till complete excision of tract
Ushnajala avagaha sweda for 20mins once daily after defaecation
Triphala guggulu 500mg 2bd for 4 weeks
|
| Intervention |
Karaveera Kshara Sutra |
Patients treated with karaveera kshara sutra and subsequent change till complete excision of tract
Ushnajala avagaha sweda for 20mins once daily after defaecation
Triphala guggulu 500mg 2bd for 4 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients With Bhagandara (Fistula In Ano) Suitable For Kshara Sutra Karma.
Patients With Bhagandara (Fistula In Ano) Aged Between 18-70 Years Irrespective Of Sex, Caste And Religion Will Be Selected.
|
|
| ExclusionCriteria |
| Details |
Patients Having Bhagandara (Fistula In Ano) With Any Systemic Disease Interfering With The Course Of Treatment.
Patients Having Bhagandara (Fistula In Ano) With More Than 2 Opening In Perianal Region.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy Of Intervention Over Subjective And Objective Criteria Of Bhagandara W S R To Fistula-In-Ano |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
02/01/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Bhagandara Is One Among The Mahagadas And Represents Fistula-In-Ano With An Overall Incidence
Of 9 Cases Per 1,00,000 Population Per Year. Kshara Sutra Ligation As Mentioned In Nadivrana Chikitsa Is The Choice Of Management In Bhagandara. This Study Is Simple
Randomised Comparative Clinical Study To Evaluate The Efficacy Of Karaveera Kshara Sutra And Chitraka Kshara Sutra With Subsequent
Change Of Kshara Sutra Till Complete
Excision Of Tract Along With Ushna Jala
Avagaha Sweda And Triphala Guggulu
500mg 2 Bd As Adjuvants. It Will Be Conducted With 20 Patients In Each Group Of
Bhagandara (Fistula-In-Ano) In Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Centre |