| CTRI Number |
CTRI/2024/05/068046 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to treat Bhagandar (fistula-in-ano) with modified technique of ksharasutra that will reduce time duration and will give better cosmetic result |
|
Scientific Title of Study
|
Evaluation of the outcome of modified conventional Ksharasutra therapy(MC-KST) for the management of Bhagandar(fistula-in-ano)- A prospective study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himanshu Rathore |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda,Gautampuri, Sarita Vihar New Delhi |
| Address |
Department of Shalya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
8178164724 |
| Fax |
|
| Email |
himanshu997rathore@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vyas Deva Mahanta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi |
| Address |
Department of Shalya Tantra All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
7838957972 |
| Fax |
|
| Email |
Drvyasayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Yogesh Badwe |
| Designation |
Professor and HOD |
| Affiliation |
All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi |
| Address |
Department of Shalya Tantra All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
9011060498 |
| Fax |
|
| Email |
dryogesh.badwe@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda Gautampuri New delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Gautampuri Sarita Vihar New Delhi-110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Himanshu Rathore |
All India institute of Ayurveda, surgery OPD 104/105 |
Gautampuri Sarita Vihar New Delhi-110076
South
DELHI |
8178164724
himanshu997rathore@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 | - | Cedanakarma, छेदनकरà¥à¤® | (Procedure Reference: Sushruta Chikitsa sthan adhyay 8, Procedure details: This procedure will be done under Spinal/local anesthesia. First identification of the fistulous track with the help of probe then a small incision will be given at inter-sphincteric space or near the external sphincter and intercept the fistulous track under direct vision and apply the Apamarga Ksharsutra between created window and internal opening followed by Coring out the remaining fistulous track from external opening. The total duration will be 6 weeks and 6 time ksharsutra will be changed. rest follow up will be done every month.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Trans-sphincteric Fistula in Ano /
Riju Bhagandara
Controlled HTN & DM
|
|
| ExclusionCriteria |
| Details |
1.Unfit for surgery
2.Fistula in ano secondary to other diseases
3.Tuberculosis, Uncontrolled HTN and DM.
4.Crohn’s/ Ulcerative colitis
5.CA Rectum and CA Colon.
6.VDRL, HIV and HBsAg positive patients.
7.Osteomyelitis (Pelvic bones and coccyx)
8.Bleeding disorders
OTHER CONDITIONS
9.Pregnancy.
10.High anal fistula
11.Patient who are not willing to be part of study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Healing of Bhagandara (fistula in Ano) w.r.t. Faster Recovery(in Days) ,Pain, Recurrence(FRPR).
|
treament for 6 weeks followed by follow-up at every month for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
10/06/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a prospective study to appraise the efficacy of a modified surgical technique that is Modified conventional Ksharsutra therapy (MC-KST) technique w.r.t FRPR (Faster recovery, Pain, Recurrence) for the management of Bhagandar/Fistula in ano In 30 patients of age 20 to 60 years considering the riju bhagandar/trans-sphincteric Fistula and Controlled HTN & DM. Study will be conducted at AIIA with duration of 6 week of treatment with follow up at every month for 6 months,the Primary outcome will be Healing of the fistulous tract, pain and recurrence. The standard treatment will be given in the study duration. Hypothesis-MC-KST is an effective surgical technique for the management of Bhagandara (Fistula- in-Ano) w.r.t. Faster Recovery, Pain, Recurrence (FRPR). |