| CTRI Number |
CTRI/2021/06/034497 [Registered on: 30/06/2021] Trial Registered Prospectively |
| Last Modified On: |
29/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A Study on Recurrence of Fistula and inability to control stool Treated by Surgery/Ksharsutra |
|
Scientific Title of Study
|
A Study on Anal Incontinence and Recurrence in Fistula-in-Ano Treated by Surgery/Ksharsutra |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammad Imran |
| Designation |
PG Scholar/junior resident doctor |
| Affiliation |
Institute of Medical Sciences,Banaras Hindu University |
| Address |
A20/80 zergular chauhatta lal khan prahlad ghat, varanasi
Room no.208 sushrut hostel,Trauma centre IMS BHU
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
7880369786 |
| Fax |
|
| Email |
rehaanimran111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Kumar Dwivedi |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences,Banaras Hindu University |
| Address |
Department of Shalya Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Department of Shalya Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9161499774 |
| Fax |
|
| Email |
drarunbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Kumar Dwivedi |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences,Banaras Hindu University |
| Address |
Department of Shalya Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Department of Shalya Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9161499774 |
| Fax |
|
| Email |
drarunbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| FACULTY OF AYURVEDA, IMS BHU VARANASI |
|
|
Primary Sponsor
|
| Name |
DrMohammad Imran |
| Address |
Department of Shalya Tantra Faculty of Ayurveda IMS BHU Varanasi |
| Type of Sponsor |
Other [POST GRADUATION SCHOLAR] |
|
|
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 |
| DrArun Kumar Dwivedi |
Sir Sunderlal Hospital, Institute of Medical Sciences |
DEPARTMENT OF SHALYA TANTRA FACULTY OF AYURVEDA IMS BHU
Varanasi
UTTAR PRADESH |
9161499774
drarunbhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IMS BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: Disease of genitourinary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Observation of patient who have undergone ksharsutra and IFTAK therapy for
complex fistula in ano |
To observe anal incontinence and recurrence of complex fistula in the patient who have gone through ksharsutra and IFTAK therapy |
| Comparator Agent |
Observation of patient who have undergone modern surgeries for complex fistula in ano |
To observe anal incontinence and recurrence of complex fistula in the patient who have gone through modern surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient of complex fistula in ano undergoing surgeries/ksharsutra
Age between 18 to 50 irrespectives to sex
|
|
| ExclusionCriteria |
| Details |
Malignant fistula in ano
Uncontrolled Diabetes
Anemia
Chrons Disease
Ulcerative Colitis
CAcolon
CA Rectum
Ileoceacal Tuberculosis
SRUS(Single Rectal ulcer syndrome)
Non Ambulatory patient
Immunocompromised patient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The incidence of Anal incontinence and Recurrence of Fistula in ano in patient treated with ksharsutra/IFTAK therapy is less as compared to modern surgeries. |
unspecified |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Findind out a better way to treat fistla in ano with minimal risk of complications |
unspecified |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/07/2021 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Topic :A Study on Anal Incontinence and Recurrence of Fistula in ano treated by Surgeries/ksharsutra/IFTAK Plan of study: total 100 patients of fistula in ano will be registered from OPD/IPD of department of shalya tantra and general surgey, SSH,BHU, VARANASI. the study will be carried out in two groups 50 in each group GROUP A : assesment of recurrence and anal incontinence in fistula in ano treated by conventional ksharsutra therapy and IFTAK surgery with the help of manometry and MRI GROUP B: assesment of anal incontinence in fistula in ano treated by modern surgeries of fistula in ano with the help of manometry and MRI. INCLUSION CRITERIA: age between 18 - 50 yrs irrespective of sex. EXCLUSION CRITERIA: patients having malignant fistula in ano, anaemic, tubercular, CA colon. |