| CTRI Number |
CTRI/2019/06/019915 [Registered on: 27/06/2019] Trial Registered Prospectively |
| Last Modified On: |
27/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two different methods of surgery, Ksharsutra ligation and Fibrin Glue application for the patients with Fistula in ano. |
|
Scientific Title of Study
|
Integrative Approach Of Management Of Fistula-In-Ano With Ksharsutra Followed By Fibrin Glue-A Randomised Controlled Clinical Trial |
| Trial Acronym |
FIAKSFG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Nilkantha Shinde |
| Designation |
PhD Scholor |
| Affiliation |
Government Ayurved College and Hospital, Nagpur |
| Address |
Dept. of Shalyatantra, Govt. Ayurved Collegeand Hospital, Nagour, Pin 440024
Maharashtra, India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9975830051 |
| Fax |
|
| Email |
drjyoti.dalal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raut S Y |
| Designation |
Guide and HOD, Shalyatantra Department. |
| Affiliation |
Government Ayurved College and Hospital, Nagpur |
| Address |
Dept. of Shalyatantra, Govt. Ayurved College and Hospital, Sakkardara Chowk,Nagour, Pin 440024
Maharashtra, India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9975830051 |
| Fax |
|
| Email |
drsyraut@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raut S Y |
| Designation |
Guide and HOD, Shalyatantra Department. |
| Affiliation |
Government Ayurved College and Hospital, Nagpur |
| Address |
Dept. of Shalyatantra, Govt. Ayurved College and Hospital, Nagpur, Pin 440024
Maharashtra, India
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9975830051 |
| Fax |
|
| Email |
drsyraut@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Jyoti N. Shinde (self), Dept. of Shalyatantra,Govt. Ayurved College and Hospital,Sakkardara Chowk, Nagpur,Maharashtra.440024 |
|
|
Primary Sponsor
|
| Name |
Jyoti Shinde |
| Address |
Department of Shalyatantra,Government Ayurved College and Hospital, Nagpur |
| Type of Sponsor |
Other [selg] |
|
|
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 |
| Jyoti Shinde |
Government Ayurved College and Hospital, Nagpur |
Room No 3, Shalyatantra OPD, Hospital Division,Sakkardara Chowk, Nagpur
Govt. Ayurved College,
Raje Raghuji Nagar, Sakkardara Square,Nagpur.
Nagpur
MAHARASHTRA |
9975830051
drjyoti.dalal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Ayurved College and Hospital, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fibrin Glue |
Fibrin Glue 0.5 ml to 1 ml as per requirment, using single dose to seal the fistulous tract. If the tract failed to heal in first attempt, second or third dose of Fibrin glue ( 0.5 ml / 1 ml) will be applied as per need to close the tract.
Under all aseptic precautions and suitable anaesthesia, Ksharsutra will be inserted in fistulous tract from external to internal opening in anal canal and two ends of the ksharsutra will be tied forming a loop.Ksharsutra will be changed after the interval of every 5 days by rail-road technique till the debridment of tract.After debridment, when the fistulous tract becomes clean and healthy. It requires 3 to 5 weeks to achieve the debridment and cleaning of the tract .Then the tract will be sealed by applying Fibrin Glue. Proper analgesic drugs will be given as per need. |
| Comparator Agent |
Ksharsutra |
A single Ksharsutra of length 1 feet, used once on every 5th day, upto the complete healing of fistulous tract.
underall aseptic precautions and under the suitable anaesthesia with patient in lithotomy position, Ksharsutra will be inserted into the fistula tract with the help of Fistula Probe through the external opening, gradually extended to the internal opening, taken out of the anal canal and two ends of the Ksharsutra will be tied forming a loop.
Change of Ksharsutra will be done after the interval of every 5 days by rail-road technique.
Proper analgesic drug will be given as per the need.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Selection of patients will be done irrespective of sex, religeon,ocupation, economic status and education status.
2.The selected patient should have diagnosed as Bhagandara ( Fistula-in-ano ).
3.Singal tract with no ramifications, low anal with tract length upto 5 cm to 7 cm.
|
|
| ExclusionCriteria |
| Details |
1.Patient suffering from systemic disorders like Tuberculosis, Diabetes Mellitus , Cancer and Immuno-compromised patients.
2.Patient with high anal fistula and more than 7 cm tract length.
3.Patient suffering from carcinoma of rectum, Hb’SAg and HIV
4.Patient suffering from ulcerative colitis, crohn’s disease and multiple fistula will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on ie. On every 5 days interval till complete cutting and healing of the fistula tractby Ksharsutra. |
The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on ie. On every 5 days interval till complete cutting and healing of the fistula tractby Ksharsutra. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The subject will be observed for the rate and duration of closure of fistula tract until the tract is completely and permanently closed by Fibrin Glue.. |
The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on ie. On every 5 days interval till complete healing of the fistula tract by Fibrin Glue.. |
The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on upto the complete debridment (i. e till the stage of Shuddhavastha is acheved).
After debridment, the fistulous tract will be sealed with Fibrin Glue.There after,the subject will be observed for the rate and duration of closure of fistula tract until the tract is completely and permanently closed.
|
The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on ie. On every 5 days interval till complete cutting and healing of the fistula tractby Ksharsutra followed by Fibrin Glue. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/07/2019 |
| Date of Study Completion (India) |
19/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
3 RESEARCH PAPERS RELATED TO THE TOPIC ARE PUBLISHED IN INTERNATONAL PEER REVIEWED INDEX JOURNALS.
4th research paper entitled Effect of local application of Utsadaniya lepa in the management of deep wound- a single case study" is submitted to journal "AYU" on 31st October 2022 for publication with manuscript no. "ayu_274_22" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a Randomized Controlled Clinical Trial on Integrated approach to the management of low anal fistula with Ksharsutra followed by Cyanoacrylate Glue sealing.In this study Fibrin glue is replaced with the CYNOACRYLATE GLUE. because Fibrin glue was not easily available, there is a high risk of allergic reaction and the cost is too high.On the other hand Cynoacrylate giue is easily available ,has no allergic reaction and cost effective. Main purpose behind this trial is to explore the basic principal of ’healing of wound in Shuddhavastha". Bhagandat is a chronic and continuously infected tract lined by unhealthy granulation and fibrous tissue.. It is observed in various scientific studies that.all the surgical treatment options for the fistula in ano are carried out in the "Dushtavastha" ie. infected stage of fistula. Sushruta was well aware about wounds and its management. He strongly quoted that there will be delayed or non healing of the wound unless Shuddhavastha of the wound is achieved.
In the present study. total 90 patients were assigned randomly to 3 groups. Patients in group A received Cyanoacrylate glue followed by Ksharsutra therapy. Patients in Group B received Ksharsutra therapy, while patients in group C received Cyanoacrylate glue sealing. All the patients were observed weekly i.e. on 1st, 7th, 14th, 21st day and so on till the complete healing of fistula tract. Effect of the therapy was assessed on the on the basis of relief in subjective as well as objective criteria. Patients were followed up to 6 months after completion of treatment. The observed results were assessed statistically to drive the final outcome.. It was observed that all the therapies were effective in reducing pain, discharge, inflammation and tenderness. Though ksharsutra therapy is 100 % effective in terms of curing the fistula in ano, it took longer duration of time. Also persistent pain and discomfort was observed by the patients during treatment period. But the rate of recurrence was negligible by Ksharsutra therapy. On the other hand, experimetal group A showed less duration of treatment, early recovery, minimal operative time and hospital stay, pain was comparitively less than other 2 groups. But it was observed that, recurrence was more in group A , as compared to group B., butbit was less than gtoup C. From this, we can say that, the surgical techniques are adopted in dushtavastha of fistula vrana., which might be the case of recurrence .Finally we can conclude that, ksharssutra ligation until shuddhavastha of vrana, followed by cyanoacrylate glue sealing in comparison to standard ksharsutra therapy can be better ulternative to curtail the prolonged duration of treatment. |