| CTRI Number |
CTRI/2024/09/073216 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| 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 Study To Test The Effectiveness Of Nimba Ksharsutra in The Treatment Of Fistula-in-Ano. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study To Evaluate The Efficacy Of Nimba Ksharsutra In The Management Of Bhagandar (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 |
Dr Ganesh Uttamrao Asole |
| Designation |
PG Scholar Shalyatantra Department |
| Affiliation |
CSMSS Ayurved College kanchanwadi, Chhatrapati Sambhajingar Department of Shalyatantra opd no-16 |
| Address |
Chhatrapati Shahu Maharaj Sanstha Ayurved Mahavidyalaya & Rugnalaya Kanchanwadi,Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7977488018 |
| Fax |
|
| Email |
gaganesh99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Babasaheb Nana Gadve |
| Designation |
Professor and HOD of Shalyatantra Department |
| Affiliation |
CSMSS Ayurved College kanchanwadi, Chhatrapati Sambhajingar |
| Address |
Chhatrapati Shahu Maharaj Sanstha Ayurved Mahavidyalaya & Rugnalaya Kanchanwadi,Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9822682898 |
| Fax |
|
| Email |
drgadvekayakalp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Uttamrao Asole |
| Designation |
PG Scholar Shalyatantra Department |
| Affiliation |
CSMSS Ayurved College kanchanwadi, Chhatrapati Sambhajingar |
| Address |
Department of Shalyatantra
opd no-16
Chhatrapati Shahu Maharaj Sanstha Ayurved Mahavidyalaya & Rugnalaya Kanchanwadi,Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7977488018 |
| Fax |
|
| Email |
gaganesh99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar
Maharshtra
India
431011 |
|
|
Primary Sponsor
|
| Name |
C.S.M.S.S. Ayurved College Kanchanwadi Chhatrapati Sambhajinagar |
| Address |
Department of Shalyatantra C.S.M.S.S.Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar. |
| Type of Sponsor |
Private 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 |
| DrGanesh Uttamrao Asole |
C.S.M.S.S Ayurved Mahavidyalaya & Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar |
OPD No.16 Of Shalyatantra Department C.S.M.S.S Ayurved Mahavidyalaya & Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar 431011
Aurangabad
MAHARASHTRA |
7977488018
gaganesh99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS Ayurved College and Hospital Kanchanwadi,Chhatrapati Sambhajinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. 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: Rastarangini 24/527-530, Procedure details: 1. First the patient will be taken on the table and give a lithotomy position.
2. Cleaning and draping of the perianal region with all aseptic precautions will be done, and we will cover the local area with a towel.
3. Local anaesthesia will be given.
4. Later gloved finger of right hand of the surgeon will be gently introduced into the rectum.
5. A slit proctoscope will be inserted gently to visualise the internal opening clearly.
6. Then a suitable selected probe will be passed through the external opening of fistula. Then the tip of the probe was forwarded along the path of least resistance and will be guided by the finger in rectum to reach into the lumen of anal canal through the internal opening and its tip will be finally directed to come out of anal orifice.
7. Then a suitable length of Nimba KsharaSutra According to the will be taken and threaded into the eye of probe. and then the probe will be withdrawn, leaving behind thread throughout the entire fistulous track.
8. The Two ends of thread will be tied outside the anal canal.)
(1) Medicine Name: Nimbaksharsutra, Reference: sushrut sutrasthan 11/11, Route: Rectal, Dosage Form: Kshara, Dose: 8(NA), Frequency: sos, Duration: 8 Weeks | | 2 | Comparator Arm | Procedure | - | ksharsutra | (Procedure Reference: Rastarangini 24/527-530, Procedure details: 1. First the patient will be taken on the table and give a lithotomy position.
2. Cleaning and draping of the perianal region with all aseptic precautions will be done, and we will cover the local area with a towel.
3. Local anaesthesia will be given.
4. Later gloved finger of right hand of the surgeon will be gently introduced into the rectum.
5. A slit proctoscope will be inserted gently to visualise the internal opening clearly.
6. Then a suitable selected probe will be passed through the external opening of fistula. Then the tip of the probe was forwarded along the path of least resistance and will be guided by the finger in rectum to reach into the lumen of anal canal through the internal opening and its tip will be finally directed to come out of anal orifice.
7. Then a suitable length of Nimba KsharaSutra According to the will be taken and threaded into the eye of probe. and then the probe will be withdrawn, leaving behind thread throughout the entire fistulous track.
8. The Two ends of thread will be tied outside the anal canal.)
(1) Medicine Name: Apamargksharsutra, Reference: sushrut sutrasthan 11/11, Route: Rectal, Dosage Form: Kshara, Dose: 8(NA), Frequency: sos, Duration: 8 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The Patient Age Group is 20-70 yr
Patient Having low Anal Fistula in Ano
Fistula In Ano Having Length less than equal to 4cm (including 4cm track)
|
|
| ExclusionCriteria |
| Details |
Patient Having High Anal fistula in Ano
K/c/o - Cancer of Rectum
H/o Prolapsed Rectum
Pregnant Women,AIDS,Hepatitis,TB Positive
Patient Suffering From Uncontrolled DM,HTN |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Veadana ,Daha , Kandu reduces after insertion of ksharsutra in fistula in ano on 7th day,14thday,21st day,28th day,35th day,42th day,49th day,56th day. |
56 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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 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
|
The Fistula usually originates from a perianal abscess in the Intersphincteric space of the anal canal from infection of the anal gland as the anal gland is situated deep to the internal sphincter to open in the Crypts of Morgagni situated on the dentate line. stasis and secondary infection lead to abscess formation and open into the anal canal and the abscess usually tracks down and opens in the perianal skin externally thus Fistula-in-Ano is formed.
Fistula-in-Ano is a track that has 2 opening external and internal. External opening is considered a secondary opening present at the perianal of the skin while Internal is considered a primary opening present in the anal canal. The study will be conducted on 92 diagnosed patients of Bhagandar I.e., Fistula-in-Ano.
Screening of patients for inclusion
Initial Assessment for Patient Selection
Informed written consent
Randomization and group Allocation
Trial group (A) 46 Patients- Nimba Ksharsutra
Control group(B) 46 Patients -Apamarg Ksharsutra
Follow up for assessment (For a maximum of 8 weeks)
Observation & Results will be noted
Statistical analysis
Discussion and Conclusion |