| CTRI Number |
CTRI/2018/08/015236 [Registered on: 08/08/2018] Trial Registered Prospectively |
| Last Modified On: |
30/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Anal Fistula management with Standardized Ksharasutras |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL ASSESSMENT OF STANDARDIZED KSHARASOOTRA WITH AND WITHOUT SNUHI KSHARA IN THE MANAGEMENT OF BHAGANDARA W.S.R. 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 FORAM JOSHI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Gujarat Ayurved University |
| Address |
DEPARTMENT OF SHALYATANTRA
JS AYURVED MAHAVIDHYALAYA COLLEGE ROAD
NADIAD
Gujarat Ayurved University
Hospital Road
Jamnagar
361008
Jamnagar
GUJARAT
387001
India |
| Phone |
9924468211 |
| Fax |
|
| Email |
dr.foramj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR FORAM JOSHI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Gujarat Ayurved University |
| Address |
SHALYATANTRA DEPARTMENT JS AYURVED MAHAVIDHYALAYA COLLEGE ROAD NADIAD
Gujarat Ayurved University
Hospital Road
Jamnagar
361008
Jamnagar
GUJARAT
387001
India |
| Phone |
9924468211 |
| Fax |
|
| Email |
dr.foramj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR FORAM JOSHI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
JS AYURVED MAHAVIDHYALAYA AND PD PATEL AYURVED HOSPITAL |
| Address |
SHALYATANTRA DEPARTMENT JS AYURVED MAHAVIDHYALAYA COLLEGE ROAD NADIAD
Kheda
GUJARAT
387001
India |
| Phone |
9924468211 |
| Fax |
|
| Email |
dr.foramj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahabharat Medical society Nadiad Gujarat |
|
|
Primary Sponsor
|
| Name |
JS AYURVED MAHAVIDHYALAYA NADIAD |
| Address |
SHALYATANTRA DEPARTMENT JS AYURVED MAHAVIDHYALAYA COLLEGE ROAD NADIAD |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Foram Joshi |
JS Ayurved Mahavidyalay and PD Patel Ayurved Hospital Nadiad Gujarat India |
Dr Foram Joshi
Department of Shalyatantra
JS Ayurved Mahavidyalaya and
PD Patel Ayurved Hospital College Road Nadiad 387001
Kheda
GUJARAT |
9924468211
dr.foramj@gmail.com |
| Dr Foram Joshi |
OPD SHALYATANTRA 136 |
Room no 136
OPD building
PD PATEL AYURVED HOSPITAL NADIAD
Kheda
GUJARAT |
9924468211
dr.foramj@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
DIAGNOSED CASES OF LOW ANAL FISTULA IN ANO, (1) ICD-10 Condition: K629||Disease of anus and rectum, unspecified, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standardized Kshara sootra with snoohi kshara threading in fistula tract |
By primary threading method and then change of thread on 7 days interval by rail road method till complete cut through of fistula tract |
| Intervention |
Standardized Kshara sootra without snoohi kahata threading in fistula tract |
By primary threading method and then change of thread on 7 days interval with rail road method till complete cut through of fistula tract
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 All types of low anal fistula in ano (Vataja, Pittaja, Kaphaja, Vata-Pittaja, Vata-Kaphaja and Arsho-Bhagandara (Kapha-Pittaja)
2 Fistula in ano with controlled TB, DM, Hypertension
|
|
| ExclusionCriteria |
| Details |
1 Sannipaataja and Agantuja Bhagandara
2 Fistula other than fistula-in-ano.
3 High anal fistula in ano.
4 Fistula associated with uncontrolled TB, DM, Hypertension or Osteomyelitis, Venereal Disease, Pregnancy, Chronic or acute ulcerative colitis, Crohn’s disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of fistula in ano and complete cure |
30 to 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Optimum working device from two types of ksharasutra in the management of fistula in ano by Ayurved |
30 to 60 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
21/08/2018 |
| 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="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
Publication Details
Modification(s)
|
1 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Bhagandara is one among the eight Mahaagadas described by Maharshi Sushruta. Acharya Sushruta has mentioned that all types of Bhagandara are difficult to treat. In modern medicine, a fistula-in-ano is an abnormal communicating tract between anal canal and peri-anal skin. It is also known for its significant risk of recurrence (0.7–26.5%) and high risk of impaired continence (5–40%) in modern surgery. Basing upon the clinical manifestations, fistula in ano can be correlated with Bhagandara clinical entity described by Acharya Sushruta. Ksharsootra is a very well -known alternative therapy for the management of Fistula-in-ano.In present study, Snuhi Kshara is selected on the basis of its Tikshna property to evaluate their clinical efficacy in fistula-in-ano and classical Snuhi Ksheera based Ksharsootra to evaluate its clinical efficacy in the management of fistula in ano. The Indian Council of Medical Research (ICMR) has validated it and WHO has accepted the effectiveness of this an Ayurvedic treatment modality in treating fistula in ano. So, Standardization of Kshara and Ksharsootra are prime need before their clinical application. This study has been planned for standardization of Snuhi Kshara, Ksharsootra and their comparative clinical assessment in the management of Bhagandara (fistula-in-ano). |