| CTRI Number |
CTRI/2018/11/016343 [Registered on: 15/11/2018] Trial Registered Prospectively |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TREATMENT OF FISTULA-IN-ANO THROUGH KSHARASUTRA THERAPY |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF KUTAJA KSHARASUTRA WITH THAT OF APAMARGA KSHARASUTRA IN MANAGEMENT OF BHAGANDARA (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 SK Gupta |
| Designation |
Professor |
| Affiliation |
Department Of Shalya Tantra, |
| Address |
Department Of Shalya Tantra,
5th Floor Academic Building, All India Institute Of Ayurveda, Gautam PURI Sarita Vihar, Mathura Road
South
DELHI
110076
India |
| Phone |
9871963978 |
| Fax |
|
| Email |
drskgupta17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SK Gupta |
| Designation |
Professor |
| Affiliation |
Department Of Shalya Tantra |
| Address |
Department Of Shalya Tantra,
5th Floor Academic Building, All India Institute Of Ayurveda,
Gautam PURI Sarita Vihar
Mathura Road,
New Delhi-110076
South
DELHI
110076
India |
| Phone |
9871963978 |
| Fax |
|
| Email |
drskgupta17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khushboo |
| Designation |
PG Scholar |
| Affiliation |
Department Of Shalya Tantra |
| Address |
Department Of Shalya Tantra,
5th Floor Academic Building, All India Institute Of Ayurveda,
Gautam PURI Sarita Vihar
Mathura Road,
New Delhi-110076
South
DELHI
110076
India |
| Phone |
8808618850 |
| Fax |
|
| Email |
drkhushboofaridi@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda, Mathura Road, Sarita Vihar, New Delhi - 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda Sarita Vihar ,Gautam Puri, Mathura Road, 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 S K Gupta |
All India Institute Of Ayurveda |
OPD No 105, First Floor, Hospital Block, All India Institute Of Ayurveda Gautam Puri, Sarita Vihar, Mathura Road
South
DELHI |
9871963978
drskgupta17@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: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Apamarga Ksharasutra |
as mentioned in classics Apamarga Ksharasutra will be used |
| Intervention |
Kutaja Ksharasutra |
Kutaja Ksharasutra will be prepared as mentioned in classics and applied in Fistula-In-Ano |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Fistula-In-Ano,age group between 20-70 years irrespective to their, gender,religion,education,& socioeconomic status |
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled tuberculosis, hypertension, DM, Colitis, malignancies and non-crypto glandular fistulae will be rejected. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Unit cutting time and healing length of fistulous tract |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Pain, Discharge and improvement in Quality in Life |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
05/06/2019 |
| 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
|
the thesis work will be publish in reputed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
According to a recent study conducted by Indian Proctology Society the prevalance of anal Fistula in India in a defined population of some states varied from 17%-20%. Despite of so many advancement in medical science, there is no satisfactory treatment available for Fistula in Ano.Ksharasutra is a time tested para-surgical tool for treatment of Fistula in Ano in Ayurveda.
There are so many plants mentioned under the context of Ksharapaka vidhi Adhyaya for preparation of Kshara in Sushruta samhita . Kutaja have the stambhan property so it can be helpful to reduce bleeding and have vilayan, shoshan, and lekhana properties.
Exploration of other plants mentioned by Sushruta for thr preparation of Kshara as a substitute of Apamarga is the need of the hour. |