| CTRI Number |
CTRI/2020/11/029087 [Registered on: 12/11/2020] Trial Registered Prospectively |
| Last Modified On: |
05/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY KANER KSHARSUTRA IN THE TREATMENT OF BHAGANDARA. |
|
Scientific Title of Study
|
"RANDOMIZED, OPEN LABELED, CONTROLLED CLINICAL STUDY OF EFFICACY OF ASHWAMAR KSHARSUTRA IN THE MANAGEMENT OF BHAGANDARA WITH SPECIAL REFERENCE TO FISTULA IN ANO". |
| Trial Acronym |
ROLCCSAKBF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sapna Jagdish Pawar |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved college and Hospital Nanded |
| Address |
Shalyatantra Department Government Ayurved College and Hospital
Vazirabad
Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
8408904733 |
| Fax |
|
| Email |
sapnapawar23422@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Amilkanthawar |
| Designation |
Associate Professor and Guide |
| Affiliation |
Government Ayurved college and Hospital Nanded |
| Address |
Shalyatantra Department Government Ayurved College and Hospital
Vazirabad
Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9890569621 |
| Fax |
|
| Email |
drarajendrah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajendra Amilkanthawar |
| Designation |
Associate Professor and Guide |
| Affiliation |
Government Ayurved college and Hospital Nanded |
| Address |
Shalyatantra Department Government Ayurved College and Hospital
Vazirabad
Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9890569621 |
| Fax |
|
| Email |
drarajendrah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra
Government Ayurved College and Hospital, Nanded |
|
|
Primary Sponsor
|
| Name |
Dr Sapna Pawar |
| Address |
Shalyatantra Department Government Ayurved college and Hospital Vazirabad Nanded |
| Type of Sponsor |
Other [Self] |
|
|
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 Rajendra Amilkanthwar |
Government Ayurved college and Hospital |
Opd No.6 Shalyatantra Department,Government Ayurved college and Hospital
Vazirabad
Nanded
Nanded
MAHARASHTRA |
9890569621
drarajendrah@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: K603||Anal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Apamarga Ksharsutra |
Route of Administration: Under all aseptic precautions ksharsutra ligation will be done locally and ksharasutra will be changed every week.
Duration: 8 weeks |
| Intervention |
Ashwamar Ksharasutra |
Route of Administration: Under all aseptic precautions locally ksharsutra ligation will be done and ksharasutra will be changed every week.
Duration: 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as case of fistula in ano specially low fistula in ano with one or two external openings
The fistulous tract length having 3 to 8 cm |
|
| ExclusionCriteria |
| Details |
Carcinoma of rectum
Pregnancy
Patient suffering from any systematic disease like uncontrolled HTN,DM,TB,CVS,HIV positive etc
Patients having other perianal or Rectal diseases
Patients with Multiple fistula,Patients with high anal fistula
Acute and chronic ulcerative colitis
Other major disease related anorectal |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out healing and cutting rate of Ashwamar ksharasutra of the fistulous track |
8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out effects of Ashwamar ksharasutra on symptoms of fistula like pus discharge itching burning tenderness |
8 week |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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 |
|
Date of First Enrollment (India)
|
01/12/2020 |
| 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="0"
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
|
"This Study Is Randomized Open Labeled Controlled Clinical Study Of Efficacy Of Ashwamar Ksharsutra In The Management Of Bhagandara With Special Reference To Fistula In Ano" For 8 Weeks And Follow up And Assessment On Every Week.This Study Is Conducted As Compulsory Part Of Pg Course At Single Centre.Primary Outcome Is To Find Out Healing And Cutting Rate Of Ashwamar Ksharsutra Of The Fistulous track. |