| CTRI Number |
CTRI/2021/07/034782 [Registered on: 12/07/2021] Trial Registered Prospectively |
| Last Modified On: |
22/11/2022 |
| 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
|
Comparative Study of Anal Dilatation with External Lateral Sphincterotomy in the Management of
Fissure in Ano
|
|
Scientific Title of Study
|
Comparative Study of Anal Dilatation with External Lateral Sphincterotomy in the Management of
Fissure 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 Bharat Oza |
| Designation |
Associate Professor, Shalyatantra Department |
| Affiliation |
PDEAS College of Ayurved and Research Center |
| Address |
PDEAS College of Ayurved and Research Center, Sector No 25,
NigdiPradhikaran, Pimpri Chinchwad, Pune - 411044 Pune
MAHARASHTRA 411044
Pune
MAHARASHTRA
411044
Pune
MAHARASHTRA
411004
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat Oza |
| Designation |
Associate Professor, Shalyatantra Department |
| Affiliation |
PDEAS College of Ayurved and Research Center |
| Address |
PDEAS College of Ayurved and Research Center, Sector No 25,
NigdiPradhikaran, Pimpri Chinchwad, Pune - 411044 Pune
MAHARASHTRA 411044
Pune
MAHARASHTRA
PDEAS College of Ayurved and Research Center, Sector No 25,
NigdiPradhikaran, Pimpri Chinchwad, Pune - 411044 Pune
MAHARASHTRA 411044
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat Oza |
| Designation |
Associate Professor, Shalyatantra Department |
| Affiliation |
PDEAS College of Ayurved and Research Center |
| Address |
PDEAS College of Ayurved and Research Center, Sector No 25,
NigdiPradhikaran, Pimpri Chinchwad, Pune - 411044 Pune
MAHARASHTRA 411044
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| PDEAS College of Ayurved and Research Center, Sector No 25,
NigdiPradhikaran, Pimpri Chinchwad, Pune - 411044 Pune
MAHARASHTRA 411044 Pune MAHARASHTRA PDEAS College of
Ayurved and Research Center, Sector No 25, NigdiPradhikaran,
Pimpri Chinchwad, Pune - 411044 Pune MAHARASHTRA 411044
Pune MAHARASHTRA
Pune
MAHARASH |
|
|
Primary Sponsor
|
| Name |
PDEAS College of Ayurved and Research Center |
| Address |
PDEAS College of Ayurved and Research Center, Sector No 25, Nigdi Pradhikaran,
PimpriChinchwad, Pune - 411044 |
| 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 |
| DrVishal Kotgir |
PDEAS College of Ayurved and Research Center |
Deapratment of Shalyatantra PDEAS College of Ayurved and Research Center, Sector No 25,
Nigdi Pradhikaran, PimpriChinchwad, Pune - 411044
Pune
MAHARASHTRA |
9923522187
drvishalkotgir@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. Ayurveda Condition: PARIKARTIKA, (2) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anal Dilatation Alternate day for a week |
Historically, under general or local anesthesia, manual anal sphincter dilatation is done to reduce sphincter tone and is a general procedure in the treatment of chronic anal fissure. Weekly alternate day |
| Comparator Agent |
External Lateral Sphincterotomy under local anesthesia done once. |
External Lateral anal sphincterotomy has been accepted as the gold standard treatment for chronic fissures. It will be done under local anesthesia for once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of within age of 18 - 60 year of either sex.
The patient who are having classical signs and symptoms of acute fissure in ano will be selected for present clinical study.
Patient are ready to give informed consent.
After screening for covid 19 in covid-19 screening opd , pt will be selected
|
|
| ExclusionCriteria |
| Details |
Patients having Parikartika (Fissure-in-ano) secondary to Ulcerative colitis, Syphilis, Crohn’s disease, Tuberculosis and Ca of rectum and anal canal. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of anal dilatation and
external lateral sphincterotomy in fissure |
It will assessed on 15 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To get relief from fissure in ano |
To relief from fissure in ano within 30 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2021 |
| 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
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anal Fissure is one of the major causes for pain in anal region.In this study. Patients attending OPD/IPD of Shalya and suffering from acute fissure will be recruited from age group 18-60 years.Screening of subjects according to baseline assessment & inclusion & exclusion criteria.A well written informed consent will be obtained from all the participants explaining the details about the treatments or procedure done on them. Aim of study is To compare the efficacy of anal dilatation and external lateral sphincterotomy in fissure. Anal dilatation and External lateral anal sphincterotomy are the intervention.External Lateral anal sphincterotomy has been accepted as the gold standard treatment for chronic fissures. Sushruta had also mentioned therapeutic procedures.Shastra karma for fissure. Regarding Parikartika , a lot of previously work has been done on various local as well as oral medication like Jatyadi Ghruta, Pichh Basti, Vataharan Taila, Basti Nirgundyadi Malhar, Dashmuladi Kwath etc.. But it has been observed that Anal dilatation and External lateral anal sphincterotomy has not been been studied earlier that’s why this study would be having newer outcome in the management of fissure in ano |