| CTRI Number |
CTRI/2024/01/061922 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of chronic fissure in ano by Agnikarma or Lateral sphincterotomy |
|
Scientific Title of Study
|
A Randomized Comparative clinical Study of Agnikarma & Lateral Sphincterotomy in Chronic Fissure 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.Sanjay Trivedi |
| Designation |
Professor |
| Affiliation |
Govindbhai Jorabhai.Patel institute of Ayurvedic studies and research Anand |
| Address |
Department of shalya tantra, Govindbhai Jorabhai Patel Institute of Ayurvedic Studies and research, New Vallabha Vidhyanagar ,Anand. Gujarat 388121
Anand
GUJARAT
388121
India |
| Phone |
9428628046 |
| Fax |
|
| Email |
drsanjaytrivedi888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Hemanth Toshikhane |
| Designation |
Dean and Professor |
| Affiliation |
Parul University, Vadodara |
| Address |
Parul Institute of Ayurveda, Parul University, Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
hemant.toshikhane@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Sanjay Trivedi |
| Designation |
Professor |
| Affiliation |
Govindbhai Jorabhai Patel Institute of Ayurvedic Studies and Research, Anand |
| Address |
Department of Shalya Tantra,
Room number- 401
Govindbhai Jorabhai Patel Institute of Ayurvedic Studies and Research, New Vallabha Vidhyanagar, Anand, Gujarat
Anand
GUJARAT
388121
India |
| Phone |
9428628046 |
| Fax |
|
| Email |
drsanjaytrivedi888@gmail.com |
|
|
Source of Monetary or Material Support
|
| Surajben Govindbhai Patel Ayurveda Hospital and Maternity Home, New Vallabha Vidhyanagar, Anand |
|
|
Primary Sponsor
|
| Name |
Dr Sanjay Trivedi |
| Address |
Dr.Sanjay Trivedi,
B1 Staff Quarter Ayurvedic Collage, ADIT Campus, New Vallabha Vidhyanagar Anand, Gujarat |
| 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 Sanjay Trivedi |
Surajben Govindbhai Patel Ayurvedic Hospital and Maternity Home |
Romm no.25, Shalya Tantra Department, Surajben Govindbhai Patel Ayurvedic Hospital and Maternity Home, New Vallabh Vidhyanagar, Anand
Anand
GUJARAT |
9428628046
drsanjaytrivedi888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional ethical committee G,J,Patel institute of Ayurvedic studies and research Anand |
Approved |
| Institutional ethical committee Parul institute of ayurveda parul university |
Approved |
| NOC FROM HOSPITAL |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K601||Chronic anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Samhita Sutra Sthan 12, Procedure details: Under Suitable Anesthesia, Patient will be taken in Lithotomy position, Sentinel tag will be catched with Allies forceps & then Posterior midline along with fissure bed will be cauterized with the help of cervical thermal cautery(Agnikarma with cervical cautery instrument), this procedure will be done in single sitting.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Lateral Sphincterotomy | Under suitable Anesthesia, Patient will be taken in Lithotomy position, then With a finger in the anal canal, an 11-blade scalpel is inserted into the intersphincteric plane, ensuring to stay below the dentate line. The blade is then moved medially dividing the internal sphincter. The incision is left open to allow for healing by secondary intention. This procedure will be done in single sitting. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from chronic anal fissure with or without sentinel pile.
Patients suffering from chronic anal fissure without piles.
|
|
| ExclusionCriteria |
| Details |
Patients having anal carcinoma, papilloma, ulcerative colitis, Crohn’s disease, syphilitic fissure, tubercular ulcer & fistula.
Patients having other systemic pathology (TB, DM, HIV, HBsAg, etc).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief Pain
Relief in constipation |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healing of chronic fissure |
21 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
12/02/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
In modern medicine the standard treatment for the anal
fissure is anal dilatation, infiltration and local applications. In some cases
where the patient is not relieved by the above therapy and unsatisfactory
conservative treatment; leads to chronicity of anal fissure which still remain
as an enigma. In such cases Fissurectomy and Sphinterotomy is the treatment of
choice in modern surgery but the modern surgical techniques permanently weakens
the internal sphincter, which leads to anal incontinence. Hence the assessment
of relative efficacy of different therapy is require for the treatment of
chronic anal fissure, with no chance of recurrence i.e. treatment of chronic
anal fissure by Agnikarma |