| CTRI Number |
CTRI/2021/04/033137 [Registered on: 27/04/2021] Trial Registered Prospectively |
| Last Modified On: |
26/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [SLOFT Technique] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Scraping and Agnikarma in Fistula in ano |
|
Scientific Title of Study
|
A CLINICAL STUDY OF SUBMUCOSAL LIGATION OF FISTULA TRACT (SLOFT) FOLLOWED BY LEKHAN KARMA AND AGNIKARMA IN THE MANAGEMENT OF BHAGANDAR (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 Deepshikha Meena |
| Designation |
MS Scholar of PG Department of Shalya Tantra |
| Affiliation |
Dr.Sarvepalli radhakrishnan rajasthan ayurveda university jodhpur |
| Address |
Room no.135 PG Department of Shalya tantra Dr.Sarvepalli radhakrishnan rajasthan ayurveda university jodhpur
Room no.135 PG Department of Shalya tantra Dr.Sarvepalli radhakrishnan rajasthan ayurveda university jodhpur
Jodhpur
RAJASTHAN
342304
India |
| Phone |
9782599085 |
| Fax |
|
| Email |
dm12071993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rajesh Kumar Gupta |
| Designation |
Professor and H.O.D. of PG Department of shalya tantra |
| Affiliation |
Dr.Sarvepalli radhakrishnan rajasthan ayurveda university jodhpur |
| Address |
Room no.135 PG Department of Shalya tantra Dr.Sarvepalli radhakrishnan rajasthan ayurveda university jodhpur
Room no.135 PG Department of Shalya tantra Dr.Sarvepalli radhakrishnan rajasthan ayurveda university jodhpur
Jodhpur
RAJASTHAN
342304
India |
| Phone |
9636520573 |
| Fax |
|
| Email |
guptadrrajeshkumargupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepshikha Meena |
| Designation |
MS Scholar of PG Department of Shalya Tantra |
| Affiliation |
Dr.Sarvepalli radhakrishnan rajasthan ayurveda university jodhpur |
| Address |
Room no.135 PG Department of Shalya tantra Dr.Sarvepalli radhakrishnan rajasthan ayurveda university jodhpur
Room no.135 PG Department of Shalya tantra Dr.Sarvepalli radhakrishnan rajasthan ayurveda university jodhpur
Jodhpur
RAJASTHAN
342304
India |
| Phone |
9782599085 |
| Fax |
|
| Email |
dm12071993@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No.14 DRSRRAU Hospital Jodhpur |
|
|
Primary Sponsor
|
| Name |
DRSRRAU Jodhpur Rajasthan |
| Address |
P.G. Department of Shalya Tantra Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University,Jodhpur. |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| ProfRajesh Kumar Gupta |
DRSRRAU Karwar Jodhpur |
OPD No.14 PG Department of shalya tantra DSRRAU Hospital Jodhpur
Jodhpur
RAJASTHAN |
9636520573
guptadrrajeshkumargupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional ethics committee DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: Bhagandar, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
SLOFT Technique in Bhagandar |
Submucosal ligation of fistula tract(SLOFT)followed by lekhan karma and agnikarma in the management of bhagandar |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Cryptoglandular fistula. 2.Multiplte tract of fistula 3.Abscess fistula complex. 4.High-transsphincteric. 5. Horseshoe-transsphincteric. 6.Suprasphincteric |
|
| ExclusionCriteria |
| Details |
1-Ulcerative colitis.
2-Hypertension.
3-Urinary tract infection.
4-Any malignancies.
5-HIV & HBsAg positive.
6-Tuberculosis
7-Non crypto glandular fistula in anus. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| patient may assessed by subjective parameters |
12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efficacy of “SLOFT†technique followed by Lekhan karma & Agnikarma in the management of Bhagandar. |
12 month |
|
|
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 |
|
Date of First Enrollment (India)
|
28/04/2021 |
| 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="0"
Months="10"
Days="2" |
|
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
|
Anorectal disorders are a group of medical disorders that occur at the junction of the anal canal and the rectum. Fistula-in-ano (Bhagandara) is one of the most common ano rectal diseases. Shalya Tantra offers different therapeutic measures for the management of Anorectal disorder ;Bhagandara (Anal Fistula) such as; Ghrita, Pichu, Pratisaraniya Kshara, Tail Daha, Vedana-Sthapana Mahakashaya Ghanavati, Kshar Sutra and Tankan Kshar Sutra. These therapies offer Vata-pitta shaman, jantu-ghna & shotha-nashaka properties thus helps in the management of Anorectal disorders.The formation of a pidika leads development of Bhagandar characterized by opening around gud pradesh along with painful pus discharge. Many samhitas have description of AgniKarma as we know Agnikarma in classical. Ayurveda is a generalized therapeutic procedure, which can be useful in various disorders(Arsh, bhagandar, parikartika etc.) and also at an emergency,which are doing for some particular conditions. Agnikarma is easy and quick procedure to perform and also effective. AgniKarma is one of the fast procedure to reduced vedana (pain).SLOFT (submucosal ligation of fistula tract) is a modification of LIFT. LIFT is associated with high recurrence and is technically difficult. LIFT has higher chances of intersphincteric abscess, has chances of internal sphincter damage and leaves an external scar. SLOFT (Submucosal ligationof fistulous tract ) is easy to learn and teach, has lesser complications, early recovery, minimal incontinence and cost-effective. |