| CTRI Number |
CTRI/2022/01/039220 [Registered on: 06/01/2022] Trial Registered Prospectively |
| Last Modified On: |
04/12/2021 |
| 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
|
Management of Fistula with Apamarga Ksharjala infiltration and Apamarga Kshar sootra |
|
Scientific Title of Study
|
Efficacy of Agnikarma with Apamarga Ksharjalpoorana and Apamarga Ksharsootra application in the management of Bhagandara(Fistula-in-ano)- An open labelled Randomized comparative clinical trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PATEL PRAGATI SATISHBHAI |
| Designation |
MS 1ST YEAR |
| Affiliation |
ITRA JAMNAGAR |
| Address |
SHALYA TANTRA DEPARTMENT 6TH FLOOR ITRA JAMNAGAR OPD 1 ITRA JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9998243520 |
| Fax |
|
| Email |
pragatispatel0210@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR T S DUDHAMAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ITRA JAMNAGAR |
| Address |
SHALYA TANTRA DEPARTMENT 6TH FLOOR ITRA JAMNAGAR OPD 1 ITRA JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR T S DUDHAMAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ITRA JAMNAGAR |
| Address |
SHALYA TANTRA DEPARTMENT 6TH FLOOR ITRA JAMNAGAR OPD 1 ITRA JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of teaching and research in Ayurveda GUJARAT AYURVED UNIVERSITY JAMNAGAR |
|
|
Primary Sponsor
|
| Name |
Institute of teaching and research in Ayurveda Jamnagar Gujarat |
| Address |
ITRA JAMNAGAR |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Patel Pragati S |
OPD Number 1 and IPD of Shalya Tantra Department ITRA Hospital Jamnagar |
ITRA Jamnagar
Jamnagar
GUJARAT |
9998243520
pragatispatel0210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: Patients, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Agnikarma with Apamarga Ksharjala poorana and Apamarga Ksharsootra application | (Procedure Reference: Chakradatta Arsha Adhikar, Procedure details: After patency test tract will be curetted well and then Apamarga ksharjala will be infiltrated in the tract and it would be in the tract for 100 seconds and then the tract will be washed with Nimbu swarasa
A Nimbu swarasa cotton swab will be placed in the internal opening during this procedure
Internal opening will be dagdha with Swarna Shalaka)
| | 2 | Comparator Arm | Procedure | - | Apamarga Ksharsootra Application | (Procedure Reference: Chakradatta Arsha Adhikar , Procedure details: After patency of tract with the help of probe Apamarga Kshar sootra will be ligated in Fistula track )
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms of Bhagandara like Pidika, Srava, Vedana, Kandu
Diagnosed cases of low anal single tract Inter-Sphincteric and Trans-Sphincteric Fistula-in-ano
Medically fit for surgery irrespective of sex, caste, religion and occupation |
|
| ExclusionCriteria |
| Details |
Patients below 18 years of age and above 70 years of age
Fistula-in-Ano with multiple tracks
Fistula-in-Ano associated with Piles and Fissure
Crohn’s disease
Patient with Diabetes Mellitus : FBS: >140 mg/dl, PPBS: >180mg/dl
Patient with Hypertension : Systolic BP:>140mmHg, Diastolic BP: >90 mmHg
Cardiovascular disease
Pregnancy
Malignancy
Rectal prolapse
Hepatitis B, Tuberculosis, HIV, HCV& VDRL positive cases
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To reduce the reccurrence rate of the Fistula-in-ano
To minimize the post operative pain
To minimize the duration of treatment |
upto complete tract healing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improve quality of life of person |
upto complete tract healing |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/02/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Fistula-in-Ano is a common anorectal condition in the populations worldwide and its prevalence is second highest after haemorrhoids. Bhagandara (Fistula-in-Ano) is said callous to be cured and considered under the Ashta Maharogas (Eight grave disorders). Kshara is one of the chief drug in the preparation of Kshar-sootra which is gaining worldwide acceptance today. Present study will be carried out to check the efficacy of Apamarga Ksharjalapooran in Fistula-in-Ano. Ø Materials and Methods: In the present study total 30 clinically diagnosed patients having sign and symptoms of Bhagandara (Pidika, Srava, Vedana and Kandu in Gudapradesha) will be divided in two groups by computer generated randomization. One group of the patients will be treated with Agnikarma with Apamarga Ksharjalpooran and second group of the patients will be treated with Apamarga Kshar-sootra application. Ø Results and Discussion: Data generated during the above study will be present in a systemic manner as shall be analyzed and the section where the important points of the Conceptual study, Analytical study, Pharmacological study will be discussed. Ø Follow up: After completion of therapy, follow up will be done for 2 months to assess the status of patient, where patient will be asked to report. Ø Side Effects: These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not aware of. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar. |