| CTRI Number |
CTRI/2024/01/061250 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
clinical comparitive study of Apamarga sadhyaksharasutra and Apamarga conventionalksharasutra in fistula in ano. |
|
Scientific Title of Study
|
A RANDOMIZED CLINICAL TRIAL TO COMPARE APAMARGA SADHYAKSHARASUTRA AND CONVENTIONAL APAMARGA KSHARASUTRA IN UNIT CUTTING TIME OF FISTULOUS TRACT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. ATHULYAA |
| Designation |
ASSISSTANT PROFESSOR |
| Affiliation |
P.N.N.M AYURVEDA MEDICAL COLLEGE |
| Address |
P.N.N.M AYURVEDIC MEDICAL COLLEGE AND HOSPITAL
CHERUTHURUTHI P. O
SHORANUR
TRISSUR
KERALA
P.N.N.M AYURVEDIC MEDICAL COLLEGE AND HOSPITAL
CHERUTHURUTHI P. O
SHORANUR
TRISSUR
KERALA
Thrissur
KERALA
679531
India |
| Phone |
9072348167 |
| Fax |
|
| Email |
athulyaarun87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Chavan Dnyanshwar Dattarao |
| Designation |
ASSOCIATE PROFESSOR &H.O.D |
| Affiliation |
ASSOCIATE PROFESSOR & H.O.D |
| Address |
DEPARTMENT OF SHALYATANTRA
Y.M. T. MEDICAL COLLEGE AND HOSPITAL
KHARGHAR
SECTOR 4
NAVIMUMBAI
DEPARTMENT OF SHALYATANTRA
Y.M. T. MEDICAL COLLEGE AND HOSPITAL
KHARGHAR
SECTOR 4
NAVIMUMBAI
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9822221585 |
| Fax |
|
| Email |
dnyanesh7373@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. ATHULYA. A |
| Designation |
ASSISSTANT PROFESSOR |
| Affiliation |
P.N.N.M AYURVEDA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF SHALYATANTRA
P.N.N.M AYURVEDIC MEDICAL COLLEGE AND HOSPITAL
CHERUTHURUTHI P. O
SHORANUR
TRISSUR
KERALA
CHERUTHURUTHI P. O
SHORANUR
TRISSUR
KERALA
Thrissur
KERALA
679531
India |
| Phone |
9072348167 |
| Fax |
|
| Email |
athulyaarun87@gmail.com |
|
|
Source of Monetary or Material Support
|
| YERALA MEDICAL TRUST AYURVEDIC MAHAVIDYALAYAM
|
|
|
Primary Sponsor
|
| Name |
YERLA MEDICAL TRUST AYURVEDIC MAHAVIDYALAYAM |
| Address |
SECTOR 4
INSTITUTIONAL AREA
NAVIMUMBAI
410210 |
| 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 |
| Dr ATHULYA A |
Y. M. T. AYURVEDIC MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF SHALYATANTRA NAVI MUMBAI
KHARGHAR
SECTOR 4
410210
INSTITUTIONAL AREA
Mumbai
MAHARASHTRA |
9072348167
athulyaarun87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. D.G.POL FOUNDATION S INSTITUTE FOR RESEARCH AND POST GRADUATION IN AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: susruta samhita, Procedure details: ksharasutra ligation conventional apamarga ksharasutra)
(1) Medicine Name: chiruvilvadi kashaya, Reference: sahasrayoga, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: bd, Duration: 28 Days | | 2 | Intervention Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: ashtanga hridaya, Procedure details: sadyaksharasutra ligation on alternative days on fistula)
(1) Medicine Name: chiruvilwadi kashaya, Reference: sahasrayoga, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: bd, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Diagnosed cases of fistula-in-ano.
• Single tract fistula.
• Both high and low anal fistula |
|
| ExclusionCriteria |
| Details |
Uncontrolled diabetes mellitus, hypertension and other known systemic
illnesses.
• Fistula without external opening
• Fistula secondary to systemic diseases (tuberculosis, Crohn’s disease,
ulcerative colitis, PCOD, metabolic disorders) with multiple tract.
• Bleeding disorders, HIV, HBsAg, contagious diseases and carcinomas. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| unit cutting time |
28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain |
every 3rd day for 1month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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 Yet Recruiting |
| 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
|
The present study is undertaken to overcome and compare the limitations of the conventional ksharasutras with sadyaksharasutra, like difficulty in the preparation and preservation of ksharasutra, prolonged cutting time and long standing severe pain following ksharasutra application. As surgery is considered essential in many cases of fistula-in-ano, but due to increased chances of recurrence, ksharasutra becomes their last resort. The main objective of the present study is to attain a fast cutting time with minimal complications and to shorten the whole treatment duration. Kshara is prepared from Apamarga (Achyranthes aspera) . As Apamarga kshara is used for making sadyaksharasutra, it is beneficial in two ways, one by not developing any skin irritation / allergic reactions and the other by improving cutting along with healing. |