| CTRI Number |
CTRI/2015/03/005645 [Registered on: 18/03/2015] Trial Registered Retrospectively |
| Last Modified On: |
07/11/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Ayurveda
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY TO KNOW THE EFFICACY OF THREAD PREPARED WITH THE PLANTS IN PATIENTS WITH BHAGANDARA - A TRACT FORMS IN THE ANAL REGION DUE TO INFECTIONS. |
|
Scientific Title of Study
|
“A COMPARATIVE STUDY OF CHITRAKA KSHARA SUTRA AND APAMARGA KSHARA SUTRA IN BHAGANDARA W.S.R. TO FISTULA-IN-ANO |
| Trial Acronym |
ACFIA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 03_A026_50883 |
Other |
| SKAMC/104 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satender Tanwar |
| Designation |
PG SHOLAR |
| Affiliation |
SKAMCH AND RC |
| Address |
DR SATENDER TANWAR S/O SH RAM KUNWAR TANWAR VPO KHARAK KALAN PANA KHANDYAN DISTRICT AND TEHSIL BHIWANI HARYANA
VPO KHARAK KALAN PANA KHANDYAN DISTRICT AND TEHSIL BHIWANI HARYANA PIN 127114
Bhiwani
HARYANA
127114
India |
| Phone |
7676067600 |
| Fax |
|
| Email |
drsatendertanwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAILAJA SV |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT OF PG STUDIES IN SHALYA TANTRA |
| Affiliation |
SKAMCH AND RC |
| Address |
SKAMCHOSPITAL AND RESEARCH CENTER RPC LAYOUT VIJAYANAGAR 2nd STAGE PIPE LINE ROAD
SKAMCHOSPITAL AND RESEARCH CENTER RPC LAYOUT VIJAYANAGAR 2nd STAGE PIPE LINE ROAD PIN 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9880917253 |
| Fax |
|
| Email |
shailajaramkumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satender Tanwar |
| Designation |
PG SHOLAR |
| Affiliation |
SKAMCH AND RC |
| Address |
SKAMCH AND RC RPC LAYOUT VIJAYANAGAR 2nd STAGE PIPE LINE ROAD
SKAMCH AND RC RPC LAYOUT VIJAYANAGAR 2nd STAGE PIPE LINE ROAD PIN 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
7676067600 |
| Fax |
|
| Email |
drsatendertanwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| SKAMCH AND RC RPC LAYOUT VIJAYANAGAR 2nd STAGE PIPE LINE ROAD BANGALORE KARNATAKA |
|
|
Primary Sponsor
|
| Name |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
PG SCHOLAR IN DEPT OF PG STUDIES IN SHALYA TANTRA SKAMCH AND RC RPC LAYOUT VIJAYANAGAR 2nd STAGE PIPE LINE ROAD |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SKAMCH AND RC RESEARCH COMITTIE |
SKAMC HOSPITAL AND RESEARCH CENTER PIPE LINE ROAD RPC LAYOUT VIJAYANAGAR BANGALORE KARNATAKA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SATENDER TANWAR |
SKAMC HOSPITAL AND RESEARCH CENTER |
SKAMCH AND RC RPC LAYOUT VIJAYANAGAR 2nd STAGE PIPE LINE ROAD
KSHARA SUTRA DEPARTMENT
2ND FLOOR IN THE HOSPITAL BUILDING AND PATIENTS RECEIVED IN OPD OF SHALYA TANTRA IN ROOM NO. 5
SKAMCH AND RC RPC LAYOUT VIJAYANAGAR 2nd STAGE PIPE LINE ROAD PIN 560104
Bangalore
KARNATAKA
560104
India
Bangalore
KARNATAKA |
7676067600
drsatendertanwar@gmail.com |
| DR SHAILAJA SV |
SKAMC HOSPITAL AND RESEARCH CENTER |
SKAMCH AND RC RPC LAYOUT VIJAYANAGAR 2nd STAGE PIPE LINE ROAD SKAMCH AND RC RPC LAYOUT VIJAYANAGAR 2nd STAGE PIPE LINE ROAD PIN 560104
Bangalore
KARNATAKA |
9880917253
shailajaramkumar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMC HOSPITAL AND RESEARCH CENTERC IISTITUTIONAL ETHICAL COMMITTIE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Lakshanas of the Bhagandara.
Clinical feature of Fistula-in –Ano.
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
APAMARGA AND CHITRAKA BASED KSHARA SUTRA PREAPED AS PER STANDARD PROTOCOL |
To evaluate the efficacy of Chitraka kshara sutra in the management of Bhagandara.
To Evaluate the efficacy of Apamarga kshara sutra in the management of Bhagandara.
To compare the efficacy of Chitraka Kshara sutra and Apamarga kshara sutra in the management of Bhagandara.
|
| Intervention |
APAMARGA KSHAR SUTRA |
LENGTH OF TRACT AS PER THE TRACT OF FISTULA LENGTH
THE FREQUENCY OF CHANGE OF THREAD IS EVERY WEEK AND POSTPONED IF ANY SYSTEMIC INFECTION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Bhagandara (Fistula- in-Ano) suitable for Kshara sutra karma.
Patients of either sex aged between 18 to 65 years.
|
|
| ExclusionCriteria |
| Details |
Patients below the age of 18 years and above the age of 65 years.
Patients with other Systemic disease interfering with the treatment.
Multiple opening in perianal region.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WITH CHANGE OF EACH THREAD THE LENGTH OF FISTULOUS TRACT CAN BE REDUCED UP TO 8MM TO 12MM |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/01/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
INTERNATIONAL JOURNAL OF BIOASSAYSISSNb 2278 778XCODEN IJBNHYCASE REPORTOPEN ACCESS Corresponding Author Dr Satender Tanwar Junior Resident Department of Post Graduate Studies Shalya Tantra Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center Vijayanagar Bangalore Karnataka India 3766 KSHARA SUTRA BOON FOR CARDIAC PATIENTS WITH FISTULA IN ANO Satender Tanwar and Shailaja SVDepartment of Post Graduate Studie Shalya Tantra Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center Vijayanagar Bangalore Karnataka India Received for publication January17 2015 Revised January19 2015 Accepted February21 201 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
PATIENTS ARE UNDER TRIAL IN BOTH THE GROUPS DRUG PREPARATION DONE FOR ONE GROUP FOR ANOTHER GROUP PREPARATION IS GOING ON UNDER HEAD OF INSTITUTION AND HEAD OF DEPARTMENT SUPERVISION.
|