| CTRI Number |
CTRI/2019/06/019828 [Registered on: 24/06/2019] Trial Registered Prospectively |
| Last Modified On: |
24/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL STUDY OF VASA KSHARASUTRA IN THE MANAGEMENT OF FISTULA-IN-ANO |
|
Scientific Title of Study
|
A CLINICAL EVALUATION OF VASA KSHARASUTRA IN THE MANAGEMENT OF BHAGANDARA (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 WAAPWicramanayake |
| Designation |
MS Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
MS (Ay) First Year Scholar
PG Department Of Shalya Tantra
National Institute Of Ayurveda
Jaipur
Jajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
6375128531 |
| Fax |
|
| Email |
dr.anurawaap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof P Hemantha Kumara |
| Designation |
Professor and Head of the Department |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department Of Shalya Tantra
National Institute Of Ayurveda
Jaipur
Jajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414056362 |
| Fax |
|
| Email |
profphknia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr WAAPWicramanayake |
| Designation |
MS Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
MS (Ay) First Year Scholar
PG Department Of Shalya Tantra
National Institute Of Ayurveda
Jaipur
Jajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
6375128531 |
| Fax |
|
| Email |
dr.anurawaap@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD, National Institute of Ayurveda, Madhav Villas Place, Amer Road, Jaipur |
| Pharmacy, National Institute of Ayurveda, Madhav Villas Place, Amer Road, Jaipur |
|
|
Primary Sponsor
|
| Name |
NAtional Institute of Ayurveda |
| Address |
Madhav Vilas Place,
Jorawar Singh Gate
Amer Road,
Jaipur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anura Wicramanayake |
National Institute of Ayurveda |
Madhav Vilas Place
Jorawar Singh Gate
Amer Road
Jaipur
RAJASTHAN |
6375128531
14126355709
dr.anurawaap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K603||Anal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Apamarga ksharasuthra |
Kshara Suthra will make with Apamarga Kshara with same method and same dose |
| Intervention |
Vasa Kshara Suthra |
Kshara Suthra will make using Vasa Kshara with same method and same dose of apamarga kshara sutra |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female between age 20 to 60 years and willing to give their written
Informed consent.
2. No major systemic disease involved.
3. Patients who have signs and symptoms of Bhagandara (Fistula-in-ano).
|
|
| ExclusionCriteria |
| Details |
Bhagandara (Fistula-in-ano) associated with one or more of the following conditions:-
Ulcerative Colitis
Uncontrolled Hypertension
Uncontrolled Diabetes Mellitus
Veneral diseases
HIV and Hepatitis B patients
Crohn’s disease
Fistula other than ano-rectal area.
All other secondary Fistulae-in-ano.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the Unit Cutting Time (UCT) of the Fistulous Tract |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain, itching and amount of discharge of the Fistulous Tract. |
90 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2019 |
| Date of Study Completion (India) |
19/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Dr. W. A. A. P. Wicramanayake and Prof. P. Hemantha Kumar, VASA KSHARASUTRA IN THE MANAGEMENT OF BHAGANDARA (FISTULA- IN-ANO) -A CASE REPORT, World Journal of Pharmaceutical Research, 2020, 9:7; 1487-1492 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Objectives a. To evaluate the efficacy of Vasa Ká¹£arasutra in the management of Bhagandara(Fistula-in-Ano). b. To compare the efficacy of Vasa Ká¹£arasutra with conventional Apamarga Ká¹£arasutra in the management of Bhagandara(Fistula-in-Ano).
Results and conclusions v Bhagandara (Fistula-in-ano) is a disease which was mentioned since the time of Vedas and Purana. vKsharasutra treatment is the most suitable and effective modality in the treatment of Bhagandara. v Ksharasutra method can be known as a treatment which is safe, effective with minimum or no recurrence. v The people suffering from constipation, Mandagni, having irregular dietary habits, are prone to this disease and the incidence of Bhagandara (Fistula-in-ano) is more in males as compared to females. v The prevalence of Bhagandara is more in the middle age group with who does not have proper hygiene. v Both types of Ksharasutras are cost effective and easily applicable. v Both types were found to be very much effective in reduction of discharge, pain, itching, burning sensation, tenderness and oedema. Inter group compression showed there was no difference between the groups. v Vasa Ksharasutra is having significant less UCT when compared with the Apamarga Ksharasutra. v Both the variety shows less recurrences. v Necrosis, anal incontinence and stenosis were not reported in either group. v Finally we can conclude Vasa Ksharasutra is an alternative for Apamarga Ksharasutra and by comparing UCT can decide it’s having much better action than Apamarga Ksharasutra. |