| CTRI Number |
CTRI/2021/02/031113 [Registered on: 09/02/2021] Trial Registered Prospectively |
| Last Modified On: |
24/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare the effect of two varieties of alkali thread (Pongamia pinnata and Plumbago zylenica ) in fistula. |
|
Scientific Title of Study
|
An open label double arm study on the effect of karanja kshara sutra and chitraka kshara sutra in bhagandara vis a vis Fistula-in-ano. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj D C |
| Designation |
PG scholar |
| Affiliation |
Sri kalabyraveshwara swamy ayurvedic medical college hospital and research center |
| Address |
Department of PG studies in Shalya Tantra,
Sri kalabyraveshwara swamy ayurvedic medical college hospital and research center no 10, pipeline road, RPC layout, vijaynagar second stage, Bengaluru
Sri kalabyraveshwara swamy ayurvedic medical college hospital and research center no 10, pipeline road, RPC layout, vijaynagar second stage, Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
8050943402 |
| Fax |
|
| Email |
manoj.dc39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S V Shailaja |
| Designation |
Professor and HOD |
| Affiliation |
Sri kalabyraveshwara ayurvedic medical college hospital and research center |
| Address |
Department of PG studies in Shalya Tantra,
Sri kalabyraveshwara swamy ayurvedic medical college hospital and research center no 10, pipeline road, RPC layout, vijaynagar second stage, Bengaluru
Sri kalabyraveshwara swamy ayurvedic medical college hospital and research center no 10, pipeline road, RPC layout, vijaynagar second stage, Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
9880917253 |
| Fax |
|
| Email |
shailajaramkumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S V Shailaja |
| Designation |
Professor and HOD |
| Affiliation |
Sri kalabyraveshwara ayurvedic medical college hospital and research center |
| Address |
Department of PG studies in Shalya Tantra,
Sri kalabyraveshwara swamy ayurvedic medical college hospital and research center no 10, pipeline road, RPC layout, vijaynagar second stage, Bengaluru
Sri kalabyraveshwara swamy ayurvedic medical college hospital and research center no 10, pipeline road, RPC layout, vijaynagar second stage, Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
9880917253 |
| Fax |
|
| Email |
shailajaramkumar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Self sponsored
Dr Manoj DC,
Department of PG studies in Shalya Tantra,
Sri kalabyraveshwara swamy ayurvedic medical college hospital and research center no 10, pipeline road, RPC layout, vijaynagar second stage, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr Manoj D C |
| Address |
Sri kalabyraveshwara swamy ayurvedic medical college hospital and research center no 10 pipeline road RPC layout vijaynagar second stage Bengaluru |
| Type of Sponsor |
Other [Self sponsored] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kiran M Goud |
Sri kalabyraveshwara swamy ayurvedic medical college hospital and research center |
Department of PG studies in Shalya Tantra.
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCH &RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K605||Anorectal fistula. Ayurveda Condition: Bhagandhara, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chitraka kshara sutra |
Chitraka kshara sutra to Fistulous tract, Duration depends on the length of Fistulous tract. |
| Intervention |
Karanja kshara sutra |
Karanja kshara sutra to Fistulous tract, Duration depends on the length of Fistulous tract. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with parisravi suitable for kshara sutra karma
Subjects with low anal fistula
|
|
| ExclusionCriteria |
| Details |
Subjects having bhagandara with any systemic disease interfering with the course of treatment
Subjects having bhagandara with more than 2 openings in perianal region |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of effect of karanja kshara sutra and chitraka kshara sutra |
Before Treatment- Day 1.
After treatment- After complete cutting of the tract.
At followup- 7 Days after complete cutting of the tract. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
18/02/2021 |
| 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="2"
Months="1"
Days="27" |
|
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
|
Bhagandara is told as mahagada due to its grave nature in sushruth samhitha pidaka formed at bhagaguda and basti pradesha undergoes suppuration burst open and makes an opening externally known as bhagandara bhagandara described in classics represents fistula in ano with overall prevalence of about 9 cases per 1 lakh population per year fistulotomy and fistulectomy have prolonged hospitalization and infection and incontinence in order to avoid these problems kshara sutra ligation which is explained in management of nadi vrana can be adopted in bhagandara as well Karanja and chitraka are mentioned as dravyas for kshara preparation so a study of the same as take up and the results will be analyzed |