| CTRI Number |
CTRI/2021/02/031449 [Registered on: 22/02/2021] Trial Registered Prospectively |
| Last Modified On: |
20/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO STUDY THE ROLE OF HONEY BASED KSHAR SUTRA IN THE MANAGEMENT OF BHAGANDAR WSR FISTULA IN ANO |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF HONEY BASED KSHAR SUTRA AND SNUHIKSHEER BASED KSHAR SUTRA IN THE MANAGEMENT OF BHAGANDAR W.S.R TO 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 |
KALPANA ROHTELA |
| Designation |
MS PG SCHOLAR |
| Affiliation |
BHARATI AYURVED COLLEGE AND HOSPITAL |
| Address |
BHARATI AYURVED HOSPITAL
DEPARTMENT OF SHALYA TANTRA
OPD NO. 3
GROUND FLOOR
DHANKAWADI
KATRAJ
PUNE
BHARATI AYURVED HOSPITAL
DEPARTMENT OF SHALYA TANTRA
OPD NO 3
GROUND FLOOR
DHANKAWADI
KATRAJ
PUNE
Pune
MAHARASHTRA
411043
India |
| Phone |
9899211034 |
| Fax |
|
| Email |
kalpananovrohtela@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BHARAT ROKADE |
| Designation |
Associate professor |
| Affiliation |
BHARATI AYURVED COLLEGE AND HOSPITAL |
| Address |
BHARATI AYURVED HOSPITAL
DEPARTMENT OF SHALYA TANTRA
OPD NO 3
GROUND FLOOR
DHANKAWADI
KATRAJ
PUNE
BHARATI AYURVED HOSPITAL
DEPARTMENT OF SHALYA TANTRA
OPD NO 3
GROUND FLOOR
DHANKAWADI
KATRAJ
PUNE
Pune
MAHARASHTRA
411043
India |
| Phone |
9822552223 |
| Fax |
|
| Email |
bharatrokade20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KALPANA ROHTELA |
| Designation |
MS PG SCHOLAR |
| Affiliation |
BHARATI AYURVED COLLEGE AND HOSPITAL |
| Address |
BHARATI AYURVED HOSPITAL
DEPARTMENT OF SHALYA TANTRA
OPD NO 3
GROUND FLOOR
DHANKAWADI
KATRAJ
PUNE
BHARATI AYURVED HOSPITAL
DEPARTMENT OF SHALYA TANTRA
OPD NO 3
GROUND FLOOR
DHANKAWADI
KATRAJ
PUNE
Pune
MAHARASHTRA
411043
India |
| Phone |
9899211034 |
| Fax |
|
| Email |
kalpananovrohtela@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati ayurved college and hospital,pune |
|
|
Primary Sponsor
|
| Name |
KALPANA ROHTELA |
| Address |
BHARATI AYURVED HOSPITAL
DHANKAWADI
KATRAJ
PUNE |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| KALPANA ROHTELA |
BHARATI AYURVED HOSPITAL |
DEPARTMENT OF SHALYA TANTRA
OPD NO 3
DHANKAWADI
KATRAJ
PUNE
Pune
MAHARASHTRA |
9899211034
kalpananovrohtela@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: BHAGANDAR , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Honey based kshar sutra will be applied to one group and another group will be having snuhiksheer based kshar Sutra |
Instead of snuhiksheer base. Trying to find out the alternative to it. So honey will be used. Then coating of haridra and sonmarga kshar will be applied. |
| Comparator Agent |
One group will be used with honey based kshar Sutra and another group will be given snuhiksheer based kshar Sutra |
Snuhiksheer based kshar Sutra will be prepared by applying the snuhiksheer Om barbers linen thread and then coatings of haridra and apamarga kshar will be applied |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients having fistula will be randomly selected. selection shall be irrespective of sex, religion and socio economic status.age between 15 to 60 years. |
|
| ExclusionCriteria |
| Details |
pregnancy
patients below age 15 and above age 60 years
previously diagnosed ca rectum, chronic and ulcerative colitis
veneral disease
multiple fistulae due to tuberculosis |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HONEY BASED KSHAR SUTRA IS AS EFFECTIVE AS THE SNUHIKSHEER BASED KSHAR SUTRA IN THE MANAGEMENT OF BHAGANDAR W.S.R. FISTULA IN ANO |
TIME PERIOD WILL DEPEND ONTHE LENGTH OF THE TRACT AND UNIT CUTTING TIME AND MAXIMUM 8 WEEKS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HONEY BASED KSHAR SUTRA IS EFFECTIVE IN THE MANAGEMENT OF BHAGANDAR WSR FISTULA IN ANO. |
TIME PERIOD WILL DEPEND ON THE LENGTH OF THE TRACT AND UNIT CUTTING TIME AND MAXIMUM 8 WEEKS. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/02/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparative study of honey based kshar sutra and snuhiksheer based kshar Sutra. Total 40patients will be taken.20 in each group. Honey based kshar Sutra will be applied in one group and another group will have snuhiksheer based kshar Sutra. 1st day will be screening and investigation will be done. Next day will be posted for surgery. Follow up will be every 7th day after kshar Sutra ligation. Accordingly unit cutting time and length of the tract will be recorded. |