| CTRI Number |
CTRI/2020/10/028559 [Registered on: 22/10/2020] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparative study of medicated ksharasutra with traditional kshara sutra in fistula in ano |
|
Scientific Title of Study
|
Comparative Efficacy Study of New Medicated Ksharsutra with Conventional Ksharsutra in management of 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 |
Rushikesh Thakre |
| Designation |
lecturer |
| Affiliation |
MGACH & RC DMIMS(DU) Wardha(MS) |
| Address |
Room no.13,Shalya tantra Department ,MGACH & RC DMIMS(DU) Wardha(MS)
Wardha
MAHARASHTRA
442001
India |
| Phone |
09765404039 |
| Fax |
|
| Email |
dr.rushu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rushikesh Thakre |
| Designation |
lecturer |
| Affiliation |
MGACH & RC DMIMS(DU) Wardha(MS) |
| Address |
Room no.13,Shalya tantra Department ,MGACH & RC DMIMS(DU) Wardha(MS)
Wardha
MAHARASHTRA
442001
India |
| Phone |
09765404039 |
| Fax |
|
| Email |
dr.rushu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rushikesh Thakre |
| Designation |
lecturer |
| Affiliation |
MGACH & RC DMIMS(DU) Wardha(MS) |
| Address |
Room no.13,Shalya tantra Department ,MGACH & RC DMIMS(DU) Wardha(MS)
Wardha
MAHARASHTRA
442001
India |
| Phone |
09765404039 |
| Fax |
|
| Email |
dr.rushu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma gandhi ayurved college hospital and research centre |
|
|
Primary Sponsor
|
| Name |
Datta meghe institute of medical sciences |
| Address |
sawangi meghe wardha |
| 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 |
| Rushikesh thakre |
Mahatma Gandhi Ayurved College Hospital & research centre salod wardha |
Room no.13,Shalya tantra department
Wardha
MAHARASHTRA |
9765404039
dr.rushu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta meghe institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K605||Anorectal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional kshar sutra |
kshara sutra will be changed every 7 days |
| Intervention |
medicated kshar sutra |
conventional kshar sutra |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing with consent,
2.Patient irrespective of sex, occupation and economic status will be included.
|
|
| ExclusionCriteria |
| Details |
1. H/O anorectal surgery.
2. Infected fistula
3. Pregnancy
4. Metabolic diseases
5. Systemic chronic devaluating diseases
6. Immuno compromised patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the symptoms of fistula in ano |
0,7,14,28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the symptoms of fistula in ano |
60th day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
26/10/2020 |
| 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
Modification(s)
|
done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- To assess the efficacy of a new medicated ksharsutra
in promotion of healing in fistula- in- ano.
- To
assess the efficacy of conventional Ksharsutra in promotion of healing in
fistula- in- ano.
- To
compare the efficacy of new medicated Ksharsutra and conventional Ksharsutra in promotion of healing in fistula- in- ano.
|