| CTRI Number |
CTRI/2024/11/076835 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To See The Effect Of Udumbara Sidhha Taila Matrabasti In Management Of Parikartika With Reference To Fissure In Ano |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study Of Efficacy Of Udumbara Siddha Taila Matra Basti In Management Of Parikartika W S R To Fissure 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 Niteen Ganpat Harimkar |
| Designation |
MS Shalyatantra Scholar |
| Affiliation |
Dr.VJD Gramin Ayurved Mahavidyala Patur |
| Address |
Dr VJD Gramin Ayurved Mahavidyala near Renuka Mata mandir Patur Tal-Patur Dist-Akola State-Maharashtra Country-India
Akola
MAHARASHTRA
444501
India |
| Phone |
88698878264 |
| Fax |
|
| Email |
niteenharimkar173@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Mawale |
| Designation |
Professor and Head of the Department,Shalyatantra |
| Affiliation |
Dr.VJD Gramin Ayurved Mahavidyala,Patur |
| Address |
OPD NO 18 Department of Shalyatantra Dr.VJD Gramin Ayurved Mahavidyala,near Renuka Mata mandir,Patur,Tal-Patur,Dist-Akola
Akola
MAHARASHTRA
444501
India |
| Phone |
9850500860 |
| Fax |
|
| Email |
gayatriakola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Mawale |
| Designation |
Professor and Head of the Department,Shalyatantra |
| Affiliation |
Dr.VJD Gramin Ayurved Mahavidyala,Patur |
| Address |
OPD NO 18 Department of Shalyatantra Dr.VJD Gramin Ayurved Mahavidyala,near Renuka Mata mandir,Patur,Tal-Patur,Dist-Akola
Akola
MAHARASHTRA
444501
India |
| Phone |
9850500860 |
| Fax |
|
| Email |
gayatriakola@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of shalyatantra ,Mahavidyala,Patur,Tal-Patur,Dist-Akola, Maharashtra 444501 |
|
|
Primary Sponsor
|
| Name |
Dr.VJD Gramin Ayurved Mahavidyala,patur |
| Address |
Dr.VJD Gramin Ayurved Mahavidyala,Near Renuka Mata mandir,Patur,Tal-Patur,Dist-Akola, Maharashtra 444501 |
| Type of Sponsor |
Private medical college |
|
|
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 Niteen Ganpat Harimkar |
Dr VJD Gramin Ayurveda Mahavidyala Patur |
OPD no 18 Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyala near Renuka Mata mandir Patur Tal-Patur Dist-Akola State-Maharashtra
Akola
MAHARASHTRA |
8698878264
niteenharimkar173@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr VJD Gramin ayurved mahavidyalaya Patur Akola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Matrabasti | (Procedure Reference: Sushrut Samhita, Procedure details: The anal site will be cleaned with betadine.
20ml Udumbara siddha taila will be taken in the syringe, sterile rubber catheter number
8 will be attached to the syringe Rubber catheter will be inserted into anus and
Udumbara siddha taila will be pushed slowly.
Udumbara siddha taila matrabasti will be done
All other precautions and instructions for avoiding infection will be given to patient.)
(1) Medicine Name: Udumbara Siddha taila, Reference: Sushrut Samhita, Route: Rectal, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 10 Days | | 2 | Comparator Arm | Procedure | - | Matrabasti | (Procedure Reference: Sushrut Samhita , Procedure details: The anal site will be cleaned with betadine.
20ml Udumbara siddha taila will be taken in the syringe, sterile rubber catheter number
8 will be attached to the syringe, Rubber catheter will be inserted into anus and
Udumbara siddha taila will be pushed slowly.
Udumbara siddha taila matrabasti will be done All other precautions and instructions for avoiding infection will be given to patient.)
(1) Medicine Name: Jatyadi taila, Reference: Sushrut Samhita, Route: Rectal, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient willing to participate in study
.
2) Patients will be selected irrespective of sex, marital status, religion, educational and
economical status.
3) Patients having acute and Chronic Fissure in ano symptoms like pain , ulcer.
4) Patients with Controlled diabetes mellitus.
5) Co-operative patients. |
|
| ExclusionCriteria |
| Details |
1) Patients not willing to participate in the study.
2) Patients of Fissure in ano associated with Haemorrhoids, Fistula in ano or other ano-
rectal conditions.
3) Patient’s with any major systemic illness i.e.TB and CA.
4) Non co-operative Patient.
5) Patients with uncontrolled diabetes mellitus.
6) Diagnosed case of HBsAg and HIV positive patients.
7) Diagnosed case of crohn’s disease.
8) Bleeding disorders.
9) Severe anaemia.
10) ANC women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Burning pain during defecation
2)Bleeding
3)Pruritis
4)Malavshthmbha |
3,6,10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in all the Symptoms of Parikartika |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Not yet recruiting |