| CTRI Number |
CTRI/2025/02/081418 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study To Study the Ropan effect of Panchavalkal Ointment in Parikartika
|
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Evaluate The Ropan Effect Of
Panchavalkal Ointment In Parikartika WSR FISSURECTOMY WOUND |
| 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 Kunal Rajendra Patil |
| Designation |
PG Scholar MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved
Mahavidyalaya, Ghanekhunt Lote, Khed,Ratnagiri MAHARASHTRA
415722
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9067715491 |
| Fax |
|
| Email |
patilkunal2311@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Borase |
| Designation |
HOD & Professor MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved
Mahavidyalaya, Ghanekhunt Lote, Khed,Ratnagiri MAHARASHTRA
415722
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8329008455 |
| Fax |
|
| Email |
dryogeshborase@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Borase |
| Designation |
HOD & Professor MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved
Mahavidyalaya, Ghanekhunt Lote, Khed,Ratnagiri MAHARASHTRA
415722
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8329008455 |
| Fax |
|
| Email |
dryogeshborase@gmail.com |
|
|
Source of Monetary or Material Support
|
| MES Ayurved Mahavidyalaya & attached Parshuram Hospital & Research Center, Ghanekhunt
Lote, Khed, Ratnagiri, Maharashtra, India-415722. |
|
|
Primary Sponsor
|
| Name |
Dr Kunal Rajendra Patil |
| Address |
MES Ayurved Mahavidyalaya & attached Parshuram Hospital & Research Center, Ghanekhunt
Lote, Khed, Ratnagiri, Maharashtra, India-415722. |
| 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 |
| Dr Kunal Rajendra Patil |
MES Parshuram Hospital |
Department of Shalyatantra ,OPD And IPD , Parshuram Hospital, Ghanekhunt Lote,Khed. Ratnagiri MAHARASHTRA
Ratnagiri
MAHARASHTRA |
9067715491
patilkunal2311@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MES Ayurved mahavidyalaya ethics committee |
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 | Comparator Arm (Non Ayurveda) | | - | Betadine Ointment | Providone Iodine ointment Application Twice A Day Locally at wound site for 15 days after Sitz bath | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchavalkal , Reference: Sushruta Sutrasthan , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(mg), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Panchavalkal Ointment Applied Over Post Fissurectomy Wound After Sitz bath Twice a day |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient of Post-Operative Fissurectomy |
|
| ExclusionCriteria |
| Details |
Patient With Immune Compromised Disease
Patient Suffering From Uncontrolled DM
Acute Fissure In Ano
Patients having bleeding disorder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Study the Ropan effect of Panchavalkal Ointment in Parikartika ( Fissurectomy wound )
Changes in Clinical Features of Parikartika |
15 Days Study With follow up on 1 , 5 ,10 ,15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Detail Study about Parikartika According to Ayurvedic aspect
Detail Study of Fissure in Ano According to Modern aspect
Detail Study of Panchavalkal Ointment |
18 months study with 15 days study on each patient with follow up on 1 , 5 , 10 , 15 th day |
|
|
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)
|
10/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Title : Randomized Controlled Clinical Trial To Evaluate The Ropan Effect Of
Panchavalkal Ointment In Parikartika WSR FISSURECTOMY WOUND Null Hypothesis : Panchavalkal Ointment is not effective for ropan in Parikartika WSR
fissurectomy wound healing Alternative Hypothesis : Panchavalkal Ointment is effective for ropan in Parikartika WSR
fissurectomy wound healing Study Design : Simple Randomized Controlled clinical Trial Inclusion Criteria : Male and Female Patient of Age Group 18-65 Yrs. Patient of Post-Operative Fissurectomy Exclusion Criteria : Patient With Immune Compromised Disease Patient Suffering From Uncontrolled DM Acute Fissure In Ano Patients having bleeding disorder Sample size of each group is taken 30 Patients and total of 60 Patients attending OPD and patients from IPD of parent Ayurveda rugnalaya
and camps in the periphery of parent research center and hospital. Treatment Details : Group A - Panchavalkal Ointment For Local Application Softovac Powder
1TSP HS And Sitz bath with warm water BD Group B - Povidone -Iodine Ointment For Local application Softovac Powder
1TSP HS And Sitz bath with warm water BD Treatment schedule for 15 days Assessment days :- 1,5,10,15
th day Result and inference will be drawn on the basis of readings obtained
before and after treatment by using statistical methods.
|