| CTRI Number |
CTRI/2025/03/082897 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| 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 evaluate efficacy of Patha Tail Pichu In Management Of Parikartika W.S.R. To Acute Fissure In Ano |
|
Scientific Title of Study
|
Randomised controlled clinical trial to evaluate the efficacy of Patha Tail Pichu In Management Of Parikartika W.S.R. To Acute 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 Suyash Ravindra Golde |
| Designation |
PG Scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 |
| Address |
Late Kedari Redekar Ayurvedic
Mahavidyalaya Shalya Department
Gadhinglaj Kolhapur pin 416502
Kolhapur MAHARASHTRA 416502 India |
| Phone |
8975284033 |
| Fax |
|
| Email |
Suyashgolde@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrShailendra Pandurang Savant |
| Designation |
Reader |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 |
| Address |
Late Kedari Redekar Ayurvedic
Mahavidyalaya Shalya Department
Gadhinglaj Kolhapur pin 416502
Kolhapur MAHARASHTRA 416502 India |
| Phone |
9158574943 |
| Fax |
|
| Email |
Shailendrasavant@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
DrShailendra Pandurang Savant |
| Designation |
Reader |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 |
| Address |
Late Kedari Redekar Ayurvedic
Mahavidyalaya Shalya Department
Gadhinglaj Kolhapur pin 416502
MAHARASHTRA 416502 India |
| Phone |
9158574943 |
| Fax |
|
| Email |
Shailendrasavant@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic
Mahavidyalaya Shalya Department
Gadhinglaj Kolhapur pin 416502 |
|
|
Primary Sponsor
|
| Name |
Dr Suyash Ravindra Golde |
| Address |
Late Kedari Redekar Ayurvedic
Mahavidyalaya Shalya Department
Gadhinglaj Kolhapur pin 416502 |
| 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 Suyash Ravindra Golde |
Late Kedari Redekar Dharmadaya Rugnalaya shalyatantra opd ,Gadhinglaj, Kolhapur |
Late Kedari Redekar Ayurvedic
Mahavidyalaya Shalya Department
Gadhinglaj Kolhapur pin 416502 Kolhapur MAHARASHTRA |
8975284033
Suyashgolde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj, kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | picu, पिचु | (Procedure Reference: Sushrut sutrasthan, Procedure details: After cleaning the site a pichu soaked in patha tail will be placed at the site of fissure overnight) (1) Medicine Name: Durvadi tail, Reference: Yogratnakar sadyovranachikitsa, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | picu, पिचु | (Procedure Reference: Sushrut sutrasthan 38/46-47, Procedure details: After cleaning the site a pichu soaked in patha tail will be placed at the site of fissure overinght) (1) Medicine Name: Patha tail, Reference: Sushrut sutrasthan 38/46-47, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Acute fish in ano without sentinal tag. |
|
| ExclusionCriteria |
| Details |
Chronic fissure in ano, suspected malignancies, fissure in ano secondary to ulcerative colitis, crohns disease |
|
|
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 |
| Relief From symptom within seven days |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healing of fissure better than durvadi tail in short duration of time |
7 days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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
|
According to Ayurveda Parikartika is treated by internal palliative medicine and local
therapies like Anuvasanabasti, Picchabasti, Pichu dharana, Tailapooran, lepa, are
given prime importance in management of parikartika.
In allopathy, the conservative management of an acute fissure in ano is pain relief,
soothing ointment and stool softner and surgical managemrnt like Lord’s anal dilation
fissurectomy, Left Lateral Sphincterotomy. This procedure has its own complication
like incontinence which is more horrible than the actual pathology.
Patha is very effective daha shamak, sthambak and shola nashak also patha is
mentioned in ambashtadi gana by acharya Sushrut which has vrana ropak properties
so it helps in reliveing the symptoms and healing of the disease. Hence the concept
of using patha is derived. Patha taila pichu will be used in this study which can be
done by self, and also it is very much cost effective.
As the disease in itself is very disturbing and can be managed conservatively in acute
stage, so more and more study should be conducted for the betterment of the
patient.
Many studies have been conducted on conservative management of Parikartika in
various Ayurved institutes around the country. However they have anecdotal
approach so we decided to evaluate the efficacy of the proposed drug i.e Patha taila
pichu in management of parikartika w.s.r to Fissure in ano.
|