| CTRI Number |
CTRI/2024/03/064691 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Patoladi siddha taila pichu and Lidocaine 2% jelly local application in the treatment of parikartika (fissure-in-ano) |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the efficacy of Patoladi siddha taila pichu in comparison with Lidocaine 2% jelly local application in the management of Parikartika (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 Sanjay Kumar Srivastava |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 |
| Address |
OPD Number 3 and IPD Shalyatantra
Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Maharashtra
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
7668350744 |
| Fax |
|
| Email |
sanjay.sri2008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit A Paliwal |
| Designation |
Professor MS PhD shalyatantra |
| Affiliation |
Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 |
| Address |
OPD Number 3 and IPD Shalyatantra
Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Maharashtra
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8087975264 |
| Fax |
|
| Email |
dramitpaliwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit A Paliwal |
| Designation |
Professor MS PhD Shalyatantra |
| Affiliation |
Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 |
| Address |
OPD Number 3 and IPD Shalyatantra
Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Maharashtra
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8087975264 |
| Fax |
|
| Email |
dramitpaliwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune |
|
|
Primary Sponsor
|
| Name |
Dr Sanjay Kumar Srivastava |
| Address |
Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 |
| 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 Sanjay Kumar Srivastava |
Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 |
OPD No.3 and IPD of shalyatantra
Pune
MAHARASHTRA |
7668350744
sanjay.sri2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC INSTITUTIONAL ETHICS COMMTTTEE PIMPRI PUNE 18 |
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, (2) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patoladi siddha taila pichu, Reference: Sushrut sutrasthan 38/33, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -Patoladi siddha taila pichu twice a day for 15 days | | 2 | Comparator Arm (Non Ayurveda) | | - | Lidocaine 2% Jelly | Frequency - twice a day
Route of administration - local application
Duration - 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having any 3 of following sign and symptoms
Longitudinal Ulcer in anal region with pain during and defecation, Bleeding per rectum, constipation, anal burning sensation, increased anal spasm. |
|
| ExclusionCriteria |
| Details |
Patient on Anticoagulant Drug
Patient with severe anaemia, crohns disease and ulcerative colitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Patoladi siddha taila pichu in management of pain in parikartika |
To assess the efficacy of Patoladi siddha taila pichu in management of pain in parikartika in 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of patoladi siddha taila pichu in management of wound healing process & management of raktasthambhak process & adverse effect in parikartika |
To assess the efficacy of patoladi siddha taila pichu in the management of wound healing process & management of raktasthambhak process & adverse effect in parikartika in 15 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)
|
19/04/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A randomized controlled clinical trial to evaluate the efficacy of Patoladi Siddha Taila Pichu in comparison with Lidocaine 2% jelly local application in the management of Parikartika ( Fissure - in - Ano). To study the efficacy of patoladi siddh taila in management of parikartika and also to study the adverse effect of patoladi siddha taila . The local application of patoladi siddha taila will be done for 15 days and assesment will be done before treatment and on 5th ,10th and 15th day. Final conclusion will be drawn on the basis of statistical data. |