| CTRI Number |
CTRI/2024/08/072574 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study between Talisadi Taila and Jatyadi Taila ointment in Parikartika |
|
Scientific Title of Study
|
A Comparative Clinical Efficacy of Talisadi Taila Ointment and Jatyadi Taila
Ointment in the Management of Parikartika w.s.r. Acute Fissure-in-Ano |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| - |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Snehal Patil |
| Designation |
Assistant Professor |
| Affiliation |
G.J.Patel Institute Of Ayurvedic Studies and Research New V.V. Nagar, Anand, Gujarat |
| Address |
G J Patel Institute Of Ayurvedic Studies and Research New V.V.Nagar Anand, Gujarat
Department Of Shalyatantra
Room no 403
Department Of Shalyatantra
Room NO 403
Anand
GUJARAT
388120
India |
| Phone |
9028822793 |
| Fax |
|
| Email |
patilsnehal2222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipsinh Chavda |
| Designation |
Professor |
| Affiliation |
G.J.Patel Institute Of Ayurvedic Studies and Research New V.V. Nagar, Anand, Gujarat |
| Address |
G J Patel Institute Of Ayurvedic Studies and Research New V.V.Nagar Anand, Gujarat
Department Of Shalyatantra Room No 402
Department Of Shalyatantra
Room No 402
Anand
GUJARAT
388120
India |
| Phone |
9028822793 |
| Fax |
|
| Email |
dispinh.chavda@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Patil |
| Designation |
Assistant Professor |
| Affiliation |
G.J.Patel Institute Of Ayurvedic Studies and Research New V.V. Nagar, Anand, Gujarat |
| Address |
G J Patel Institute Of Ayurvedic Studies and Research New V.V.Nagar Anand, Gujarat
Department Of Shalyatantra
Room No 403
Department Of Shalyatantra
Room NO 403
Anand
GUJARAT
388120
India |
| Phone |
9028822793 |
| Fax |
|
| Email |
patilsnehal2222@gmail.com |
|
|
Source of Monetary or Material Support
|
| S G Patel Hospital and Maternity Home New V.V. Nagar Anand 388120 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Dr Snehal Patil |
| Address |
G J Patel Institute Of Ayurvedic Studies and Research new v.v Nagar Anand
Department Of Shalyatantra |
| 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 Snehal Patil |
S G Patel Ayurveda Hospital and maternity home |
OPD NO 25 Shalyatantra,
New v v nagar Anand 388120
Anand
GUJARAT |
9028822793
patilsnehal2222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GJPatel Institute of Ayurvedic Studies and Research and S.G.Patel Ayurveda Hospital and Maternity Home |
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 | Drug | Classical | | (1) Medicine Name: Jatyadi Taila, Reference: Sharangadhara Madhyam Khanda 9/168-172, Route: Rectal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Talisadi Taila, Reference: Sushruta Chikitsa 2/75, Route: Rectal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 60
Patient with controlled diabetes mellitus.
Anal fissure without any associated ano-rectal disorder
|
|
| ExclusionCriteria |
| Details |
Fissure with external or internal tag
K/C/O comorbid conditions with Hypertension, Diabetes Mellitus, Chron’s
Disease, Ulcerative Colitis, Anal Cancer, Tuberculosis, HIV Reactive, HBsAg
Reactive, STD, Psychosomatic Disorders, Portal hypertension or Liver disorder.
Pregnant lady and Lactating Mother |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
pain and burning relief
healing of fissure-in-Ano |
healing of fissure-in-Ano in 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete healing of fissure-in-Ano |
15 days |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| 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="5"
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
|
Now-a-days ointments which are used in fissure-in-Ano are easily available in the market but there is no long lasting effect which postponed surgical intervention. It required look forward to The Ayurvedic ointment preparation which is feasible in current lifestyle which will gives significant result for healing. Hence both drugs are selected for studying the effect of ointment form in the management of Parikartika w.s.r to Acute Fissure-in-Ano. |