| CTRI Number |
CTRI/2024/07/071049 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Application of Karpura Ghrita ointment and
Jatyadi Ghrita ointment in Wound of Fissure in ano after surgery |
|
Scientific Title of Study
|
Comparative clinical evaluation of Karpura Ghrita ointment and
Jatyadi Ghrita ointment in the management of Postoperative
Wound wsr 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 Arun Bhati |
| Designation |
MS Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur Rajasthan |
| Address |
P G Department Of Shalya tantra Post Graduate Institute of Ayurved
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9414082007 |
| Fax |
|
| Email |
drarunbhati81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Bhati |
| Designation |
MS Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur Rajasthan |
| Address |
P G Department Of Shalya tantra Post Graduate Institute of Ayurved
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9414082007 |
| Fax |
|
| Email |
drarunbhati81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishnu Dutt Sharma |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur Rajasthan |
| Address |
P G Department Of Shalya tantra Post Graduate Institute of Ayurved
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7742042974 |
| Fax |
|
| Email |
ayurvishnu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Karwar Jodhpur Rajasthan 342037 India |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute Of Ayurved Jodhpur Rajasthan |
| Address |
P G Department Of Shalya tantra Post Graduate Institute of Ayurved
Dr Sarvepalli Radhakrishnan Ayurved University
Jodhpur RAJASTHAN 342037 India |
| Type of Sponsor |
Government 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 Arun Bhati |
Sanjeevani hospital Post Graduate Institute of Ayurveda Jodhpur |
P G Department Of
Shalya tantra Post
Graduate Institute of
Ayurved Dr Sarvepalli
Radhakrishnan Ayurved
University Jodhpur
RAJASTHAN 342037
India
Jodhpur
RAJASTHAN |
9414082007
drarunbhati81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post Graduate Institute of Ayurved Jodhpur |
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 | Drug | Classical | | (1) Medicine Name: Jatyadi Ghrita, Reference: Bhaishajya Ratnawali, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(g), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karpura Ghrita, Reference: Bhaishajya Ratnawali, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(g), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with classical signs and symptoms of Vrana after surgical procedure will be
included in the trial |
|
| ExclusionCriteria |
| Details |
1 Patient suffering from any malignancy
2 Patient suffering from tuberculosis
3 Patient suffering from HIV& Hepatitis B
4 Patient suffering from any major uncontrolled systemic disorder viz -HTN, T2DM
etc. will be discarded |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of Karpura ghrit ointment with Jatyadi ghrit ointment in the
management of post operative wound wsr to fissure in ano
|
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Contemporary and comprehensive study of the related problem
To compare the better healing and recovery time of the wound in fissure in ano |
15 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/07/2024 |
| 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="0"
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
|
Number of patients: 40 (20 patients in each) Study type: Interventional (clinical trial), Randomized comparative study 40 Patients full filling the inclusion criteria will be randomly selected for the study. Group A: Karpura Ghrita Ointment local administration-20 Patients Group B: Jatyadi Ghrita Ointment local administration -20 Patients Duration Total 7 days will be needed for each patient for the trial Follow up – 7 Days each Time period - 15 days |