| CTRI Number |
CTRI/2024/06/068891 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| 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 Lignocaine Gel and Trailokya Vijaya Gel in Pain after Anorectal Surgeries |
|
Scientific Title of Study
|
Clinical Comparative Study To Evaluate The Efficacy Of Local Application Of Trailokya
Vijaya Gel And Lignocaine Gel In Postoperative Pain Management In Anorectal Surgeries |
| 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 Tanishka Gupta |
| Designation |
MS Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur,Rajastan |
| Address |
P G Department Of Shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619109881 |
| Fax |
|
| Email |
dr.tanishka1105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanishka Gupta |
| Designation |
MS Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur,Rajastan |
| Address |
P G Department Of Shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India
RAJASTHAN
342037
India |
| Phone |
8619109881 |
| Fax |
|
| Email |
dr.tanishka1105@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Rajesh Kumar Gupta |
| Designation |
Professor and HOD |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur,Rajastan |
| Address |
P G Department Of Shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636520573 |
| Fax |
|
| Email |
guptadrrajeshkumargupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Karwar Jodhpur Rajasthan 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute Of Ayurved Jodhpur,Rajastan |
| Address |
P G Department Of Shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
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 Tanishka Gupta |
Sanjeevani hospital,post graduate institute of ayurveda |
P G Department Of Shalya tantra Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Ayurved University Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN |
8619109881
dr.tanishka1105@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:K629||Disease of anus and rectum, unspecified. Ayurveda Condition: SULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trailokya Vijaya Gel, Reference: Ras Tarangini Tarang 24, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Lignocaine Gel | Application of Lignocaine gel in Postoperative Pain Management in Anorectal surgeries
Dose: 5g
Dosage form: Ointment
Frequency: sos
Route of Administration: Topical
Duration: 4 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Consented individuals
2 Either Sex, Age group between 20 and 99 years
3 Anorectal surgical procedures under local anaesthesia
4 Patients fulfilling diagnostic criteria |
|
| ExclusionCriteria |
| Details |
1 Subjects suffering from severe systemic diseases such as diabetes, hypertension, bronchial
asthma, cardiac disease, renal failure, etc.
2 Chronic alcoholic and chronic smokers
3 Subjects on antidepressant and anti-psychotic drugs
4 Subjects receiving regular medication containing any analgesic drugs.
5 Patients having unexplained severe pain before operation
6 Patients who develop other complications apart from pain in post operative period
7 Patients suffering from HIV, HbsAg, VDRL, and AIDS |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish the efficacy of Trailokya Vijaya gel compared to lignocaine gel to relieve pain after Anorectal Surgeries |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the Anaesthetic effect of Trailokya Vijaya gel |
30 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)
|
30/06/2024 |
| 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="1"
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 fulfilling the inclusion criteria are fit for the study, should be randomly selected: Group A: Lignocaine Gel 2% in 20 patients. Group B: Trailokya Vijaya Gel in 20 patients. Duration of study: 2-4 weeks Follow up: From 2nd week to 4th week after every 7 days.
|