| CTRI Number |
CTRI/2025/03/081517 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Vijaya Herbal Patch for Post-Surgery Pain |
|
Scientific Title of Study
|
Development And Evaluation Of Clinical Efficacy Of Vijaya Patra Transdermal Patch In Post Operative Pain Management
|
| 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 Nikhil Nimba Girase |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved Department of Shalya Tantra 4th floor room no 403 Parul University,Limda.
Vadodara
GUJARAT
391760
India |
| Phone |
7744066499 |
| Fax |
|
| Email |
dr.nikhilgirase06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praikshit Shirode |
| Designation |
professor |
| Affiliation |
parul institute of ayurved |
| Address |
Parul Institute of Ayurved Department of Shalya Tantra 4th floor room no 403 Parul University,Limda,Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9960063588 |
| Fax |
|
| Email |
parikshit.shirode260038@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praikshit Shirode |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved Department of Shalya Tantra 4th floor room no 403 Parul University,Limda,Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9960063588 |
| Fax |
|
| Email |
parikshit.shirode260038@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved Department of Shalya Tantra 4th floor room no 403 Parul University,Limda,391760 ,Vadodara, Gujarat,India |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved Department of Shalya Tantra 4th floor room no 403 Parul University,Limda,Vadodara,Gujrat,India.391760 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nikhil Girase |
Parul institute of ayurved |
parul institute of ayurved department of shalya tantra 4th floor room
no 403 parul university limda vadodara gujarat
Vadodara
GUJARAT |
7744066499
dr.nikhilgirase06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee ,Parul Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R52||Pain, unspecified. Ayurveda Condition: SULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | DICLOFENAC TRANSDERMAL PATCH | Diclofenac transdermal patch will be applied in nearest muscular area near to the Incision site. Total 15 patients will be included in this group. | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: vijaya patra transdermal patch, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: Intervention patches will include 1.0 ± 0.1 mg of Cannabidiol in an MCT(medium chain triglyceride) solvent on 2.0 ± 0.2 g of yellow
adhesive layer covered with aluminum foil total 15 patients will be included in this group |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergone any surgery by Local or spinal anesthesia, complaining of pain, irrespective of their gender & Occupation.
2.Patients who are above 18 years and below 60 years of age.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are regularly taking anti-epileptic, anti-depressant or anti-psychotic drugs & alcohol.
2.Pregnant or breastfeeding mothers.
3.Patients who are taking NSAIDs regularly for other conditions.
4.Patients not giving consent for enrollment in the study.
5.Known allergy to medical cannabis, or patches ingredients, history of severe liver or kidney disease or other serious psychiatric diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative Pain Reduction and sustained analgesic effect of the transdermal patch over time. |
from commencement of pain reduction in between 1 hours, 6 hours ,12 hours ,24 hours postoperatively for 5 days post operative days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the effect on early ambulation and return to daily activities and Assessing ease of use, adherence, and patient preference compared to controlled group medicine |
from commencement of pain reduction in between 1 hours, 6 hours ,12 hours ,24 hours postoperatively for 5 days post operative days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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 Applicable |
| 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
|
Post-operative pain is a significant concern in surgical practice, requiring effective management to enhance recovery and patient comfort. Conventional analgesics, such as opioids and NSAIDs, pose risks of adverse effects and long-term complications. This study aims to evaluate the clinical efficacy and safety of the Vijaya Patra (Cannabis sativa) transdermal patch as an alternative approach for post-operative pain management. The study will assess pain reduction (VAS scale), opioid/NSAID consumption, duration of analgesia, patient satisfaction, and adverse effects over five days post-surgery. Transdermal drug delivery offers advantages such as sustained release, precise dosing, and reduced systemic side effects. The findings will help establish the potential role of cannabis-based transdermal patches in improving post-operative pain management and reducing reliance on conventional analgesics Given the limited clinical evidence on cannabis-based transdermal patches in post-operative settings, this research will contribute valuable insights into their role as a safe and effective analgesic alternative. Hence the need and uniqueness of study. |