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CTRI Number  CTRI/2026/04/108727 [Registered on: 20/04/2026] Trial Registered Prospectively
Last Modified On: 14/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of cannabryl oil in head,neck and shoulder regions. 
Scientific Title of Study   Effect of topical application of Cannabryl oil at innervation zones for myofascial pain in head neck and shoulder regions 
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 Nimisha Verma  
Designation  Professor  
Affiliation  IMS , BHU 
Address  Department of Anaesthesiology IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  919559955988  
Fax    
Email  verma.nimisha5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nimisha Verma  
Designation  Professor  
Affiliation  IMS , BHU 
Address  Department of Anaesthesiology IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  919559955988  
Fax    
Email  verma.nimisha5@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nimisha Verma  
Designation  Professor  
Affiliation  IMS , BHU 
Address  Department of Anaesthesiology IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  919559955988  
Fax    
Email  verma.nimisha5@gmail.com  
 
Source of Monetary or Material Support  
INDOGENIX BIOSCIENCES LLP, PLOT-A2,BAGRODA INDUSTRIAL AREA, BHOPAL, MADHYA PRADESH, 462026  
 
Primary Sponsor  
Name  INDOGENIX BIOSCIENCES LLP 
Address  PLOT-A2,BAGRODA INDUSTRIAL AREA, BHOPAL, MADHYA PRADESH, 462026  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sai Vamsi   IMS, BHU  Department of Anaesthesiology,
Varanasi
UTTAR PRADESH 		 9618540054

saivamsim98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE VARANASI   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Myofascial pain of head , neck and shoulder. 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Cannabryl oil , Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 0.5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: THC free cannabidiol extract from hemp plant.
2Comparator Arm (Non Ayurveda)-Diclofenac gel General NSAID used for chronic pain.
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients with chronic pain more than 3 months in only single region will be taken.
2.Patients diagnosed with electromyography having trigger zone areas.
3.Patients with chronic pain but unresponsive to conservative medications.
4. Patients who gave willing consent for trial. 
 
ExclusionCriteria 
Details  1.Patients with pain in more than one region.
2.Patients who are allergic to CBD oil.
3.Patients having infections at the pain region.
4.Patients with history of abuse of cannabis.
5.Patients with sever psychiatric illness.
6.Patients who refuse to participate.
7.Patients having cardiac issues.
8.Pregnancy and lactating women.
9.Drug abuse or addictions. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the topical application of cannabryl oil in myofascial pain of head neck and shoulder regions at nerve innervation zones along with any side effects and efficacy.  Base line- pain assessed
2 weeks - pain relief and side effects.
4 weeks - pain relief and side effects.
8 weeks - pain relief and side effects. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To see for allergic reactions.
2. To see any systemic side effects from usage of cannabryl oil. 		 1. Allergic reactions -15 days
2. Systemic side effects -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 
Date of First Enrollment (India)   25/04/2026 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [saivamsim98@gmail.com].

  6. For how long will this data be available start date provided 27-03-2026 and end date provided 27-03-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   To see effective of cannabryl oil in myofascial pain in head neck and shoulder regions in two groups of patients using cannabryl oil and traditional diclofenac gel.and asses the non inferiority of cannabryl oil to diclofenac gel. And to study for any side effects of the cannabryl oil.
Group A- 1-20 numbers will receive cannabryl oil.
Group B- 20-40 numbers will receive diclofenac gel.
 
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