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CTRI Number  CTRI/2024/08/073026 [Registered on: 28/08/2024] Trial Registered Prospectively
Last Modified On: 22/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Herbal Formulation ]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study on the management of migraines using oral and topical formulations.  
Scientific Title of Study   Impact of comprehensive oral and topical intervention on MIDAS scores, frontalis muscle activity, and dependence on rescue medication in migraine patients without aura: a randomized placebo-controlled study.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/008 Version: 1.00; Dated, 21st May 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramshyam Agarwal 
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  OPD Room No. 401, 4th-floor, 314 B Telco Road Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  8087282022  
Fax  -  
Email  ramshyam.research@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Raghav Priyadarshi 
Designation  CEO 
Affiliation  Savikalpa Sciences Pvt. Ltd. 
Address  A1/6 Panchsheel Enclave, 2nd Floor

New Delhi
DELHI
110017
India 
Phone  99991691165  
Fax  -  
Email  raghav@savikalpa.com  
 
Details of Contact Person
Public Query
 
Name  Kshitij Bal 
Designation  COO 
Affiliation  Savikalpa Sciences Pvt. Ltd. 
Address  B-40, 1st Floor, Soami Nagar South,

New Delhi
DELHI
110017
India 
Phone  9899862662  
Fax  -  
Email  kshitij@savikalpa.com  
 
Source of Monetary or Material Support  
Savikalpa Sciences Pvt. Ltd.; A1/6, Panchsheel Enclave, New Delhi - 110017. (Promoter Funds) 
 
Primary Sponsor  
Name  Savikalpa Sciences Pvt. Ltd. 
Address  A1/6, Panchsheel Enclave, New Delhi - 110017. 
Type of Sponsor  Other [Manufacturer of cannabis medicine ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramshyam Agarwal   Lokmanya Medical Research Centre and Hospital  OPD 401, 4th-floor, 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 
8087282022
-
ramshyam.research@gmail.com 
Dr Ketan Kshirsagar  Sangvi Multispeciality Hospital Pvt. Ltd.  Sr. No. 71/1/2/189, City Survey No.2387, Krushna Chowk, Krushna Nagar, New Sangvi, Pune-411027, Maharashtra, India
Pune
MAHARASHTRA 
9049002749
-
drketan.sangvihospital@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee of Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Sangvi Multispeciality Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G430||Migraine without aura,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A: Oral formulation (edible oil)  Mode of Administration: - Participants should take four (4) drops of the oral medication twice daily (BID) after breakfast and dinner. - Participants may increase dosage by one (1) drop every two weeks. - Maximum dosage not to exceed eight (8) drops per dose and sixteen (16) drops per day. - Edible oil to be simply ingested (no need for sublingual dosage)  
Intervention  Group B: Topical formulation (roll-on)  Mode of Administration: - Participants to apply the roll-on topical formulation to their temples, forehead and below ears/jawline only if there is onset of an attack when the participant feels/can sense an imminent attack coming. - Medication should be administered on an as-needed (SOS) basis rather than through daily dosing. - Application to be repeated as needed, up to six times daily.  
Intervention  Group C: Oral + Topical formulation (edible oil +roll on)  Oral formulation (edible oil): Mode of Administration: - Participants should take four (4) drops of the oral medication twice daily (BID) after breakfast and dinner. - Participants may increase dosage by one (1) drop every two weeks. - Maximum dosage not to exceed eight (8) drops per dose and sixteen (16) drops per day. - Edible oil to be simply ingested (no need for sublingual dosage) Topical formulation (roll-on): Mode of Administration: - Participants to apply the roll-on topical formulation to their temples, forehead and below ears/jawline only if there is onset of an attack when the participant feels/can sense an imminent attack coming. - Medication should be administered on an as-needed (SOS) basis rather than through daily dosing. - Application to be repeated as needed, up to six times daily.  
Comparator Agent  Group D: Oral Placebo formulation  Mode of Administration: - Participants should take four (4) drops of the oral placebo medication twice daily (BID) after breakfast and dinner. - Participants may increase dosage by one (1) drop every two weeks. - Maximum dosage not to exceed eight (8) drops per dose. - Edible oil to be simply ingested (no need for sublingual dosage)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Both 
Details  Participants meeting all the following criteria will be eligible for the study: 1. Male and females, between 18 to 49 years of age (both inclusive); 2. Participants with a headache history for more than 1 year, 5 or more attacks of headache in 3 months; 3. Willingness to take the investigational product, following the dietary restrictions for the duration of the study; 4. Willing to complete the migraine diary.

 
 
ExclusionCriteria 
Details  Participants meeting any of the following criteria will not be eligible for the study: 1. Participant with primary psychiatric disorders (schizophrenia, depression, anxiety, psychosis), major medical illness like renal, hepatic, neurological and cardiac diseases, pure menstrual migraine 2. Participants on Ayurveda or Yoga intervention for the past 6 months 3. Participants on conventional prophylactic treatment were excluded from the study
4. Known history of hypersensitivity to investigational product or its component 5. Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test; 6. Any condition that in the opinion of the investigator does not justify the trial participant’s inclusion in the study.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary endpoints of the study will be to calculate and assess:
1. Changes in MIDAS (Migraine Disability Assessment) scale score using migraine diary
2. Changes in Human Plasma Calcitonin Gene Related Peptide (CGRP) levels
For 40 patients before and after treatment (10 subjects in each group)

 
1. at screening, day 30, 60 and 90.
2. at screening and day 90. 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary endpoints of the study will be to assess: 1. Assessment of change in the requirement of rescue medication (Abortive migraine medications) 2. Changes in the number of headaches (No. of events) events and intensity (on 0-10 VAS) using migraine diary 3. Assessment of changes in Migraine Specific Quality of Life Questionnaire (MSQ) score

 
1. at baseline, day 15, 30, 45, 60, 75 and 90.
2. at day 15, 45, and 75.
3. at baseline and day 90.  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   06/09/2024 
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="0"
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  

Migraine, a prevalent and debilitating neurological condition, significantly impairs quality of life and functional capacity. Current pharmacological treatments side effect profile underscore the need for novel therapeutic interventions that are both effective and better tolerated.

Cannabis (Vijaya extract) has been proposed as a potential therapeutic agent for migraine due to its analgesic, anti-inflammatory, and anti-emetic properties. Both oral and topical formulations of cannabis may offer a novel approach to managing migraine symptoms. The rationale for this study is based on the hypothesis that cannabis can effectively reduce migraine frequency, severity, and associated disability without the adverse effects commonly seen with conventional treatments.

This study aims to provide scientific evidence on the efficacy and safety of cannabis (Vijaya extract) in treating migraine without aura. By comparing the impact of oral, topical, combined and placebo formulations this research seeks to identify optimal therapeutic strategies that offer rapid and consistent relief, restore patient functionality, and minimize adverse effects. The outcomes could lead to the development of new, effective, and well-tolerated treatments for migraine, improving the quality of life for patients and reducing the burden on healthcare systems and burden of disease overall due to improved ability to work / increased workplace productivity.

 
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