| 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
|
|
|
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
|
|
|
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. |