| CTRI Number |
CTRI/2022/05/042626 [Registered on: 18/05/2022] Trial Registered Prospectively |
| Last Modified On: |
18/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study on MIGRA365 Capsule in Migraine |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled, multi-center, comparative, interventional, prospective clinical study to evaluate efficacy and safety of MIGRA365 Capsule in Participants Suffering from Episodic Migraine |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MIGRA/TLS/2022/01, Version 1.0, 15th March 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shripad Kore |
| Designation |
Consultant Physician |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Ayurved Hospital-Sane Guruji Arogya Kendra |
| Address |
Department of Kayachikitsa, Special OPD No. 2, 2nd floor, MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Ayurved Hospital-Sane Guruji Arogya Kendra, Malwadi Hadapsar, Pune-28
Pune
MAHARASHTRA
411028
India |
| Phone |
8999076147 |
| Fax |
|
| Email |
dkshripad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd. Fourth Floor,
A Wing 402- A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd. Fourth Floor,
A Wing 402- A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Transformative Learning Solutions Private Limited
1 G, Bharat Nagar, New Friends Colony,
New Delhi-110025 |
|
|
Primary Sponsor
|
| Name |
Transformative Learning Solutions Private Limited |
| Address |
1 G, Bharat Nagar, New Friends Colony, New Delhi-110025
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandhya Rani D |
JSS Ayurveda Medical College and Hospital |
Department of Shalakyatantra, OPD No 4, Ground Floor, JSS Ayurveda Medical College and Hospital, Lalitharipura Road, Allanahalli, Mysore, Karnataka- 570028
Mysore
KARNATAKA |
9448584801
sandhyaranid30@yahoo.in |
| Dr Vaishali Deshpande |
Khemdas Ayurved Hospital |
Department of Kayachikitsa, Ground Floor, OPD No. 8, Khemdas Ayurved Hospital,P.O. Ishwarpura, Tal-Waghodia, Dist-Vadodara
Vadodara
GUJARAT |
9096082950
dr.vaishalid@gmail.com |
| Dr Shripad Kore |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya and AYurved Hospital-Sane Guruji Arogya Kendra |
Department of Kayachikitsa, Special OPD No. 2,
2nd floor, MAMs Sumatibhai Shah Ayurved Mahavidyalaya and AYurved Hospital-Sane Guruji Arogya Kendra, Malwadi Hadapsar, Pune-28
Pune
MAHARASHTRA |
8999076147
dkshripad@gmail.com |
| Dr Shailesh Deshpande |
Parul Ayurveda Hospital, Parul University |
Department of Kayachikitsa, OPD no 106, Ground Floor, Parul Ayurveda Hospital, Parul University, P.O. Limba, Tal. Wagholia, Dist. Vadodara, Gujrat 391760
Vadodara
GUJARAT |
9763104451
dr.shaileshd@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee-JSS Ayurveda Medical College |
Approved |
| Institutional Ethics Committe, Khemdas Ayurveda Hospital, Parul Institute of Ayurved and Research, Vadodara |
Approved |
| Institutional Ethics Committee, Parul Ayurveda Hospital, Parul University |
Approved |
| Institutional Ethics Committee, PIAR IECHR |
Approved |
| MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Ayurved Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: MIGRA365 Capsule , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Subjects will be asked to take given product (MIGRA365 capsule or matching placebo) in a dose of 1 capsule twice daily orally after meals with water for 3 months. | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo Capsule | Subjects will be asked to take given product (MIGRA365 capsule or matching placebo) in a dose of 1 capsule twice daily orally after meals with water for 3 months. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
1. Literate male and female, in otherwise good health condition,
2. History of migraine headache disorder meeting International Classification of Headache Disorders ICHD 3 diagnostic criteria for migraine with aura or migraine without aura for greater than 12 months.
3. Subjects willing to sign informed consent and to undergo all the study procedure
|
|
| ExclusionCriteria |
| Details |
1. Current diagnosis of chronic migraine according to ICHD-3
2. History or current diagnosis of migraine with, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache.
3. History of headache attributed to another disorder (e.g., secondary headaches)
4. Subjects with any other investigational products within 1 month prior to randomization;
5. Subjects with uncontrolled diabetes mellitus and hypertension
6. Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure.
7. Pregnant and lactating women
8. Subjects with significant abnormal laboratory parameters as per the investigator
9. Known hypersensitivity to any of the ingredients of MIGRA365 Capsule
10. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative difference in number of monthly migraine days. |
Screening Visit (up to Day 30), Baseline Visit (Day 0), Day 15 (Telephonic Follow up, Visit 1 (Day 30), Day 45 (Telephonic Follow up), Visit 2 (Day 60), Day 75 (Telephonic Follow up), Visit 3 (Day 90) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparative change in mild , moderate , severe migraine days
2. Comparative difference in 50% responder rate for the reduction of migraine days
3. Comparative difference in associated symptoms
4. Comparative assessment of use of rescue medications
5. Comparative difference in insomnia
6. Comparative difference in anxiety level
7. Global assessment of overall change
8. Global assessment of tolerability of study products
9. Assessment of adverse events.
10. Assessment of safety laboratory investigations
|
Screening Visit (up to Day 30), Baseline Visit (Day 0), Day 15 (Telephonic Follow up, Visit 1 (Day 30), Day 45 (Telephonic Follow up), Visit 2 (Day 60), Day 75 (Telephonic Follow up), Visit 3 (Day 90) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/05/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a randomized,
double blind, placebo controlled, multi-center, comparative, interventional,
prospective clinical study to evaluate efficacy and safety of MIGRA365 Capsule
in Participants Suffering from Episodic Migraine. The study will be carried out
at 4 to 5 centers in India. Subjects will be asked to take given
product (MIGRA365 capsule or matching
placebo) in a dose of 1 capsule twice daily orally after
meals with water for 3 months. Primary objective of the study will be to assess
comparative difference in number of monthly migraine
days. Secondary objectives of the study will be to assess comparative
change in mild/ moderate / severe migraine days based, comparative
difference in 50% responder rate for the reduction of migraine
days, comparative difference in associated symptoms, comparative
assessment of use of rescue medications, comparative
difference in insomnia,
comparative difference in anxiety level, global
assessment of overall change, global assessment of tolerability of study
products, assessment
of adverse events and safety laboratory investigations on Screening Visit (up to Day 30), Baseline Visit (Day
0), Day 15 (Telephonic Follow up, Visit 1 (Day 30), Day 45 (Telephonic Follow
up), Visit 2 (Day 60), Day 75 (Telephonic Follow up), Visit 3 (Day 90) |