| CTRI Number |
CTRI/2024/05/067213 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Clinical study in the patients of Chronic and Refractory Migraine using an Ayurvedic Treatment Protocol |
|
Scientific Title of Study
|
Non-randomized observational clinical study in the patients of Chronic and Refractory Migraine using Ayurvedic Treatment Protocol |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaidya Balendu Prakash |
| Designation |
Ayurvedic Physician |
| Affiliation |
Padaav –Speciality Ayurvedic Treatment Centre |
| Address |
Padaav –Speciality Ayurvedic Treatment Centre, 146/4, Shantala plaza, 1st Floor, 8th Main, 14th Cross, Malleswaram, Bengaluru – 530003, Karnataka, India
Bangalore
KARNATAKA
530003
India |
| Phone |
9837028544 |
| Fax |
|
| Email |
balenduprakash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaidya Balendu Prakash |
| Designation |
Ayurvedic Physician |
| Affiliation |
Padaav –Speciality Ayurvedic Treatment Centre |
| Address |
Padaav –Speciality Ayurvedic Treatment Centre, 146/4, Shantala plaza, 1st Floor, 8th Main, 14th Cross, Malleswaram, Bengaluru – 530003, Karnataka, India
KARNATAKA
530003
India |
| Phone |
9837028544 |
| Fax |
|
| Email |
balenduprakash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaidya Balendu Prakash |
| Designation |
Ayurvedic Physician |
| Affiliation |
Padaav –Speciality Ayurvedic Treatment Centre |
| Address |
Padaav –Speciality Ayurvedic Treatment Centre, 146/4, Shantala plaza, 1st Floor, 8th Main, 14th Cross, Malleswaram, Bengaluru – 530003, Karnataka, India
KARNATAKA
530003
India |
| Phone |
9837028544 |
| Fax |
|
| Email |
balenduprakash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidya Chandra Prakash Cancer Research Foundation |
|
|
Primary Sponsor
|
| Name |
VCPC Research Foundation |
| Address |
Prakash Villa, NH 74, Rudrapur, Udham Singh Nagar - 263153, Uttarakhand
Mobile: 9837028544, 7983392736 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Vaidya Balendu Prakash |
Padaav - Speciality Ayurvedic Treatment Centre |
146/4, Shantala Plaza, 1st Floor, 8th Main, 14th Cross, Malleswaram
Bangalore
KARNATAKA |
9837028544
balenduprakash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G437||Chronic migraine without aura. Ayurveda Condition: SIROROGAH/SIRAHSULA/SIRASTAPA/SIROBITAPA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Narikel Lavan, Reference: Ras Tarangini, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: Buttermilk), Additional Information: -(2) Medicine Name: Rason Vati, Reference: Siddh Yog Sangrah, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: Hot water), Additional Information: -(3) Medicine Name: Godanti Mishran, Reference: Siddh Yog Sangrah, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: hs, Bhaishajya Kal: Antarabhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: NUMAX, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: With meal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who met the International Classification of Headache Disorders – 2nd Edition diagnostic criteria for migraine or chronic migraine and who remained refractory to treatment with conventional prophylactic medications |
|
| ExclusionCriteria |
| Details |
Other disease than Migraine |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of headache days |
Day 0, 30, 60, 90, 120, 180, 360 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intensity of pain (VAS), MIDAS score, associated
symptoms (mainly nausea, vomiting, phonophobia, photophobia) |
Day 0, 30, 60, 90 & 120 (treatment period) & Day 150, 180 & 360 (post treatment period) |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
15/07/2024 |
| 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="3"
Months="0"
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 - NO
|
|
Brief Summary
|
The study outlined is a non-randomized observational clinical trial designed to assess the effectiveness of an Ayurvedic Treatment Protocol in patients suffering from Chronic and Refractory Migraine. The study aims to enroll 300 participants aged 11–65 years who have remained unresponsive to conventional prophylactic medications. The treatment protocol involves oral administration of specific Ayurvedic medications, including Narikel Lavana, Numax, Rasonvati, and Godanti mishran. The primary objective is to evaluate the efficacy of the Ayurvedic treatment, measured by a change in the number of headache days and Visual Analog Scale (VAS) scores. Secondary objectives include assessing the frequency, duration, and severity of migraine attacks, as well as their impact on associated symptoms using the Migraine Disability Assessment Scale (MIDAS). The study incorporates eight scheduled visits over the 360-day period, and data capturing relies on the International Headache Society (IHS) diagnostic criteria, VAS, and MIDAS to ensure comprehensive evaluation. This observational study contributes to understanding the potential benefits of Ayurvedic interventions in managing Chronic and Refractory Migraine. |