| CTRI Number |
CTRI/2024/08/071896 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO ASSESS THE EFFICACY OF DASHMOOLA GHRITA NASYA IN MIGRAINE IN RELATION TO CGRP BIOMARKER |
|
Scientific Title of Study
|
SINGLE ARM CLINICAL TRIAL TO ASSESS THE EFFICACY OF DASHMOOLA GHRITA MARSHA NASYA IN MIGRAINE IN RELATION TO CGRP BIOMARKER |
| 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 HIMANI BINJI |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School Of Ayurveda
Panchakarma Department
room no 2
kollam
KERALA
690525
Other |
| Phone |
09910928016 |
| Fax |
|
| Email |
himanibinji5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K P Namboothiri |
| Designation |
Head of Department |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda
kollam kerala
Panchakarma Department
KERALA
690525
India |
| Phone |
9496096694 |
| Fax |
|
| Email |
kpn@ay.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr. K P Namboothiri |
| Designation |
Head of Department |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School Of Ayurveda
Kerala
Panchakarma Department
room no 2
KERALA
690525
India |
| Phone |
9496096694 |
| Fax |
|
| Email |
kpn@ay.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda Clappana PO Kollam Kerala 690525 |
|
|
Primary Sponsor
|
| Name |
Dr HIMANI BINJI |
| Address |
Amrita School Of Ayurveda
Kerala 690525
Panchakarma department
room no 2 |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Dr Himani Binji |
Amrita Ayurveda Hospital |
Amrita School of Ayurveda
Department of Panchakarma
Room no 2
Kollam
KERALA |
9910928016
himanibinji5@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Amrita School of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G430||Migraine without aura. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Nasya | (Procedure Reference: Charaka Sushruta , Procedure details: Abhyanga & swedana of face is done after this ask the patient ti lie down comfortably in supine position & cover the eyes & then dashmoola ghrita is administered the drug through both the nostrils simultaneously & after the procedure again do the abhyanga and swedana of face.)
(1) Medicine Name: Dashmoola Ghrita , Reference: Bhaishajya Ratanvali , Route: Nasal, Dosage Form: Ghrita, Dose: 8(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
•Participants who fits the Diagnostic criteria according to American Headache Society.
•Migraine disability assessment score (MIDAS) is above 11.
•Participants who fits Nasya Karma.
|
|
| ExclusionCriteria |
| Details |
•Secondary headaches due to an underlying condition, such as trauma, infection, vascular disorders.
•Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
CGRP level
Migraine Disability Assessment Score |
0th day (screening)
7th day (after the treatment)
14th day (follow up)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Migraine Assessment Disability Score is assessed before (0th day), after (7th day) and follow up (14th day) and Quality of Life assessment is done. |
0th day (screenning)
7th day (after)
14th day (follow up) |
|
|
Target Sample Size
|
Total Sample Size="13"
Sample Size from India="13"
Final Enrollment numbers achieved (Total)= "13"
Final Enrollment numbers achieved (India)="13" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2024 |
| Date of Study Completion (India) |
20/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Migraine is correlated with Ardhavabhedaka in ayurveda and the line of treatment of ardhavabhedhaka is nasya. In Migraineurs CGRP level is found elevated Efficacy of Dashmoola Ghrita Marsha nasya has already been proved in Migraine The efficicay of dashmoola ghrita marsha nasya in Migraine has been studied but in relation to CGRP biomarker has not been studied. Hence this study is proposed. |