| CTRI Number |
CTRI/2024/08/072853 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Management of Migraine with Ayurvedic Interventions |
|
Scientific Title of Study
|
A Clinical study on Shira shoola wsr to Migraine and its management with RasnaDashamoola Kwatha and Kumari taila Nasya |
| 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 Pooja Khamari |
| Designation |
PG Scholar |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya |
| Address |
PG Department of Kayachikitsa
Gopabandhu Ayurveda Mahavidyalaya
VIP Road
Puri
Puri
ORISSA
752002
India |
| Phone |
8455054962 |
| Fax |
|
| Email |
mail2poojakhamari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonalika Jena |
| Designation |
Associate Professor |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya |
| Address |
PG Department of Kayachikitsa
Gopabandhu Ayurveda Mahavidyalaya
VIP Road
Puri
Puri
ORISSA
752002
India |
| Phone |
9437281398 |
| Fax |
|
| Email |
drsonalikajena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonalika Jena |
| Designation |
Associate Professor |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya |
| Address |
PG Department of Kayachikitsa
Gopabandhu Ayurveda Mahavidyalaya
VIP Road
Puri
Puri
ORISSA
752002
India |
| Phone |
9437281398 |
| Fax |
|
| Email |
drsonalikajena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gopabandhu Ayurveda Mahavidyalaya Vip Road Puri
Pin 752002
Odisha
India |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Khamari |
| Address |
PG Department of Kayachikitsa
Gopabandhu Ayurveda Mahavidyalaya
VIP Road
Puri
Pin 752002
Odisha
India |
| 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 Pooja Khamari |
Gopabandhu Ayurveda Mahavidyalaya |
Department of Kayachikitsa
Gopabandhu Ayurveda Mahavidyalaya
Vip Road
Puri
ORISSA |
8455054962
mail2poojakhamari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Gopabandhu Ayurveda Mahavidyalaya & Hospital,Puri,Odisha-752002 |
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, (2) ICD-10 Condition:G430||Migraine without aura. Ayurveda Condition: ARDHAVABEDAKAH, (3) ICD-10 Condition:G430||Migraine without aura. Ayurveda Condition: ARDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasnadashamoola Kwatha, Reference: Bruhat Nighantu Ratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -usna jala), Additional Information: - | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Bhabaprakash,Madhyama Khanda, Procedure details: Early morning & Evening 2 drops in each nostril to be advised )
(1) Medicine Name: kumari taila , Reference: Bhabaprakash,Madhyama khanda 62/42-48, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Headache
Nausea
Vomiting
Aura |
|
| ExclusionCriteria |
| Details |
Familial Hemiplegia
Complicated Migraine
ENT disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To get the serotonin level to normal levels and reduce the aura,frequency of attack |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the frequency of attacks and aura |
2 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
27/08/2024 |
| 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="2"
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
|
Clinical Study on Shirashoola wsr to Migraine is a Randomised,parallel group multiple arm trial of 2 months duration with Rasnadashamoola Kwatha and Kumari Taila Nasya.The primary outcome of this trial is to reduce serotonin,Vit B12 and Vit D to normal level and the secondary outcome is to cure the frequency of attacks along with aura. |