| CTRI Number |
CTRI/2025/04/084946 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of panchbhautika nasal drops in the patients with migraine |
|
Scientific Title of Study
|
An open labelled randomized comparative clinical study to
evaluate the efficacy of panchbhautika nasal drops in the management of ardhavabhedaka with special reference to migraine |
| 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 Chandni Dav |
| Designation |
Pg Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Room no 406 Department of Shalakya Tantra Parul Institute of Ayurved Parul
University limda Tal Waghodia
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
6352863209 |
| Fax |
|
| Email |
chandnidav000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjiri keskar |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Room no 406 Department of Shalakya Tantra Parul Institute of Ayurved Parul
University limda Tal Waghodia
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9822606358 |
| Fax |
|
| Email |
manjirikeskar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjiri keskar |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Room no 406 Department of Shalakya Tantra Parul Institute of Ayurved Parul
University limda Tal Waghodia
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9822606358 |
| Fax |
|
| Email |
manjirikeskar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of ayurved parul university limda Vadodara Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute Ayurveda |
| Address |
Parul University
Vadodara
Gujarat 391760 |
| Type of Sponsor |
Private medical college |
|
|
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 Chandni Dav |
Parul Ayurved Hospital |
Department of Shalakya Tantra ENT OPD No 112 Parul Ayurveda Hospital Parul University Limda waghodia Vadodara Gujarat
Vadodara
GUJARAT |
6352863209
chandnidav000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Parul Institute of Ayurved Parul University |
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 | Classical | | (1) Medicine Name: Panchabhautika nasal drops, Reference: Kashyapa kalpa, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Panchabhautika taila, Reference: Kashyapa kalpa, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients will be enrolled in the study based on the diagnostic criteria for ardhavabhedaka migraine
2. Patients will be selected from 18-60 years Age group
3. Patients who will be fit for Pratimarsh Nasya karma |
|
| ExclusionCriteria |
| Details |
1. Patients of ardhavabhedaka migraine who are taking alternative medicines
2. Other known case of any systemic disease HTN COPD etc
3. Patients with conditions such as brain tumors meningitis cervical spondylitis
encephalitis referred pain refractive errors or glaucoma will not be enrolled in this
study
4. Contraindicated for nasal instillation Pratimarsh Nasya karma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Evaluate the Efficacy of Panchbhautika nasal drops in The Management of
Ardhavabhedaka with Special reference to Migraine |
At baseline on 15th day 30th day 45th day 60th day 75th day and 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relief from symptoms of migraine |
90 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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="1"
Months="0"
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
|
Introduction Ardhavabhedaka commonly known as a type of headache or migraine is primarily caused by an imbalance in the Vata dosha, and in some cases, a combination of Vata and Kapha according to the classical texts of Ayurveda Acharya Charaka Sushruta and Vaghbhata this condition is associated with factors that aggravate Vata including excessive consumption of dry or rough foods overeating improper food combinations excessive sexual activity suppression of natural urges and overexertion
The main symptoms include pain that affects half of the head Shira particularly in areas such as the forehead temples ears eyes and neck the condition is linked to an imbalance in the Vata dosha which causes pain and discomfort in these regions The disease is treated under the branch of Shalakya Tantra Urdhvanga Chikitsa which focuses on disorders related to the head and sensory organs
In essence ardhavabhedaka is a Vata dominated disorder and managing it requires addressing the underlying causes that disturb the balance of Vata with therapeutic approaches in Ayurveda focusing on balancing the doshas Need for study According to international headache society migraine have influence on 16% of the primary headache In today’s era 10-20% of general population suffer from migraine It is three times more common in women than men 3:1 in India more than 10 million cases per year migraine can be a challenging disease to diagnose only based on subjective criteria and it is verifiable only by the patient
Treatment of Migraine such as Analgesics Vasodilators available in present days ancient Acharyas have described various types of Nasya in the management of ardhavabhedaka so there is a need to re-establish or to search effective medicine for Migraine |