| CTRI Number |
CTRI/2024/10/075551 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study the Effect of ayurvedic nasal drops in migraine |
|
Scientific Title of Study
|
Prospective controlled clinical study to evaluate the efficacy of Brihat Dashmoola Taila Nasya in 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 Neha Vivekanand Ladvikar |
| Designation |
PG Scholar |
| Affiliation |
Ayurved Seva Sangha Ayurved Mahavidyalaya,Nashik |
| Address |
OPD NO 20 Department of Panchakarma Ayurved Seva Sangh Ayurved Mahvidyalaya Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9657168701 |
| Fax |
|
| Email |
nehaladvikar567@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita A Kulkarni |
| Designation |
Professor and PG Guide |
| Affiliation |
Ayurved Seva Sangha Ayurved Mahavidyalaya,Nashik |
| Address |
Ayurved Seva Sangh Ayurved Mahavidyalaya, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9423081487 |
| Fax |
|
| Email |
drsavitak07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita A Kulkarni |
| Designation |
Professor and PG Guide |
| Affiliation |
Ayurved Seva Sangha Ayurved Mahavidyalaya,Nashik |
| Address |
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9423081487 |
| Fax |
|
| Email |
drsavitak07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
|
|
Primary Sponsor
|
| Name |
Dr Neha Vivekanand Ladvikar |
| Address |
Ayurved Seva Sangh Ayurved Mahvidyalaya , Nashik |
| 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 Neha Vivekanand Ladvikar |
Arogtashala Rugnalaya |
OPD no 20 Panchakarma Department Ayurved Seva Sangh Ayurved Mahavidyalaya, Ganeshwadi, Nashik
Nashik
MAHARASHTRA |
9657168701
nehaladvikar567@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
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 | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Charak samhita siddhisthana 9/88, Procedure details: Nasya procedure as per the text once a day in the mornig for 15 days)
(1) Medicine Name: Brihat Dashamoola Taila, Reference: Bhavprakash Shiroroga Adhikara 65/94, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Charak samhita siddhisthana 9/88, Procedure details: Nasya procedure as per the text once a day for 15 days)
(1) Medicine Name: Anu Taila, Reference: Bharat Bhaishajya Ratnakar part 1, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from signs and symptoms oF Ardhavabhedaka for more than 3 months
Ardhaparshwa (Unilateral) Shoola (Pulsating throbbing type of pain)
Pakshat Dashahat Akasmat (Paroxysmal)
Prakasha Asahishnuta (Photophobia)
Shabdaasahishnuta ( phonophobia)
Patients Arha for NasyaKarma fit for Nasya Karma
MIDAS score greater than or equal to 6
|
|
| ExclusionCriteria |
| Details |
Patients suffering from chronic debilitating disease with other neurological pathology E.N.T. and opthalmic pathology referred pain meningitis sepsis and requiring surgical intervention
Patients Anaharyafor Nasya Karma or contraindicated for Nasya Karma
Patients suffering from psychiatric pathology
Pregnant and lactating women
Patients using any other systemic drug that may alter the results of study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in migraine pain |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in MIDAS score |
15 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
25/10/2024 |
| 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="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
|
Current study is based on the ayurvedic approach in the management of Ardhavabhedaka with special reference to Migraine using MIDAS score. Sample size is 72. Improvement in symptoms of Ardhavabhedaka and reduction in MIDAS score will be evaluated. Two groups are selected group A and group B. In group A patients will be treated with Brihat Dashmool Taila Nasya for 15 days and in group B patients will be treated with Anu Taila Nasya for 15 days and symptommatic relief and depletion in MIDAS score will be calculated. |