| CTRI Number |
CTRI/2024/03/064375 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Nasal route for drug administration with oral medicine] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of migraine |
|
Scientific Title of Study
|
A clinical evaluation of Guda Shunthi Avapeeda Nasya and Pathyadi Kwatha in the management of Ardhavbhedaka wsr to migraine an open label single arm study |
| 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 Kunjal Bhatt |
| Designation |
Professor |
| Affiliation |
J S ayurveda mhavidyalaya |
| Address |
Department of Shalakya Tnatra
J S ayurveda college
College road
Nadiad 387001
Gujarat
Department of Shalakya Tnatra
J S ayurveda college
College road
Nadiad 387001
Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
8128302560 |
| Fax |
|
| Email |
drkhbhatt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganga R Hadimani |
| Designation |
Professor |
| Affiliation |
J S ayurveda college |
| Address |
Department of Shalakya Tantra
J S Ayurveda college
College road
Nadiad
Gujarat
J S Ayurveda college
College road
Nadiad
Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
8780067570 |
| Fax |
|
| Email |
gangupatil2001@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganga R Hadimani |
| Designation |
Professor |
| Affiliation |
J S ayurveda college |
| Address |
Department of Shalakya Tantra
J S Ayurveda college
College road
Nadiad
Gujarat
J S Ayurveda college
College road
Nadiad
Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
8780067570 |
| Fax |
|
| Email |
gangupatil2001@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurveda teaching pharmacy of J S Ayurveda college Nadiad |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda college and P D Patel Ayurveda hospital |
| Address |
college road Nadiad Kheda Gujarat 387001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kunjal H Bhatt |
P D Patel Ayurveda hospital |
Department of Shalakya Tantra
J S Ayurveda college and P D Patel Ayurveda hospital
Kheda
GUJARAT |
8128302560
drkhbhatt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for human research |
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: Susruta Samhita, Procedure details: Juice will be procured by mixing Guda(Jaggery) & Shunthi churna and water. 4 drops of juice will be instilled in each nostril for seven days once in morning)
(1) Medicine Name: Guda(Jaggery) and Shunthi Churna, Reference: yog ratnakar, Route: Nasal, Dosage Form: Swaras/ Juice, Dose: 4(drops), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathyadi Kwatha, Reference: Sharandhar Samhita Madyam Khada, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Guda(Jeggary)), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pain in neck eyebrows temples ear eyes and frontal area
Pain on every 10 15 30 days interval or sudden onset
Nausea Vomiting vertigo Aura GI tract symptoms
Associated with sensitivity to light sound and movement
Chronicity of the disease up to 10 years
Nasya Yogya
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years and above 60 years
Chronicity of the disease more than 10 years will be excluded
Patients suffering from any chronic debilitating disease with other neurological pathology ENT pathology and cases which require surgical intervention will be excluded from study
Patients suffering from sinusitis, hypertension secondary headache caused by meningitis tumour encephalitis cervical spondylitis and refractive errors will be excluded from study
Patients using any other systemic drugs which may alter the results of study
Pregnant lady and lactating mother
Nasya Ayogya
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relief in headache in terms of frequency, duration and severity |
0 week, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in MIDAS score |
0 week, 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/03/2024 |
| Date of Study Completion (India) |
02/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The disease Ardhavbhedaka is included in Shiroroga in Ayurvedic classics having hemicrainal pain as its cardinal feature. The pain involves Pradhan Marma- Shira hence very troublesome for the patient.The symptoms of Ardhavbhedaka are similar to those of Migraine.In
the Global
Burden of Disease Study2010 (GBD2010), it was ranked as the third most prevalent
disorder in the world. In GBD2015, it was ranked third–highest cause
of disability worldwide in both males and females under the age of 50
years.[i] Almost 1.04 billion individuals were estimated to have
migraine. It caused 45.1 million YLDs(years of life lived with disability)
globally in 2016. It is most burdensome in women between ages 15 and 49 years,
causing 20.3 million YLDs in 2016, which was 11.2% of all YLDs in this age
group and sex. To get rid of the pain the patient has to take some medication which may show some side effects or durg dependancy or withdrawl symptoms. Ayurvedic manegement of migraine includes instillation of drug through nasal route (Nasya)along with oral medicines. This helps in reliving symptoms faster. Role of Nasya in Ardhavbhedaka is established but the specific combination of Guda(Jeggary) and Shunthi (powder of Gingibar officinale) Avapeeda Nasya has not been tried yet .In this study the relief in symptoms will be observed and difference in MIDAS score will be observed.
[i]https://ichd-3.org/1-migraine/
|