| CTRI Number |
CTRI/2025/09/095168 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study, no trials involved. |
| Study Design |
Other |
|
Public Title of Study
|
Study of migraine with reference to Ardhavbheda from an Ayurvedic perspective |
|
Scientific Title of Study
|
Observational study of Nidanpanchak of Ardhacbhedaka 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 Nita Mahalle |
| Designation |
Professor |
| Affiliation |
Yashwantrao Chavhan Ayurved Medical College |
| Address |
Rognidan Department, 4th floor,
Yashwantrao Chavhan Ayurved Medical College,
Bhalgaon Nipani Beed highway,
Chatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431009
India |
| Phone |
9766199504 |
| Fax |
|
| Email |
nita.bhongade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Govind Asati |
| Designation |
Professor |
| Affiliation |
Government Ayurved College, Nagpur |
| Address |
Rognidan Department,
Government Ayurved College, Nagpur, Raje Raghuji Nagar, Umred Road, Sakkardara, Nagpur
Nagpur
MAHARASHTRA
440026
India |
| Phone |
9423401202 |
| Fax |
|
| Email |
govindasati26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Govind Asati |
| Designation |
Professor |
| Affiliation |
Government Ayurved College, Nagpur |
| Address |
Rognidan Department,
Government Ayurved College, Nagpur, Raje Raghuji Nagar, Umred Road, Sakkardara, Nagpur
Nagpur
MAHARASHTRA
440026
India |
| Phone |
9423401202 |
| Fax |
|
| Email |
govindasati26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College, Nagpur
Rognidan Department,
Raje Raghuji Nagar, Umred Road, Sakkardara, Nagpur, Maharashtra, India - 440026 |
|
|
Primary Sponsor
|
| Name |
Nita Mahalle |
| Address |
Department of Rognidan,
Yashwantrao Chavhan Ayurved College, Chatrapati Sambhajinagar, Maharashtra, India
431007 |
| Type of Sponsor |
Other [Self sposered] |
|
|
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 Govind Asati |
Government Ayurved College, Nagpur |
Rognidan Department, Room no2,
Raje Raghuji Nagar, Umred Road, Sakkardara, Nagpur - 440026
Nagpur
MAHARASHTRA |
9423401202
govindasati26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, GAC Nagpur |
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 |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with irrespective of there age, gender, social economical status and cooperative will included. Patients having sign and symptoms of migraine and Ardhavbhedaa according to Ayurvedic classics.
|
|
| ExclusionCriteria |
| Details |
Headache due to sinusitis, hypertension, fever. Secondary headache by meningitis, tumor, encephalitis, cervical spondylitis and refractive errors |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome - correlation between Ardhavbhedaka and Migraine as following aspects -
Assessment Criteria#1 - Lakshanas (Symptoms) of Ardhavbhedaka (Ardhaparshwa shula, Manyashula, Bhrushula, Shankhashula)
Assessment Criteria#2 - Symptoms of Migraine (Unilateral headache, Nausea, Vomiting, Photophobia, Lightheadness, Scalp tenderness)
Assessment Criteria#3 - Hetu of ardha (Ruksha Ahar, Adhyashaana, Pragvata, Atimithuna, Vegvidhrana, Ativayam, Anashana, Ratrijagrana)
|
50 weeks from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Hetus, Samprapti of Ardhavbhedaka w.s.r. to migraine |
50 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/10/2025 |
| 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="2"
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
|
A sincere attempt to understand the root causes of migraines from an Ayurvedic perspective focuses on identifying imbalances in the body’s doshas (Vata, Pitta, and Kapha). Migraines are often linked to Pitta aggravation, particularly in the head region, resulting in intense pain and associated symptoms. The pathogenesis explores how factors like diet, lifestyle, stress, and environmental triggers influence doshic imbalances. By applying Ayurvedic principles, early prevention and diagnosis can be enhanced, leading to more targeted treatments such as herbal remedies, dietary adjustments, and lifestyle modifications that address the underlying imbalances and promote long-term relief from migraines |