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CTRI Number  CTRI/2025/04/084416 [Registered on: 08/04/2025] Trial Registered Prospectively
Last Modified On: 15/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   A study to know the effect of chinnadi kashaya in migraine headache 
Scientific Title of Study   An open-label comparative clinical study to evaluate the efficacy of chinnadi kashaya in the management of ardhavabhedaka w.s.r to common 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 Kalunge Chetan Mahadev 
Designation  PG Scholar 
Affiliation  Muniyal institute of ayurveda medical sciences, manipal,udupi 
Address  Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi, karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9970434296  
Fax    
Email  chetukalunge143@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shripathi Acharya G 
Designation  Professor and Head of the department 
Affiliation  Muniyal institute of ayurveda medical sciences, manipal,udupial Sciences, Manipal 
Address  Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi, karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9845387720  
Fax    
Email  shripathi_acharya@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Kalunge Chetan Mahadev 
Designation  PG Scholar 
Affiliation  Muniyal institute of ayurveda medical sciences, manipal,udupi 
Address  Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi, karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9970434296  
Fax    
Email  chetukalunge143@gmail.com  
 
Source of Monetary or Material Support  
Muniyal instutute of ayurveda medical sciences,shivalli industrial area, manipal,udupi district,karnataka-576104 
 
Primary Sponsor  
Name  Muniyal instutute of ayurveda medical sciences,manipal,udupi. 
Address  Outpatient department of Kayachikitsa,Room no 4,Ground floor, Muniyal instutute of ayurveda medical sciences,manipal,udupi, Karnataka.576104 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kalunge Chetan Mahadev  Muniyal institute of ayurveda medical sciences, manipal,udupi  Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi, Karnataka 576104
Udupi
KARNATAKA 
9970434296

chetukalunge143@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Muniyal institute of ayurveda institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G430||Migraine without aura. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Pathyaksadhatryadi kashaya, Reference: Sharangadhara samhitha,Madhyama khanda,2nd chapter.verse no 143-145, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: guda), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Chinnadi kashaya, Reference: Bharat bhaishajya ratnakar.vol-2, Chakaradi kashaya prakarana,p.no 237, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: guda), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients with classical signs and symptoms of ardhavabhedaka(Common migraine) as mentioned in diagnostic criteria.
2) Patients aged between 18 to 60 years.
3)Patients irrespective of gender, religion, or occupation.
4)patients are willing to participate in the trial. 
 
ExclusionCriteria 
Details  1)Patients prediagnosed with tension headache or any other form of headache.
2)Patients prediagnosed with meningitis, brain tumors, encephalitis, cervical spondylosis, and also headaches due to refractive errors, glaucoma, and inflammatory diseases of the ear and nose.
3) Patients prediagnosed with coronary artery disease, uncontrolled diabetes, and accelerated hypertension
4)Patients prediagnosed with any malignancy, HIV, and any other chronic diseases.
5) Pregnant and lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To reduce the intensity of headache  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
To reduce frequency of headache, duration of headache, nausea, vomiting, photophobia, phonophobia.  30 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   10/04/2025 
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="4"
Days="20" 
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  
Migraine is the second most common cause of headache-related & indeed neurologic cause of disability in the world, it afflicts 15% of women & 6% of men over a year.

In Ayurveda, Ardhavabhedaka can be correlated with migraines. Acharya Charaka has specifically mentioned lakshanas of Ardhavabhedaka where Vedana in Ardha part of Shirah, Manya, Bhru, Sankha, Karna, Akshi & Lalata which is said to be shastra arni - nibha shoola. If left untreated, in extreme conditions, it can lead to Nasha of Nayanam & Shrotram.

Migraine is a syndrome of episodic recurrent headache, often unilateral, which is associated with nausea, vomiting, photophobia, or phonophobia. Women are more likely to experience migraines than males (2 to 3:1).

Migraine is one of the most common reasons for people to seek medical attention. Being the most severe type of headache, migraine sometimes has dramatic features of transient neurologic deficits, blinding headaches, nausea, and vomiting.

According to the World Health Organization, migraine is the third most frequent condition in the world with an estimated global frequency of 14.7%.

Drugs like Triptans and Ergotamine Tartrate are used in the treatment of Migraine, which is expensive and not commonly used in resource-poor countries. Many adverse effects, some of which may be minor or temporary, have been reported with migraine medications.

Another problem is the overuse of medicines, which causes medication overuse headaches (MOH), further complicating management strategies. Moreover, 5HT 1B/1D receptor agonist type of drugs used in migraine are contraindicated in individuals with a history of cardiovascular & cerebrovascular diseases. The average efficacy rate of oral agents is 50-70%.

Ayurvedic treatments for migraine are often favored due to their holistic approach, which aims to address the root cause rather than just symptoms. Ayurvedic management of migraine typically involves a combination of lifestyle modifications, dietary changes, herbal supplements, and therapies to balance the bodily doshas (Vata, Pitta, and Kapha).

Therefore, a treatment that provides results with no or very few side effects is needed to improve the quality of life of patients suffering from migraines. Treatment for relief and prevention of recurrence of the disease is necessary.

Hence, in this study, an effort will be made to assess the efficacy of Chinnadi Kashaya in managing Ardhavabhedaka and its comparison with Pathyaksadhatryadi Kashaya.
 
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