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
|
|
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
|
|
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 | Comparator Arm | Drug | Classical | | (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: - | 2 | Intervention Arm | Drug | Classical | | (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. |