| CTRI Number |
CTRI/2025/01/079446 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Chinnaadikashaya Ghanvati and Pathyayadikashaya Ghanvati along with Patha Moola Taila Nasyam in Ardhavabhedaka (Migraine) |
|
Scientific Title of Study
|
A Comparative Study of Chinnaadikashaya Ghanvati and Pathyayadikashaya Ghanvati along with Patha Moola Taila Nasyam in the management of Ardhavabhedaka (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 Ritu |
| Designation |
MD Scholar |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Madhya Pradesh |
| Address |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Department of Kayachikitsa OPD No.1 Room No.1 Ground Floor Nehru Nagar Bhopal Madhya Pradesh
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Department of Kayachikitsa OPD No.1 Room No.1 Ground Floor Nehru Nagar Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9813269160 |
| Fax |
|
| Email |
dr.ritu25rajmukesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Meshram |
| Designation |
Associate Professor |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Madhya Pradesh |
| Address |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Department of Kayachikitsa OPD No.1 Room No. 1 Ground Floor Nehru Nagar Bhopal Madhya Pradesh
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Department of Kayachikitsa OPD No.1 Room No.1 Ground Floor Nehru Nagar Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425024816 |
| Fax |
|
| Email |
dr.rajeshmeshram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritu |
| Designation |
MD Scholar |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Madhya Pradesh |
| Address |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Department of Kayachikitsa OPD No.1 Room No.1 Ground Floor Nehru Nagar Bhopal Madhya Pradesh
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Department of Kayachikitsa OPD No.1 Room No.1 Ground Floor Nehru Nagar Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9813269160 |
| Fax |
|
| Email |
dr.ritu25rajmukesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Nehru Nagar Bhopal Madhya Pradesh 462003 |
|
|
Primary Sponsor
|
| Name |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute |
| Address |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Nehru Nagar Bhopal Madhya Pradesh 462003 |
| Type of Sponsor |
Government medical college |
|
|
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 Ritu |
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute |
Department of Kayachikitsa OPD No. 1 Room No.1 Ground Floor Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH |
9813269160
dr.ritu25rajmukesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G43||Migraine. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chinnaadikashaya Ghanvati and Pathyayadikashaya Ghanvati , Reference: Sarangdhar Samhita, Bharat Bhaisajya Ratnakar and Gad Nigrah, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -water/Gudoudak), Additional Information: -Along with Patha Moola Taila Nasyam |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with signs and symptoms of Ardhavabhedaka (Migraine) according to the Ayurveda
Classics and modern text.
2. Disease chronicity should be less than 2 years.
3.Patient willing to sign the consent form for participation in this study. |
|
| ExclusionCriteria |
| Details |
1. Patient age < 20 and > 60 years.
2. Referred pain in one half of the head due to disorder of eye, ear, nose, throat, teeth will be excluded.
3. Patient having migraine with aura, familial hemiplegic migraine, complicated migraine and other
neurological disorders, brain tumour or other space occupying region.
4. Patient suffering from tuberculosis, hypertension, cardiovascular disease, malignancy, and or any other
general debilitating health conditions.
5. Pregnant and lactating women.
6. Patient not willing to be registered for study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of study the efficacy of Chinnaadikashaya Ghanvati and Pathyayadikashaya Ghanvati along with Patha Moola Taila Nasyam will be determined in the management of Ardhavabhedaka/ Migraine |
8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
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)
|
17/02/2025 |
| 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="0"
Months="1"
Days="15" |
|
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 affects over one billion people globally, with a prevalence of 11.6%, and is especially common among young adults and women. Chronic migraine impacts around 2% of the population, and NSAIDs like ibuprofen and naproxen are commonly used for treatment, though they can cause gastrointestinal issues. As a result, many people turn to Ayurvedic remedies. Pathyaadikashaya ghanvati is a well-known Ayurvedic treatment for migraines, but there is limited research on Chinnaadikashaya ghanvati combined with Patha Moola Taila Nasyam. This study aims to evaluate the effectiveness of Chinnaadikashaya ghanvati in treating migraines and compare it to Pathyaadikashaya ghanvati. The formulation is noted for being cost-effective, easy to prepare, and palatable, offering a potential alternative to conventional treatments. |