| CTRI Number |
CTRI/2025/03/081544 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic management of vatika sirahsula(migraine) |
|
Scientific Title of Study
|
comparative study of Sirahsuladrivjra rasa along with Pathyadi kvatha and nimbadi guggulu along with dashmula kvatha in vatika sirahsula w.s.r 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 Mansi Goklani |
| Designation |
PG Scholar |
| Affiliation |
J S Ayurveda Mahavidhyalaya |
| Address |
PG Department of kayachikitsa js ayurveda mahavidhyalaya college road nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9157283700 |
| Fax |
|
| Email |
thakkarmansi784@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Dhaval Dholakiya |
| Designation |
professor |
| Affiliation |
J S Ayurved Mahavidyalaya |
| Address |
PG Department of kayachikitsa js ayurveda mahavidhyalaya college road nadiad
kheda
gujarat
387001
india
Kheda
GUJARAT
387001
India |
| Phone |
7016786089 |
| Fax |
|
| Email |
vddhavaldholakiya1910@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Dhaval Dholakiya |
| Designation |
professor |
| Affiliation |
J S Ayurved Mahavidyalaya |
| Address |
PG Department of kayachikitsa js ayurveda mahavidhyalaya college road nadiad
kheda
gujarat
387001
india
Kheda
GUJARAT
387001
India |
| Phone |
7016786089 |
| Fax |
|
| Email |
vddhavaldholakiya1910@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurved Teaching pharmacy with J S Ayurveda Mahavidyalaya nadiad kheda gujarat 387001 india |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidhyalaya |
| Address |
college road nadiad kheda gujarat 387001 india |
| 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 Mansi Goklani |
P D patel ayurveda hospital |
PG Department of kayachikitsa js ayurveda mahavidhyalaya college road nadiad
kheda
gujarat
387001
india
Kheda
GUJARAT |
9157283700
thakkarmansi784@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institics commitee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: SIROROGAH/SIRAHSULA/SIRASTAPA/SIROBITAPA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: nimbadi guggulu, Reference: Dattram Sh. Krishanlal Mathur, Brihat Nighantu Ratnakar Part 6, Khemraja Shri Krishandas Prakashan, Mumbai, 1981, P-398, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: ushnodaka), Additional Information: -(2) Medicine Name: Dasamula kvatha, Reference: Sarangdhara Samhita, MadhyamaKhanda 2 Verse 28-31, 1st Edition. Edited by Dr. G. Prabhakar Rao. Varanasi: Chaukhamba Publications, 2013., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: sirahsuladri vajra rasa, Reference: Bhaisajya ratnavali, Sirorogadhikara, 140-144, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: ushnodaka), Additional Information: -(2) Medicine Name: pathyadi kvath, Reference: Sarangadhara Samhita, MadhyamaKhanda 2 Verse 143-145, 1st Edition. Edited by Dr. G. Prabhakar Rao. Varanasi: Chaukhamba Publications, 2013., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classically defined Migraine.
Migraine headache (without aura)- At least five attacks fulfilling criteria B through D from diagnostic criteria of migraine without aura.
Migraine headache (with aura) - At least five attacks fulfilling criteria B through D from diagnostic criteria of migraine with aura.
|
|
| ExclusionCriteria |
| Details |
Patients on corticosteroids, who received psycho pharmacological agents in last 6 months.
Pregnant and lactating women.
Patient having any other clinical condition i.e. Diabetes mellitus, Hyperthyroidism, Hypothyroidism, Cardiovascular disease, Tuberculosis and Parkinson’s disease.
Patient having any abnormal MRI which suggest critical conditions like SOL or patient having clinical condition of nausea/vomiting with seizures or acute psychological disturbances which clinically indicate SOL.
Patients suffering from Sinusitis, Hypertension, and Fever, Secondary headache caused by Meningitis, Tumor, Encephalitis, Cervical Spondylitis and Refractive errors.
patients using any other systemic drugs which may alter the results of the study were excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in signs and symptoms in the patients of vatika sirahsula (migraine) |
• Patient will be treated at O. P. D. level for 6 weeks of treatment schedule. They will come for follow-up after every 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in signs and symptoms in the patients of vatika sirahsula (migraine) |
• Patient will be treated at O. P. D. level for 6 weeks of treatment schedule. They will come for follow-up after every 2 weeks. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
03/03/2025 |
| 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="6"
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
|
Migraines cause a lot of physical, emotional and social challenges, greatly affecting your overall well-being. The usual drugs for treating migraines include regular painkillers like NSAIDs, opioids, barbiturates, combination analgesics and antiemetics, as well as migraine-specific medications such as triptans, ergot alkaloids and their derivatives. However, these treatments offer only temporary relief and have multiple side effects. Sirahsuladri vajra rasa and pathyadi kvatha are being used by many Ayurveda physician in routine practice with satisfactory results. Sirahsuladri vajra rasa is mentioned in bhesjyaratnavalli , pathyadi kvatha & dasamula kvatha in sarangadhar samhita whereas nimbadi guggulu in brhat nighantu ratnakara for the treatment of siroroga .Hence, nimbadi guggulu and dasamula kvatha may be effective in Vatika sirahsula .Till date no any comparative research work found on the above therapy for the management of vatika sirahsula (migraine). |