| CTRI Number |
CTRI/2023/03/050429 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
03/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Agnikarma ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study of Agnikarma by Pippali in Migraine |
|
Scientific Title of Study
|
A Single arm clinical study to assess the role of Agnikarma by Pippali in Ardhavabhedaka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Juned Aslam Kothali |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurved college |
| Address |
Opd no 5 Shalakya Tantra Opd Ground floor Yashwant Charitable Hospital Near Sub district hospital Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9657555122 |
| Fax |
|
| Email |
juned.20kothali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Patil |
| Designation |
Associate Professor |
| Affiliation |
Yashwant Ayurved college |
| Address |
2nd Floor Department of Shalakya Tantra Yashwant Ayurved hospital Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9823421568 |
| Fax |
|
| Email |
dr.kp1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Juned Aslam Kothali |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurved college |
| Address |
Opd no 5 Shalakya Tantra Opd Ground floor Yashwant Charitable Hospital Near Sub district hospital Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9657555122 |
| Fax |
|
| Email |
juned.20kothali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurved College Near Sub District hospital Kodoli Tal Panhala Dist Kolhapur |
|
|
Primary Sponsor
|
| Name |
Dr Juned Aslam Kothali |
| Address |
Opd no 5 Shalakya Tantra Opd Ground floor Yashwant Charitable Hospital Near Sub district hospital Kodoli Tal Panhala Dist Kolhapur |
| Type of Sponsor |
Other [Self ] |
|
|
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 Juned Aslam Kothali |
Yashwant Ayurved college and hospital |
Department of Shalakya tantra OPD no 5 Ground floor Yashwant Ayurved college Kodoli Kolhapur
Kolhapur
MAHARASHTRA |
9657555122
juned.20kothali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G431||Migraine with aura. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Bhela Samhita , Procedure details: Single dose of Agnikarma by Pippali at Shira, end point of Lalata , Shankha pradesha and Manya on first visit/One day)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients showing signs and symptoms of Ardhavebhedaka like
Ardhashirvedana, prakashasahatva, bhrama, shabdasahatwa and hrullas
described as per Ayurvedic texts.
2.Patients of both genders of different socio-economic group will be selected
irrespective of caste and religion
3.Patients fit for Agni Karma.
|
|
| ExclusionCriteria |
| Details |
1)Patients with any other systemic disorders cerebral Hemorrhagic
Conditions, Hypertension, Major Vascular Diseases
2)Pathological conditions occurring in Eye, Ear, Nose, Throat and Teeth.
3)Patients who are suffering from secondary headaches like Meningitis, Brain
Tumour, Encephalitis, Cervical spondylitis and Glaucoma.
4)Pregnant and lactating women are excluded from the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the role of Agnikarma by Pippali in Ardhavabhedaka by subjective parameters like symptoms of Ardhavabhedaka and objective parameters like pain scale for headache |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To study the etio-pathology of Ardhavabhedaka in detail with classic ayurved texts
2 To observe the recurrence of disease after treatment
3To observe adverse effect of Agnikarma if any.
4To study the decrease in signs & symptoms of Ardhavabhedaka after Agnikarma treatment
5 To achieve outcome in 30 days
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Single arm clinical study to assess the role of Agnikarma by Pippali in Ardhavabhedaka. Observations will be made upon symptoms of Ardhavabhedaka. Study will be carried in OPD of Shalakya Tantra Department of Yashwant Ayurved College & Hospital Kodoli |