| CTRI Number |
CTRI/2019/02/017837 [Registered on: 27/02/2019] Trial Registered Prospectively |
| Last Modified On: |
26/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Shadbindhu Ghrita and Pathyadi Kashaya in Migraine |
|
Scientific Title of Study
|
A clinical study on the combined effect of Shadbindhu Ghrita Prathimarsha Nasya and Pathyadi Kashaya pana in the management of Ardhavabhedaka (Migraine) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Anish Jose |
| Designation |
PG Scholar |
| Affiliation |
SDM College of Ayurveda and Hospital |
| Address |
Department of Shalakyatantra
SDM College of Ayurveda and Hospital,Thaneeruhalla,Hassan-573201,Karnataka.
Thaneeruhalla,BM Road, Hassan-573201,Karnataka.
Hassan
KARNATAKA
573201
India |
| Phone |
8056602320 |
| Fax |
|
| Email |
s.anishjose93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amarnath H K |
| Designation |
Associate Professor |
| Affiliation |
SDM College of Ayurveda and Hospital |
| Address |
Department of Shalakyatantra
SDM College of Ayurveda and Hospital,Thaneeruhalla,Hassan-573201,Karnataka.
Thaneeruhalla,BM Road, Hassan-573201,Karnataka.
Hassan
KARNATAKA
573201
India |
| Phone |
9242469001 |
| Fax |
|
| Email |
amarnath.hk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amarnath H K |
| Designation |
Associate Professor |
| Affiliation |
SDM College of Ayurveda and Hospital |
| Address |
Department of Shalakyatantra
SDM College of Ayurveda and Hospital,Thaneeruhalla,Hassan-573201,Karnataka.
Thaneeruhalla,BM Road, Hassan-573201,Karnataka.
Hassan
KARNATAKA
573201
India |
| Phone |
9242469001 |
| Fax |
|
| Email |
amarnath.hk@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
S Anish Jose |
| Address |
Department of Shalakyatantra
SDM College of Ayurveda and Hospital,Thaneeruhalla,Hassan-573201,Karnataka. |
| Type of Sponsor |
Other [Self funded] |
|
|
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 S Anish Jose |
SDM COLLEGE OF AYURVEDA AND HOSPITAL |
Department of Shalakyatantra,OPD-2, Thaneeruhalla,Hassan-573201,Karnataka.
Hassan
KARNATAKA |
8056602320
s.anishjose93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee SDM college of Ayurveda and Hospital Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Shadbindhu Ghritha
Pathyadi Kashaya |
Shadbindhu Ghrita is instilled two drops to each nostrils twice a day for a period of 30 days
Pathyadi Kashaya will be administered 15 ml orally twice a day before food for a period of 30 days
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient fulfills the diagnostic criteria
Already treated case/fresh case
Willing and able to participate and ready to sign consent form
|
|
| ExclusionCriteria |
| Details |
Migraine with aura
Severe depression or psychiatric disorders
Referred pain in head due to other disorders of ear, nose, throat, eyes, teeth
and neck
Patient contraindicated for Nasya
Patient under continuation of other system of medication for Migraine
Presence of Unilateral headache due to Sinusitis, Hypertension
Presence of Cluster headache, Tension headache, Trigeminal Neuralgia
Using of drugs like Alcohol, Chlorpromazine, Hydrochlorothiazide,
Anti anxity agents, Antidepressants, Antipsychotics, Antispasmodics, Antihistamines and Diuretics
Patient diagnosed with systemic diseases
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Role function restrictive
Role function preventive
Emotional function
|
30th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Role function restrictive
Role function preventive
Emotional function
|
30th day |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/02/2019 |
| 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="5"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Migraine specific quality of life questionnaire (version 2.1)
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
an single arm clinical study on the combined effect of Shadbindhu ghrita prathimarsha nasya and pathyadi kashaya pana in the management of ardhavabhedaka(migraine),the medicine is given for a period of 30 days and at the end of the treatment the role function,role preventive and the role restrictive domains of Migraine will be assessed using Migraine specific quality of life questionnaire (version 2.1) |