| CTRI Number |
CTRI/2015/06/005940 [Registered on: 22/06/2015] Trial Registered Retrospectively |
| Last Modified On: |
16/06/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
SUTASHEKHARA RASA FOR ORALLY AND BRIHAT JEEVAKADYA TAILA FOR NASAL DROP FOR MIGRAINE |
|
Scientific Title of Study
|
STUDY ON ARDHAVABHEDAKA(MIGRAINE) AND ITS MANAGEMENT WITH BRIHAT JEEVAKADYA TAILA NASYA AND SUTASHEKHARA RASA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHWETA MATA |
| Designation |
MS SCHOLAR |
| Affiliation |
IPGTRA GAU Jamnagar |
| Address |
Room no 44 PG Girls Hostel Institute for Post Graduate Teaching
and Research in Ayurveda GAU Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
09408536366 |
| Fax |
|
| Email |
shwetamatadr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D B Vaghela |
| Designation |
Assistant Professor |
| Affiliation |
IPGTRA GAU Jamnagar |
| Address |
Department of Shalakyatantra Institute for Post Graduate Teaching and
Research in Ayurveda GAU Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
09825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D B Vaghela |
| Designation |
Assistant Professor |
| Affiliation |
IPGTRA GAU Jamnagar |
| Address |
Department of Shalakyatantra Institute for Post Graduate Teaching and
Research in Ayurveda GAU Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
09825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda jamnagar 361008 |
| 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 |
| SHWETA MATA |
Institute for Post Graduate Training and Research in Ayurved |
Department of Shalakyatantra Institute for Post
Graduate Training and
Research in Ayurved
GAU Jamnagar
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
09408536366
shwetamatadr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Institute for Post Graduate Training and Research in Ayurved GAU Jamnagar 361008 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients suffering from Ardhavabhedaka, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
In Group A-Brihat jeevakadya Taila Nasya and Sutashekhara Rasa orally |
duration-45 days for group A. Nasya 2 sittings for 7 days at the interval of 15 days |
| Comparator Agent |
In Group B-Flunarizine-10mg |
duration-45 days for group B |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group 20 to 60 years, presenting with signs and symptoms of Ardhavabhedaka - Migraine described as per Ayurveda and modern science will be included in the study.
2. The diagnosis of the disease shall be done on the basis of clinical manifestations like recurrent attacks of headache, mostly unilateral in site, variable in intensity, frequency and duration with or without nausea, vomiting, aura and GI tract symptoms. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from any chronic debilitating disease, with other neurological pathology, E.N.T. pathology, stress headache and cases which required surgical intervention will be excluded from study.
2. Patients suffering from Sinusitis, Hypertension, Secondary headache caused by meningitis, tumor, encephalitis, cervical spondylitis and refractive errors will be excluded from study.
3. Patients using any other systemic drugs which may alter the results of study.
4. Patients who need psychiatric treatment will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement will be assessed on the basis of
relief found in cardinal symptoms of
diseaseProgress in the signs and symptoms
based on the standard pattern will be applied
before and after treatment. |
Improvement will be assessed on the basis of
relief found in cardinal symptoms of
diseaseProgress in the signs and symptoms
based on the standard pattern will be applied
before and after treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement will be assessed on the basis of
relief found in cardinal symptoms of
diseaseProgress in the signs and symptoms
based on the standard pattern will be applied
before and after treatment. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/09/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study is designed with the aim of evaluate efficacy of RIHAT JEEVAKADYA TAILA NASYA AND SUTASHEKHARA RASA in the management of Ardhavabhedaka(Migraine) in comparison of Fiunarizine
Group
A-Trial group: (1)Brihat Jeevakadya Taila Nasya: Dose For Nasya : 6
drops in each nostril. Duration:
Nasya will
be done for 2 sittings of seven days with the interval of 15 days after Each sitting. Total duration one and
half month. (2)Sutashekhara Rasa: Dose:
250mg BD Duration: one and half
month Form : Tablet Route of Administration : Oral
Anupana:
Drakshajala Group B control group: No.
of patients maximum 15
Flunarizine Tab
10mg
Dose: 1 tab. HS
Duration
: 45
days
Form
:
Tablet
Route of Administration : Oral CRITERIA
FOR THE ASSESSMENT :-The
efficacy of the therapy will be assessed on the basis of subjective and
objective criteria.
Subjective:
Relief in signs and symptoms in terms
of intensity, frequency, duration and no. of analgesics during attacks obtained
in the patients will be considered for the assessment. For this purpose main
signs and symptoms is given score according to their severity. The details of
the score adopted for the main signs and symptoms in this study will be given
in research proforma.
Objective:
Routine Examination and pain scale. Follow up: 1 month |