| CTRI Number |
CTRI/2021/03/031745 [Registered on: 05/03/2021] Trial Registered Prospectively |
| Last Modified On: |
30/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized Clinical Trial to Evaluate the Effect of Ayurvedic Nasal Drop with and without Food Preparation. |
|
Scientific Title of Study
|
A Randomized Clinical Trial to Evaluate the Preventive Effect of Anutaila Pratimarsha Nasya with and without Badampaka in Ardhavbhedaka w.s.r to Chronic Migraine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashi Bala Saini |
| Designation |
M.D (Ayu.) Scholar Department of Swasthavritta and Yoga |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Post Graduate Department of Swasthavritta and Yoga National Institute of Ayurveda Madhav Vilas Palace Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7340566588 |
| Fax |
|
| Email |
shashibalasainis2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Kumar Agrawal |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda,Jaipur |
| Address |
Post Graduate Department of Swasthavritta and Yoga National Institute of Ayurveda Madhav Vilas Palace Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8058697177 |
| Fax |
|
| Email |
drsarvesh1008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashi Bala Saini |
| Designation |
M.D (Ayu.) Scholar Department of Swasthavritta and Yoga |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Post Graduate Department of Swasthavritta and Yoga National Institute of Ayurveda Madhav Vilas Palace Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7340566588 |
| Fax |
|
| Email |
shashibalasainis2@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Post Graduate Department of Swasthavritta and Yoga National Institute of Ayurveda Madav Vilas Palace Amer Road Jaipur |
| 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 Shashi Bala Saini |
National Institute of Ayurveda |
OPD No.-21 National Institute of Ayurveda Hospital Jaipur
Jaipur
RAJASTHAN |
7340566588
shashibalasainis2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of National Institute of Ayurveda |
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
|
| Type |
Name |
Details |
| Intervention |
Anutaila Pratimarsha Nasya And Badampaka will be given. |
Anutaila will be given 2 drops in each nostril, twice a day that is in morning and evening.
ï‚· Badampaka will be given in 50 gm dose in morning with lukewarm milk. |
| Comparator Agent |
Anutaila Pratimarsha Nasya will be given. |
Anutaila will be given 2 drops in each nostril, twice a day that is in morning and evening.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to participate in this trial through written informed consent.
2. Patients between 18 to 60 years of age of either sex.
3. Patients fulfilling the criteria of chronic migraine and Ardhavbhedaka.
4. Patients who are taken modern drug for headache. |
|
| ExclusionCriteria |
| Details |
1. Secondary headaches caused by meningitis, tumors, encephalitis, head and neck trauma, trigeminal neuralgia, cervical spondylitis, refractive errors, sinusitis and other disorders of cranium, neck, eyes, ears, nose, sinuses, teeth etc.
2. Patients with complicated migraine like status migrainosus, hemiplegic Migraine and having any chronic debilitating disease with other neurological pathology.
3. Pregnant and lactating women
4. Patients suffering from any other major systemic disorders e.g. tuberculosis, cancer, heart disease etc
5. Lactose intolerance patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptomatic relief in headache. |
8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| withdrawal of modern drug in Ardhavbhedaka w.s.r to chronic migraine during trial. |
8 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/03/2021 |
| Date of Study Completion (India) |
07/05/2021 |
| Date of First Enrollment (Global) |
08/03/2021 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
NEED FOR STUDY ï‚· Migraine though not a life-threatening disease but can have a devastating and disruptive effect on normal living. ï‚· Migraine sufferers experience not only excruciating pain, but social seclusion, disturbances in personal relationships and prejudices in the workplace. ï‚· At present time the allopathic painkiller medicines are given to relive the symptoms of migraine but there is no complete treatment of this disease. Infect the condition of patient versions some time and he required more medication or medicines are not effective. ï‚· Ayurveda therapy may be very useful in the prevention and management of migraine. ï‚· After the continuous treatment the frequency of migraine attacks become less and finally it is completely cured. OBJECTIVES Primary objective :To compare the preventive effect of Anutaila Pratimarsha Nasya with and without Badamapaka in Ardhavbhedaka w.s.r to chronic migraine Secondary objective: To assess the withdrawal of modern drug in Ardhavbhedaka w.s.r to chronic migraine during trial. ASSESSMENT CRITERIA For assessment of the efficacy of the trial therapy, following parameters will be adopted : 1. Intensity of pain: by Visual Analogue Scale (VAS) 2. Duration of pain: in hours 3. Frequency of Headache: in 2 weeks 4. Frequency of migraine type of Headache: in 2 weeks 5. Associated symptoms: nausea, vomiting, photophobia, vertigo, tinnitus, aura, transient loss/ blurring of vision, phonophobia, nasal discharge, sleep disturbance, stiffness of neck. 6. Frequency of allopathic painkillers which the patient taking already: in 2 week. |