CTRI Number |
CTRI/2022/09/045891 [Registered on: 26/09/2022] Trial Registered Prospectively |
Last Modified On: |
21/09/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Non-randomized, Multiple Arm Trial |
Public Title of Study
|
Management of Ardhavbhedaka (Migraine) with Shirodhara and
through Nasal Administration Procedure |
Scientific Title of Study
|
A Clinical Study of "Gunja Taila Nasya" and "Dashmoola Shrit Ksheera Shirodhara" in the Management of Ardhavbhedaka (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 Madhu |
Designation |
MD Scholar |
Affiliation |
Upgiasr Dsrrau |
Address |
PG Department Of Panchkarma University Post Graduate Institute Of Ayurveda Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur
Jodhpur RAJASTHAN 342037 India |
Phone |
9050807620 |
Fax |
|
Email |
madhu17beniwal@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Gyan Prakash Sharma |
Designation |
Hod & Associate Professor |
Affiliation |
Upgiasr Dsrrau |
Address |
PG Department Of Panchkarma University Post Graduate Institute Of Ayurveda Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur
Jodhpur RAJASTHAN 342037 India |
Phone |
9829798701 |
Fax |
|
Email |
atreyagyan@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Madhu |
Designation |
MD Scholar |
Affiliation |
Upgiasr Dsrrau |
Address |
PG Department Of Panchkarma University Post Graduate Institute Of Ayurveda Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur
Jodhpur RAJASTHAN 342037 India |
Phone |
9050807620 |
Fax |
|
Email |
madhu17beniwal@gmail.com |
|
Source of Monetary or Material Support
|
Dr Sarvepalli Radhakrishnan Rajasthan Ayuved University Jodhpur |
|
Primary Sponsor
|
Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayuved University Jodhpur |
Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur Pin 342037 |
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 Madhu |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Hospital Of Ayurved |
Opd No 7 Pg Department Of Panchkarma Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur Pin 342037 Jodhpur RAJASTHAN |
9050807620
madhu17beniwal@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
THE INSTITUTIONAL ETHICS COMMITTEE UPGIASR JODHPUR |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | Navanam | (Procedure Reference: Charak Siddhi , Procedure details: Nasya will be performed in the morning time for a duration of 30 minutes) (1) Medicine Name: Gunja Taila Nasya, Reference: Bhasjhya Ratnawali, Route: Nasal, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Duration: 2 Weeks | 2 | Intervention Arm | Procedure | - | Kashayadhara | (Procedure Reference: Dhara Kalp, Procedure details: Kashayadhara will be performed in the morning time for 45 minutes) (1) Medicine Name: Dashmoola Shrit Ksheera Shirodhara, Reference: Bhavprakash Dravya Vargikaran, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 1500(ml), Frequency: od, Duration: 2 Weeks |
|
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
1.Diagnosed and confirmed cases of ardhavabhedaka (migraine) according to CRF.
2.Clinically Fit for Nasya Karma and Shirodhara.
3.Patients willing to give written consent.
|
|
ExclusionCriteria |
Details |
1.Patients who were suffering from secondary headaches like meningitis, brain tumor, encephalitis, cervical spondylitis, sinus, refractive errors & glaucoma.
2.Patients who were suffering from chronic disease like hypertension, COPD, renal disease etc.
3.Pregnant and lactating women.
4.A Patient of Ardhavbhedaka who was taking other treatment was 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 |
Subjective Criteria Based On Symptoms Of Disease
Objective Criteria
Midas (Migraine Disability Assessment Test)
Visual Analogue Score (Vas)
|
4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
To find out the comperative efficacy of the treatment in both groups With the help of MIDAS (Migraine Disability Assessment Test),
VISUAL ANALOGUE SCORE (VAS) and Symptoms of Disease |
4 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
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
|
28/09/2022 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NA |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Ardhavabhedaka is
a disease that usually manifest in the half part of head.
In Ayurveda Ardhavabhedaka is
counted in 11 types of Shirorogas. According to different
Aacharyas doshas involved in Ardhavabhedaka are:-
· Sushruta-
Sannipat i.e vata pitta kapha
· Charaka -Vata
/ vata-kapha
· Vagbhatta
- Vata
In Modern It can be well
correlated with “Migraineâ€. It is common neurovascular disease characterized by
periodic commonly throbbing , intense headache in one half of the head ,
majority of times in the temporal region with some associated symptoms like
nausea, vomiting, vertigo, photophobia etc. It is found in persons who are
anxious, rigid, perfectionists and who work hard to fatigue themselves. In allopathy
various drugs like NSAID’S Like acetaminophen, aspirin, ibuprofen, nausea
medicine, triptans, Ergotamine, CGRP receptor antagonists are being used to
counter the migraine. However some drugs are expensive and producing
several adverse effects like tingling, nausea, chest heaviness, fatigue,
depression, insomnia, dizziness, weight gain, dry mouth etc. so we are looking
to alternative system especially Ayurveda and try to find out solution for
migraine. Ayurveda plays unique role in management of the disease.
Aacharya’s explained that all the Panchkarma procedures are indicated for
Ardhavbhedaka. However Nasya karma and Shirodhara plays a vital role in
disintegrating the pathology of the disease. The study is open labelled parallel group trial to prove the efficacy of Gunja Taila Nasya and Dashmoola Shrit Ksheera Shirodhara in the management of Ardhavabhedaka (Migraine). In one group, 15 patients will be administered with Nasya and next 15 patients will be administered with Shirodhara. |