CTRI Number |
CTRI/2022/08/044781 [Registered on: 22/08/2022] Trial Registered Prospectively |
Last Modified On: |
17/08/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Treatment of Migraine through Ayurvedic line of Management |
Scientific Title of Study
|
A Controlled Clinical Study To Evaluate The Effect Of Shalaparni Avapidana Nasya In The Management Of Ardhavabhedaka (Migraine Without Aura) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Syed Rasool Sufiyan |
Designation |
2nd Year Ms (Ayu) Scholar |
Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College |
Address |
Department Of Post Graduate Studies In Shalakya Tantra Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Centre Koppal
Koppal KARNATAKA 583231 India |
Phone |
8123101883 |
Fax |
|
Email |
syedrasoolsufiyan7@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Veerayya R Hiremath |
Designation |
Professor & Hod |
Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College |
Address |
Department Of Post Graduate Studies In Shalakya Tantra Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Centre Koppal
Koppal KARNATAKA 583231 India |
Phone |
9448544376 |
Fax |
|
Email |
drvrh.aug15@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Veerayya R Hiremath |
Designation |
Professor & Hod |
Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College |
Address |
Department Of Post Graduate Studies In Shalakya Tantra Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Centre Koppal
Koppal KARNATAKA 583231 India |
Phone |
9448544376 |
Fax |
|
Email |
drvrh.aug15@gmail.com |
|
Source of Monetary or Material Support
|
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College |
|
Primary Sponsor
|
Name |
Department Of Shalakya Tantra |
Address |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Centre |
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 |
Dr Syed Rasool Sufiyan |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Centre |
Department Of Shalakya Tantra Room No 01 Koppal KARNATAKA |
8123101883
syedrasoolsufiyan7@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:G430||Migraine without aura. Ayurveda Condition: ARDHAVABEDAKAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: (Procedure Reference: 8. Shri Govinda Dasji, Bhaishajya Ratnavali, Edited by Bhisagratna Shri Bhrahmashankar Mishra, English Translation by Dr. Kanjiv Lochan, Published by Chaukambha Sanskrit Sansthan, Varanasi, Reprint edition - 2014, Vol III, Shiroroga Adhikara, Chapter no, 65/35, page no,315., , Procedure details: Vidangadi Avapidana Nasya Each nostril 8 Bindu for 7 days))
| 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: (Procedure Reference: 7. Vaidya Shodhala, Gadanigraha, vidyotini hindi commentary of Sri Indradeva Tripathi, edited by Sri Ganga Sahaya Pandey, published by Chaukambha Sanskrit Sansthana Varanasi, Reprint edition - 2011, volume III chapter no,1/63, page no, 23.,, Procedure details: Shalaparni Avapidana Nasya Each nostril 8 Bindu for 7 days))
|
|
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Patients having the clinical features of Ardhavabhedaka (migraine without aura).
2. Patients aged between 16-60 years of either gender.
3.Patients suitable for Nasya Karma.
|
|
ExclusionCriteria |
Details |
1. Patients having history of a head trauma and other type of headache.
2. Patients having any inflammatory diseases in nose, PNS, eyes and ears.
3. Patients with other systemic disorders like hypertension, diabetes mellitus etc.
• Pregnant women and lactating mothers.
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To Observe Reduced in headache, nausea, photophobia and phonophobia |
In 7 Days |
|
Secondary Outcome
|
Outcome |
TimePoints |
To Observed Complete reduction in headache, nausea, photophobia, phonophobia |
In 21 Days |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
25/08/2022 |
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
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Ardhavabhedaka is a shiroroga1
characterized with severe sambheda (piercing), toda (pricking), shula
(pain), bhrama (giddiness) in one half side of the head. It relapses suddenly after ten days or
fortnight. According to acharya Sushruta, it is tridoshaja2
and according to acharya Charaka it is vataja or vata-kaphaja3.
Ayurveda emphasizes various treatment modalities of ardhavabhedaka which
includes Snehana (oleation), Swedana (fomentation), virechana (purgation),
Dhoopana (fumigation) and Sneha Bhojanam (unctuous food)4.
Ardhavabhedaka can be co-related with migraine.
Migraine is a
chronic neurological disease characterized by recurrent, moderate to severe
headaches often in association with autonomic nervous system symptoms.
According to International Headache Society, migraine constitutes 16% of the
primary headache and affects 10-20% of the general population. It is three
times more common in women than men, it is underdiagnosed
and undertreated, hence WHO ranks Migraine among the World’s most disabling
medical illness5. Current line of management advocates the use of analgesics
and anti-emetics in acute attacks. If not responding, vasoconstrictor like Argot
alkaloids are given. Sumatryptan has been used more successfully. Prophylaxis
of migraine may be achieved by Topiramate, Flunarizine and Propranalol etc6.
Even
though a lot of research on migraine with different treatment modalities has
been undergoing in bio-medical world, considerable number of world
population is suffering from this
disease without satisfactory relief. This raises the need to explore an
effective line of management for this disorder.
Shalaparni nasya7 and Vidangadi
nasya8 have been mentioned for Ardhavabhedaka Chikitsa.
Shalaparni is tikta madhura Rasa, guru Guna, ushna Virya, madhura
Vipaka and Tridoshahara. Vidanga is katu kashaya Rasa, laghu ruksha
tikshna sara Guna, ushna Virya, katu Vipaka, and Kaphavatahara in
nature and Krishna Tila is madhura Rasa, guru snigdha Guna, ushna Virya, madhura
Vipaka and Tridoshahara in nature.
Hence, present
study is being taken up to evaluate the effect of Shalaparni Avapidana Nasya
in the management of Ardhavabhedaka. Vidangadi Avapidana Nasya will be
taken as control drug. |