| CTRI Number |
CTRI/2022/02/039906 [Registered on: 01/02/2022] Trial Registered Prospectively |
| Last Modified On: |
22/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of mashadi taila nasya and pathyadi kashaya in the management of migraine |
|
Scientific Title of Study
|
A CLINICAL STUDY ON THE COMBINED EFFECT OF MASHADI TAILA MARSHA NASYA AND PATHYADI KASHAYA IN THE MANAGEMENT OF ARDHAVABHEDAKA WITH SPECIAL REFERENCE TO 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 Deeksha R |
| Designation |
PG scholar |
| Affiliation |
SDM College of Ayurveda, Hassan |
| Address |
#118, 2nd cross, 1st main, CFTRI layout, Bogadhi 2nd stage, Mysore
Department of Shalakya Tantra, 2nd year PG classroom, SDM college of Ayurveda and Hospital, Bangalore-Mangalore highway, Tanniruhalla, Hassan-573201
Hassan
KARNATAKA
570026
India |
| Phone |
9483483373 |
| Fax |
|
| Email |
deeksha118@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijith H N |
| Designation |
Asst Professor |
| Affiliation |
SDM College of Ayurveda, Hassan |
| Address |
Department of Shalakya tantra, SDM College of Ayurveda, Bangalore Mangalore Highway, Tanniruhalla, Hassan - 573201
SDM college of Ayurveda and Hospital, Bangalore-Mangalore highway, Tanniruhalla, Hassan-573201
Hassan
KARNATAKA
573201
India |
| Phone |
9482973869 |
| Fax |
|
| Email |
drabhijithhn@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijith H N |
| Designation |
Asst Professor |
| Affiliation |
SDM College of Ayurveda, Hassan |
| Address |
Department of Shalakya Tantra, SDM College of Ayurveda, Bangalore- Mangalore highway, Tanniruhalla, Hassan - 573201
SDM college of Ayurveda and Hospital, Bangalore-Mangalore highway, Tanniruhalla, Hassan-573201
Hassan
KARNATAKA
573201
India |
| Phone |
9482973869 |
| Fax |
|
| Email |
drabhijithhn@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda and Hospital, Bangalore Mangalore Highway, Tanniruhalla, Hassan - 573201 |
|
|
Primary Sponsor
|
| Name |
Dr Deeksha R |
| Address |
SDM College of Ayurveda and Hospital, Bangalore-Mangalore Highway, Tanniruhalla, Hassan-573201 |
| Type of Sponsor |
Other [] |
|
|
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 Deeksha R |
SDM college of ayurveda and hospital |
Department of Shalakya Tantra, SDM college of Ayurveda and Hospital, Bangalore-Mangalore Highway, Tanniruhalla, Hassan -573201
Hassan
KARNATAKA |
9483483373
deeksha118@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mashadi taila and Pathyadi kashaya |
Mashadi taila will be given for Marsha nasya(16 drops to each nostril) for 7 days and Pathyadi kashaya 15ml BD after food for 15 days. pathient will be followed up on 7th and 15th day |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient who fulfill the diagnostic criteria OF Ardhavabhedaka(Migraine) as quoted in Ayurveda samhithas and ICHD-3
Patient of either gender of age between 18 to 60 years
Both fresh and treated case will be considered for the study
Criteria for Diagnosing Migraine without Aura will be based on ICHD-3 1.119
A . At least five attacks fulfilling criteria B–D
B . Headache attacks lasting 4–72 h (untreated or unsuccessfully treated)
C . Headache has at least two of the following characteristics:
ï‚· Unilateral location
ï‚· Pulsating quality
ï‚· Moderate or severe pain intensity
ï‚· Aggravation by or causing avoidance of routine physical activity (e.g.,
walking or climbing stairs)
D . During headache at least one of the following:
ï‚· Nausea and/or vomiting
ï‚· Photophobia and phonophobia
E . Not better accounted for by another ICHD-3 diagnosis |
|
| ExclusionCriteria |
| Details |
Migraine with aura.
Severe depression or psychiatric disorders.
Referred pain in one half of head due to disorders of ear, eye, nose, teeth
and neck.
Unilateral headache due to sinusitis, Hypertension.
All patients contraindicated for marsha nasya.
Patients who are using drugs like alcohol, chlorpromazine,
hydrochlorothiazide, anti-anxiety agents, antidepressants, antipsychotics,
antispasmodics, antihistamines and diuretics
Patients under continuation of other system of medication for migraine
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of mashadi taila nasya and pathyadi kashaya in ardhavabhedaka(migraine) |
Baseline, 7th day, 14th day, 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of mashadi taila marsha nasya and pathyadi kashaya in ardhavabhedaka(migraine) |
31st 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
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2022 |
| 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 one of the shirorogas characterized by severe pain in one half of the head which when not treated or poorly treated may lead to complications like destruction of eye and ears (Nayana and Sravana vinasha). Nasya is the main treatment indicated in all urdhwajatrugata rogas. The formulation, mashadi taila is indicated in all types of Shirorogas. Pathyadi Kashaya is specifically mentioned for Ardhavabedhaka. Drugs in Mashadi Taila posses the properties which are mainly vatahara (pacifies vata dosha), acts as shiroartinut (Pacifies headache). The drugs in Pathyadi Kashaya are tridoshahara and are specifically indicated for Ardhavabedhaka. Mashadi taila is a simple taila preparation with three ingredients and Pathyadi kashaya has eight drugs which can be easily procured. Hence, these two formulations have been selected to access their combined effect on Ardhavabedhaka (Migraine).
OBJECTIVES- To evaluate the combined effect of Mashadi Taila marsha nasya and pathyadi kashaya in the management of Ardhavabedaka with special reference to Migraine
METHODOLOGY METHODOLOGY: Interventional clinical study RESEARCH DESIGN Open labeled single arm prospective clinical trial SOURCE OF DATA: 30 Patients will be selected from Out-patient department and In-patient department of Shalakya Tantra, Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, Hassan. SAMPLING TECHNIQUE: Convenient sampling SAMPLE SIZE: 30 DIAGNOSTIC CRITERIA: Criteria for Diagnosing Migraine without Aura will be based on ICHD-3 1.119 A . At least five attacks fulfilling criteria B–D B . Headache attacks lasting 4–72 h (untreated or unsuccessfully treated) C . Headache has at least two of the following characteristics:  Unilateral location  Pulsating quality  Moderate or severe pain intensity  Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) D . During headache at least one of the following:  Nausea and/or vomiting  Photophobia and phonophobia E . Not better accounted for by another ICHD-3 diagnosis INCLUSION CRITERIA  Patient who fulfill the diagnostic criteria  Patient of either gender of age between 18-60 years  Both fresh and treated case will be considered for the study Exclusion Criteria:  Migraine with aura.  Severe depression or psychiatric disorders.  Referred pain in one half of head due to disorders of ear, eye, nose, teeth and neck.  Unilateral headache due to sinusitis, Hypertension.  All patients contraindicated for marsha nasya.  Patients who are using drugs like alcohol, chlorpromazine, hydrochlorothiazide, antianxiety agents, antidepressants, antipsychotics, antispasmodics, antihistamines and diuretics  Patients under continuation of other system of medication for migraine  Pregnant and lactating women |