| CTRI Number |
CTRI/2024/09/073334 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative study of Treatment for migraine(Ardhavabhedaka) between sneha nasya and avapida nasya with oral medicine in both nasya. |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of asana bilwadi taila nasya and laghu soota shekhara rasa orally with shirish moola-beeja avapida nasya followed by go ghrita nasya and laghu soota shekhara rasa orally in the management of ardhavabhedaka W. S. R to migrane. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sugandha Rawat |
| Designation |
MS scholar |
| Affiliation |
Dr BRKR Govt Ayurveda college and hospital |
| Address |
room no 11 Dr BRKR govt ayurvedic hospital, Erragadda, Hyderabad, Telengana, India,
Hyderabad
TELANGANA
500038
India |
| Phone |
7999731928 |
| Fax |
|
| Email |
surbsk406@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Anasuya |
| Designation |
Principal |
| Affiliation |
Dr. BRKR govt. ayurvedic college and hospital |
| Address |
room no 11, Department of Shalakya tantra, Dr BRKR govt ayurvedic hospital, Erragadda, Hyderabad, Telengana, India,
Hyderabad
TELANGANA
500038
India |
| Phone |
9985266955 |
| Fax |
|
| Email |
kanasuya9191@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Anasuya |
| Designation |
Principal |
| Affiliation |
Dr. BRKR govt. ayurvedic college and hospital |
| Address |
room no 11,department of shalkya tantra ,Dr BRKR govt ayurvedic hospital, Erragadda, Hyderabad, Telengana, India,
TELANGANA
500038
India |
| Phone |
9985266955 |
| Fax |
|
| Email |
kanasuya9191@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BRKR Govt ayurveda college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr BRKR Govt ayurveda college and hospital |
| Address |
Erragadda, Hyderabad India.
pin code-500018 |
| 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 K Anasuya |
Dr BRKR Govt ayurveda college and hospital |
Room no 11,Department of Shalakya tantra,Dr BRKR Govt ayurveda college and hospital
Erragadda,Hyderabad
Hyderabad
TELANGANA |
9985266955
kanasuya9191@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee of Dr BRKR Govt ayurveda college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R51||Headache. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Sirovirecanam, शिरोविरेचनमॠ| (Procedure Reference: sushruta samhita, Procedure details: Poorva karma- snehana of face and neck will be done followed by mridu sweda.
Pradhana karma- nasya will be given(6 drops each nostril).
Paschata karma- kavala.)
(1) Medicine Name: asana bilwadi taila , Reference: sahasrayoga, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 21 Days(2) Medicine Name: laghu soota shekhara rasa, Reference: rasatantra sara siddha yoga sangriha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 45 Days | | 2 | Comparator Arm | Procedure | - | avapIDanam, अवपीडनमॠ| (Procedure Reference: sushruta samhita, Procedure details: Poorva karma-snehana of face-neck will be done first followed by mridu swedana.
Pradhana karma- avapida nasya will be given (6 drops each nostril).
Paschata karma-2 drops go ghrita nasya each nostril.kavala procedure. )
(1) Medicine Name: shirisha beeja - moola, Reference: sushruta samhita, Route: Nasal, Dosage Form: Swaras/ Juice, Dose: 6(drops), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Symptoms of migraine,ardha parshwa vedana,bhedatoda shoola,pakshat,dashahat akasmat vedana,photophobia,phonophobia,nausea,vomiting,vertigo,pain in manya-bhru-shankha-karna-akshi-lalaatardhe. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Patient suffering from major disease eg; Thyroid dysfunction, Diabetic mellitus, Heart disease, Cancer etc.
Opthalmoplegic migraine, Hemiplegic Migrane, Retinal Migrane, Basilar Migrane, Intractable Migrane.Complicated migraine, Status migranous.
Secondary headache caused by Meningitis, Brain tumour, Encephalitis, Cervical spondylitis, refractive error and Glaucoma.
Any other systemic disorders which interfere with the cause of the treatment will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS scale,MIDAS questionnare,grading on the basis of improvement of symptoms |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| increase in quality of life |
45 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 1 |
|
Date of First Enrollment (India)
|
14/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an open labelled randomised comparative human
clinical trial to evaluate the efficacy of Asana bilwadi taila nasya and
Shirish beeja-moola Avapida nasya ,where Laghu soota shikhara rasa (LSSR) will
be given orally to both groups in the management of Ardhavabhedaka WSR to Migrane..
Subject selection will be done randomly from GAH ,according
to inclusion and exclusion criteria.
Two groups of 20 subjects each will be given trial medicine.LSSR
will be given 3 days prior to Nasya to ensure Deepana karma.from fourth day nasya(either
taila shirovirechana or avapida nasya) both 6 drops each nostril will be given
for 7 days followed by 7 days gap for three times.thus 3 days oral medicine alone,21
days nasya with oral medicine,21 days gap with oral medicine alone completes 45
days trial.
Followup will be done after 21 days.
Appropriate statistical analysis will be done to assure the
result. |