| CTRI Number |
CTRI/2025/02/080008 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical study of shadgranthadi taila nasya(medicated oiling in nostril) and ashwamritadi kwath (Decoction) in the management of Migraine |
|
Scientific Title of Study
|
A Clinical study of shadgranthadi taila nasya and ashwamritadi kwath in the management of ardhavabhedak w.s.r to migraine |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr HEMA BORYALE |
| Designation |
Post graduation schloar |
| Affiliation |
govt dhanwantari ayurvedic medical college and hospital Ujjain MP |
| Address |
Govt Dhanwantari ayurvedic medical college and hospital kayachikitsa department opd no 28 chimanjganj mandi ujjain MP 456006
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9617136987 |
| Fax |
|
| Email |
boryaleh1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr vandana saraf |
| Designation |
associate professor |
| Affiliation |
govt dhanwantari ayurvedic medical college and hospital Ujjain MP |
| Address |
Govt Dhanwantari ayurvedic medical college and hospital kayachikitsa department opd no 28 chimanjganj mandi ujjain MP 456006
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
8085740020 |
| Fax |
|
| Email |
vandana13ishnavi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr vandana saraf |
| Designation |
associate professor |
| Affiliation |
govt dhanwantari ayurvedic medical college and hospital Ujjain MP |
| Address |
Govt Dhanwantari ayurvedic medical college and hospital kayachikitsa department opd no 28 chimanjganj mandi ujjain MP 456006
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
8085740020 |
| Fax |
|
| Email |
vandana13ishnavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Dhanwantari Ayurvedic college and hospital chimanjgunj mandi ujjain, M.P., India , pin code- 456006 |
|
|
Primary Sponsor
|
| Name |
Govt Dhanwantari Ayurvedic college and hospital ujjain |
| Address |
Chimangunj mandi ujjain madhya pradesh, India Pincode-456006 |
| 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 Hema Boryale |
Govt Auto Dhanwantari ayurvedic medical college and hospital |
Chimangunj Mandi agar road , OPD no-28, Kayachikitsa Department, Ujjain, M.P. India, Pincode- 456006
Ujjain
MADHYA PRADESH |
9617136987
boryaleh1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee govt dhanwantari ayurvedic medical hospital ujjain |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G938||Other specified disorders of brain. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: ashwamritadi kwath, Reference: anubhut, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -no(2) Medicine Name: shadgranthadi tail, Reference: ch.su 2/5, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -no |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
all genders, patient with sign and symptoms of ardhavabhedak like ardha shirah shula, Hrillas (Nausea),Chardi (Vomiting), Bhrama (Vertigo), Sabdasahatha (Phonophobia), Prakashasahatha (Photophobia)
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Patients who have undergone surgery.
Patients having history for epilepsy, stroke, and head injury.
Malignancy, brain tumour.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce classical sign and symptoms of ardha shirah shula(Unilateral pain in head), hrillas(Nausea), chardi(Vomiting), shabdasahatha(PhonoPhobia), prakashasahatha(Photophobia), bhrama(Vertigo) |
To reduce classical sign and symptoms of ardha shirah shula(Unilateral pain in head), hrillas(Nausea), chardi(Vomiting), shabdasahatha(PhonoPhobia), prakashasahatha(Photophobia), bhrama(Vertigo) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effective management of ardhavabhedak by relieving the symptoms like ardha shirah shula, hrillas, chardi, shabdasahatha, prakashasahatha, bhrama |
After 2 month of study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/02/2025 |
| 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="0"
Months="2"
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 a Randomised interventional study of ashwamritadi kwath and shadgranthadi tail nasya on ardhavabhedak W.S.R.to migraine total 60 patients will be enrolled in present study. selected patients will be decided into three groups on the basis of computer generated randomisation group A containing 20 patients will be given ashwamritadi kwath and group B 20 patient given shadgranthadi tail nasya with placebo and group c 20 patient given ashwamritadi kwath and shadgranthadi tail nasya follow up will be on every 15 days |