| CTRI Number |
CTRI/2024/05/066843 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of Nasya with or without oral medication in the management of Migraine |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of Bala Guduchayadi Tail Nasya with or without oral administration of Khandasama Churana in the management of Ardhavbhedaka 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 Megha Pathak |
| Designation |
PG Scholar (Deptt. of Panchakarma) |
| Affiliation |
Dayanand Ayurvedic college |
| Address |
Deptt. of Panchakarma,Dayanand Ayurvedic College,Mahatama Hansraj Marg,Jalandhar(Pb),India
Jalandhar
PUNJAB
144008
India |
| Phone |
8847396895 |
| Fax |
|
| Email |
pathakgenius1947@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parveen Kumar |
| Designation |
Associate Professor (Deptt. of Panchakarma) |
| Affiliation |
Dayanand Ayurvedic college |
| Address |
Deptt. of Panchakarma,Dayanand Ayurvedic College,Mahatama Hansraj Marg,Jalandhar(Pb)
Jalandhar
PUNJAB
144008
India |
| Phone |
7589303536 |
| Fax |
|
| Email |
drparv1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Pathak |
| Designation |
PG Scholar(Deptt. of Panchakarma)) |
| Affiliation |
Dayanand Ayurvedic college |
| Address |
Department of Panchakarma,Dayanand Ayurvedic College,Mahatama Hansraj Marg,Jalandhar(Pb),India
Jalandhar
PUNJAB
144008
India |
| Phone |
8847296895 |
| Fax |
|
| Email |
pathakgenius1947@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Ayurvedic College,Mahatama Hansraj Marg,Jalandhar,Punjab,India,144008 |
|
|
Primary Sponsor
|
| Name |
Dayanand Ayurvedic College |
| Address |
Dayanand Ayurvedic College,Mahatama Hansraj Marg,Jalandhar(Pb),India,144008 |
| Type of Sponsor |
Private 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 Megha Pathak |
Dayanand Ayurvedic College |
Department of Panchakarma,Dayanand Ayurvedic College,Mahatama Hansraj Marg,Jalandhar(Pb),India 144008
Jalandhar
PUNJAB |
8847396895
pathakgenius1947@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DAV Institutional Ethical Committee |
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 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: sahastrayogam tailyog prakaran,charak samhita siddhi sthan, Procedure details: Nasya will be given for 14 days.
Dosage-3 ml each nostril))
(1) Medicine Name: khandsama churna, Reference: sahastrayogam churanyog prakaran, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient who are willing for study.
Patients who fulfills the classical symtoms of Ardhaavbhedhaka (Migraine) and fulfilling ICHS criteria
Patients of age more than 16 years and not more than 60 years irrespective of sex, religion & occupations will be selected for the study.
 Patients fit for Nasya |
|
| ExclusionCriteria |
| Details |
Patients not willing for study.
 Patients suffering from any other forms of headache apart from Ardhaavbhedhaka.
 Headaches secondary to medical conditions like Meningitis, Tumor, encephalitis, Spondylosis or any other intracranial lesions and Refractive errors etc.
 Patients with complications of Migraine e.g status migrainosus, migraine aura triggered seizure, probable migraine etc |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Bala Guduchayadi Tail Nasya in the management of Ardhavbhedaka w.s.r. to Migraine
ï‚· To evaluate the efficacy of Bala Guduchayadi Tail Nasya with oral administration of Khandasama Churna in the management of Ardhavbhedaka
ï‚· To compare the efficacy of Nasya Karma with or without oral administration of Khandasama Churna in the management of Ardhavbhedaka |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To provide economic, easily manageable, permanent and adverse affect free treatment for migraine |
28 days |
|
|
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 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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
|
In this clinical trial,total 60 patients will be selected on the basis of sign and symptoms.These 60 patients will divided into 2 groups named Group A and Group B.In Group A, Bala Guduchayadi Tail Nasya will be given along with oral administration of Khandasama Churna and in Group B, Bala Guduchayadi Tail Nasya will be given and will conduct a clinical trial to evaluate the efficacy of Bala Guduchayadi Tail Nasya in the management of Ardhavbhedaka w.s.r. to Migraine; To evaluate the efficacy of Bala Guduchayadi Tail Nasya with oral administration of Khandasama Churna in the management of Ardhavbhedaka and To compare the efficacy of Nasya Karma with or without oral administration of Khandasama Churna in the management of Ardhavbhedaka.The total duration of study will be 18 months. |