| CTRI Number |
CTRI/2025/09/095169 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to see the effect of Gandharyadi Ghrita in the Management of Ardhavabhedaka (Migraine) |
|
Scientific Title of Study
|
A Randomized Clinical study of Nasya with Gandharyadi Ghrita in the
Management of Ardhavabhedaka wsrt 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 Prajakta korde |
| Designation |
PhD Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College and Hospital of Ayurveda Pune 43 |
| Address |
OPD number 21 Panchkarma Bharati Vidyapeeth (Deemed to be University) College and Hospital of Ayurveda,
Bharati Vidyapeeth, Dhanakwadi, Pune, Maharashtra 411043
OPD number 21 Panchkarma Bharati Vidyapeeth (Deemed to be University) College and Hospital of Ayurveda,
Bharati Vidyapeeth, Dhanakwadi, Pune, Maharashtra 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7747047664 |
| Fax |
|
| Email |
prajakta.korde48@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh E Chavan |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College and Hospital of Ayurveda Pune 43 |
| Address |
OPD number 21 Panchkarma Bharati Vidyapeeth (Deemed to be University) College and Hospital of Ayurveda,
Bharati Vidyapeeth, Dhanakwadi, Pune, Maharashtra 411043
OPD number 21 Panchkarma Bharati Vidyapeeth (Deemed to be University) College and Hospital of Ayurveda,
Bharati Vidyapeeth, Dhanakwadi, Pune, Maharashtra 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9822249807 |
| Fax |
|
| Email |
drsantoshchavan5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajakta korde |
| Designation |
PhD Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College and Hospital of Ayurveda Pune 43 |
| Address |
OPD number 21 Panchkarma Bharati Vidyapeeth (Deemed to be University) College and Hospital of Ayurveda,
Bharati Vidyapeeth, Dhanakwadi, Pune, Maharashtra 411043
OPD number 21 Panchkarma Bharati Vidyapeeth (Deemed to be University) College and Hospital of Ayurveda,
Bharati Vidyapeeth, Dhanakwadi, Pune, Maharashtra 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7747047664 |
| Fax |
|
| Email |
prajakta.korde48@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) College and Hospital of Ayurveda,
Bharati Vidyapeeth, Dhanakwadi, Pune, Maharashtra 411043 |
|
|
Primary Sponsor
|
| Name |
Dr Prajakta korde |
| Address |
OPD number 21 Panchkarma Bharati Vidyapeeth (Deemed to be University) College and Hospital of Ayurveda,
Bharati Vidyapeeth, Dhanakwadi, Pune, Maharashtra 411043 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prajakta korde |
Bharati Vidyapeeth College and Hospital of Ayurved Dhankawadi Pune-43 a, Dhanakwadi, Pune-43 |
Panchkarma OPD number 21
Pune
MAHARASHTRA |
07747047664
prajakta.korde48@gmail.com |
| Dr Prajakta korde |
Ram Krishna College of Ayurved and Medical Sciences Bhopal-462033 |
Panchakarma OPD number 4
Bhopal
MADHYA PRADESH |
7747047664
prajakta.korde48@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 | Intervention Arm | Procedure | - | nasyam (viShopakramaH), नस्यम् (विषोपक्रमः) | (Procedure Reference: , Procedure details: Volunteers will be selected as per inclusion criteria.
Migraine of volunteers will be assessed by using MIDAS scale.
Volunteers with moderate & severe migraine levels will be suggested for
Nasya karma with Nasya karma in with
Gandharyadi Ghrita group B.
Gandharyadi Ghrita Nasya Karma will be giving for 14 days alternate days to Group B.
Assessment will be done by using MIDAS scale after the completion of
Nasya Karma.
Follow up will be taken for sustainability of Nasya Karma will be taken
by using MIDAS scale on interval of 1st 15th 30th 60th 90th 120th day )
| | 2 | Comparator Arm | Procedure | - | nasyam (viShopakramaH), नस्यम् (विषोपक्रमः) | (Procedure Reference: , Procedure details: Volunteers will be selected as per inclusion criteria.
Migraine of volunteers will be assessed by using MIDAS scale.
Volunteers with moderate & severe migraine levels will be suggested for
Nasya karma with Shadbindu Taila in group A.
Shadbindu Taila Nasya will be giving for 14 days alternate days to control
Group A.
Assessment will be done by using MIDAS scale after the completion of
Nasya Karma.
Follow up will be taken for sustainability of Nasya Karma will be taken
by using MIDAS scale on interval of 1st 15th 30th 60th 90th 120th day
)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a history of at least five migraine episodes, but not currently
experiencing an active episode, were enrolled in this clinical trial.
2) Moderate to Severe Migraine Patients.
3) Age Group: 25 Yrs. To 50 Yrs.
4) Sex : Male And Female Both
5) The Volunteers Who Duly Signed the Concern Form Will Be Considered.
6) Yogya for Nasya Karma.(as per classical indications).
7) Ability to follow the treatment schedule and attend follow-up visits. |
|
| ExclusionCriteria |
| Details |
1)Structural brain pathology,incranial lesion or history of head trauma.
2)Action episode of Migraine.
3)Non vascular and psychiatric disorder.
4)severe systemic illness like uncontrolled diabetes, hypertension, epilepsy.
5)H/O or K/C/O bleeding disorder.
6) known allergy to ingredients of Gandharvyadi ghrit or shadbindu taila |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in frequency of migraine (Ardhavabhedak) attacks: Measured as the number of episodes per month before and after intervention.
2. Reduction in intensity of headache: Assessed using the MIDAS Scale.
|
Sustainability of nasya karma will be taken by using Midas scale interval of 1st 15th 30th 60th 90th 120th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in duration of migraine episodes: Measured in hours per episode before and
after treatment.
2. Improvement in associated symptoms: Such as nausea, vomiting, photophobia,
phonophobia is using a symptom severity grading scale or patient diary.
3. Quality of life improvement: Assessed using a validated tool like MIDAS Scale.
4. Adverse events related to Nasya therapy: Monitoring for any side effects or discomfort
caused by the intervention.
5. Nasya Karma offers cost-effective and sustained relief in Ardhavabhedaka by
reducing symptoms, improving sleep, and enhancing mental clarity, with added social
and economic benefits like fewer sessions, minimal resource use, and reduced long-
term medication needs.
|
sustainability of Nasya Karma will be taken
by using MIDAS scale on interval of 1st 15th 30th 60th 90th 120th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/10/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Migraine of volunteers will be assessed by using MIDAS scale. Volunteers with moderate and severe migraine levels will be suggested for Nasya karma with Shadbindu Taila in group A (50 Patients) and Nasya karma with Gandharyadi Ghrita in group B (50 Patients ) for alternate days for 14 days Assessment will be done by using MIDAS scale after the completion of Nasya Karma to check the
sustainability of Nasya Karma will be taken by using MIDAS scale on interval of 1st 15th 30th 60th 90th 120th day |