| CTRI Number |
CTRI/2025/03/083266 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of nasal administration of dry ginger with milk in the management of migraine headache |
|
Scientific Title of Study
|
Effect of ksheeranagara Nasya in the management of 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 |
Arathi G |
| Designation |
Pg Scholar,Department of Panchakarma |
| Affiliation |
Government Ayurveda College hospital,al,ripunithura |
| Address |
Department of Panchakarma,Room number:135,Government Ayurveda college Hospital,Tripunithura,Ernakulam
Department of Panchakarma,Room number:135,Government Ayurveda College Hospital,Tripunithura,Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
07594026979 |
| Fax |
|
| Email |
drarathig@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shitha Thomas |
| Designation |
Associate Professor,Department pf Panchakarma |
| Affiliation |
Government Ayurveda College Hospital ,Kannur l |
| Address |
Department of Panchakarma,B block,Room number:B22,Government Ayurveda College and Hospital,Pariyaram ,Kannur
Department of Panchakarma,B block,Room number-B22,Government Ayurveda College Hospital,Pariyaram,Kannur,PIN:670503
Kannur
KERALA
670503
India |
| Phone |
09496368092 |
| Fax |
|
| Email |
drshitha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shitha Thomas |
| Designation |
Associate Professor,Department pf Panchakarma |
| Affiliation |
Government Ayurveda College Hospital ,Kannur l |
| Address |
Department of Panchakarma,B block,Room number:B22,Government Ayurveda College and Hospital,Pariyaram ,Kannur
Department of Panchakarma,Bblock,Room number-B22,Government Ayurveda College Hospital,Pariyaram,Kannur,PIN:670503
Kannur
KERALA
670503
India |
| Phone |
09496368092 |
| Fax |
|
| Email |
drshitha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Hospital,Tripunithura,Ernakulam,KERALA,682301,India |
|
|
Primary Sponsor
|
| Name |
Arathi G |
| Address |
PG Scholar,Department of Panchakarma,Room number:135,Government Ayurveda College Hospital,Tripunithura |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Arathi G |
Government Ayurveda College Hospital,Puthiyakavu,Tripunithura,Ernakulam |
Department of Panchakarma,Government Ayurveda college Hospital,Puthiyakavu,Tripunithura,Ernakulam.PIN-682301
Ernakulam
KERALA |
07594026979
drarathig@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee for ethics and research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: ARDHAVABEDAKAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtangahridaya, Procedure details: Nasya will be given at the time of Migraine attack with Ksheera nagara Nasya in uthama matra(8 bindu), consecutively for 7 days, in the morning hours between 7 to 9 am. Standardization of dose will be done as first phase of the study.
Standardization of dose
The dose of Nasya is selected as per the opinion of Vagbhata, mentioned in Ashtanga hridaya, suthrasthana, 20th chapter, named as Nasya vidhi. According to him the uttama matra of Nasya with kalka dravya is 8 bindu.
For standardization of 8 bindu pramana matra, 60 participants ranging from 18-60 years old will be selected. Each participants will be asked to dip up to proximal inter phalangeal joint of the right index finger in the prepared Ksheera nagara Nasya dravya". Then finger will be taken out and the quantity which was drippling down will be considered as one Bindu. As regards to the above mentioned method, total quantity of 8 Bindu will be calculated. Measurement of 60 participants will be taken and average will be calculated. The final calculated dose will be considered as standardized 8 bindu pramana dosage for doing Nasya karma.
Preparation of medicine and procedure
Prior to Nasya karma, standardization of bindu pramana will be done..
Ksheera nagaram will be prepared in the Panchakarma department under sterile condition.
Ksheeram (24 ml) will be boiled very well and then the paste of nagara (3g) is mixed well with it. After that, medicine will be sieved through cotton cloth and used for Nasya.
Fresh medicine will be prepared on each day.
Thila taila for abhyanga, cotton cloth to protect eyes while swedana will be arranged. Nadi sweda yantra for swedana, gokarna, disposable sterile plastic container for spitting, haridradi dhooma varthi, warm water for kavala will be made available.
PASCHATH KARMA
After completion of therapy, medicated dhoompana with haridradi varthi is given and kabala with lukewarm water to attain kandda sudhi
All procedure will be continued for 7 days.
Clinical assessment will be done on 0th day 8th day and 98th day.)
(1) Medicine Name: Nagara, Reference: Yogaratnakara, Route: Nasal, Dosage Form: Kalka/ Paste, Dose: 1(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Participants satisfying the migraine diagnostic criteria according to ICHD Criteria.
2)Those who are medically fit for Nasya karma
3)Participants irrespective of gender.
4)Age group between 18 to 60 years
5)Those who are able to give consent |
|
| ExclusionCriteria |
| Details |
1. Secondary headache caused by sinusitis, uncorrected refractive errors and increased intraocular pressure.
2. Patients with known cases of malignant diseases of head and neck, recent head trauma,and history of meningitis and encephalitis
3. Participants, diagnosed with complicated migraine such as status migrainosus, ophthalmic migraine, hemiplegic migraine, retinal migraine, basilar artery migraine.
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Migraine disability by MIDAS SCORE. |
All the participants will be assessed by subjective and objective parameters on 0th day,8th day,98th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Standardization of the dose of Ksheeranagara Nasya in bindu pramana
2. Assessment of the Samyak Nasya lakshana
3. Role of Nasya in prevention of recurrence of Migraine
4. Intensity of pain of Migraine by Visual Analogue Scale
5. Frequency of migraine attack
6. Duration of pain in Migraine
7. Associated symptoms of Migrain
|
All the participants will be assessed by subjective and objective parameters on 0th day, 8th day and 98th day.
|
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Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
31/03/2025 |
| 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="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
|
The trial is conducted to assess the effect of Ksheera nagara Nasya in Migraine. The intervention will be given as nasal administration of nagara kalka with milk in the dosage of 1 ml each nostril for a period of 7 consecutive days.The study will be conducted in Government Ayurveda Medical College Hospital,Tripunithura having facilities which makes the study more feasible.The study design is pre and post-study.A sample size of 34 will be selected based on inclusion and exclusion criteria. Data collection will be done through case proforma. Paranasal sinus examination will be done in order to rule out Sinusitis condition. Visual acuity test will be conducted to rule out incorrected refractive errors. Schiotz tonometry test will be done to avoid increased intra cranial pressure. Migraine assessment will be conducted according to "Migraine Disability Assessment Test scoring" ,and "Visual Analogue Scale" will be used to know severity of pain. In the treatment period, patient will be advised to report in OPD during 98th day for the assessment. Data collected will be statistically analyzed through appropriate tests and conclusion will be drawn. |