| CTRI Number |
CTRI/2025/09/094357 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare two Ayurvedic nasal therapies (Kumkumadi Ghrita Nasya and Shalparni Swaras Nasya) in patients with Migraine (Ardhavbhedaka) |
|
Scientific Title of Study
|
Comparative Clinical Evaluation Of Kumkumadi Ghrita Nasya And Shalparni Swaras Nasya In Ardhavbhedaka (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 |
Ananya Singh |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Address |
OPD 3, Department of Shalakya Tantra, Patanjali Ayurveda Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar,Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8787029307 |
| Fax |
|
| Email |
singhananya3011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar Agrawal |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Address |
OPD 3, Department of Shalakya Tantra, Patanjali Ayurveda Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar,Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9411551545 |
| Fax |
|
| Email |
agrawal.amitkumar308@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ananya Singh |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Address |
OPD 3, Department of Shalakya Tantra, Patanjali Ayurveda Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar,Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8787029307 |
| Fax |
|
| Email |
singhananya3011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan , Haridwar, Uttarakhand, India 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan , Haridwar, Uttarakhand,India 249405 |
| 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 Ananya Singh |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
OPD 3, Department of Shalakya Tantra, Patanjali Ayurveda Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar,Uttarakhand
Hardwar
UTTARANCHAL |
8787029307
singhananya3011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
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 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ch.Si. 89 /92, Procedure details: Poorva Karma -Abhyang with luke warm Til Taila will be done over Urdhwanga. Mridu Swedana will be given after covering the eyes with cotton swab.
Pradhan Karma- The selected dose of Shalparni Swaras Nasya will be administered in each nostril. patient is asked to inhale deeply.
Paschat Karma - Kavala with sukhoshna jal will be done. )
(1) Medicine Name: Shalparni Swaras Nasya , Reference: vangsen ,shiro rog, chikitsa sar sangrah 102, Route: Nasal, Dosage Form: Swaras/ Juice, Dose: 6(drops), Frequency: od, Duration: 14 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ch.Si. 89 /92, Procedure details: Poorva Karma -Abhyang with luke warm Til Taila will be done over Urdhwanga. Mridu Swedana will be given after covering the eyes with cotton swab. Pradhan Karma- The selected dose of Kumkumadi Ghrita Nasya will be administered in each nostril. patient is asked to inhale deeply. Paschat Karma - Kavala with sukhoshna jal will be done.)
(1) Medicine Name: Kumkumadi Ghrita Nasya, Reference: Shadangdhar Samhita, 3 khand , 8 Adhay 32,33, Route: Nasal, Dosage Form: Ghrita, Dose: 6(drops), Frequency: od, Duration: 14 Days |
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with classical signs & symptoms of Ardhavabhedaka (Migraine) described as per Ayurvedic and modern science.
2. Patients between the age group of 16 years to 60 years of either sex.
3. Patients in related group who are fit for Nasya Karma / Nasya yogya vyakti. |
|
| ExclusionCriteria |
| Details |
1. Patients less than 16 years and above 60 years of age.
2. Patients who are contraindicated for Nasya Karma.
3. Patients suffering from cluster headache, tension type of headache, sinus headache, and arising due to Meningitis ,Encephalitis, and Ocular manifestations.
4. Patient suffering from any systemic diseases like diabetes mellitus, heart disease, hypertension, cancer and receiving medication which may alter the results of study. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be done on the basis of subjective parameters
Intensity of Headache
Frequency of headache
Duration of Headache
Nausea
Vomiting
Vertigo
Aura |
Baseline (before treatment); Mid-treatment follow-up (Day 15); End of treatment (Day 21, primary time point). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done on the basis of subjective parameters |
Baseline (before treatment); Mid-treatment follow-up (Day 15); End of treatment (Day 21, primary time point). |
|
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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)
|
16/09/2025 |
| 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 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
|
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Brief Summary
|
in this trial , we are selecting the patients of Ardhavbhedaka in which we will do the intervention in two groups (30 patients in each group). In the group , we will intervene with ayurvedic procedure of nasya with Kumkumadi Ghrit Nasya for 14 days , whereas in other group, we will intervene with ayurvedic procedure of nasya with Shalparni Swara Nasya for 14 days . Assessment should be done on the basis of Subjective parameters and investigations done during pre-treatment and post treatment as discussed earlier.
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