| CTRI Number |
CTRI/2023/06/054160 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
17/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study of Gunja taila on Migraine. |
|
Scientific Title of Study
|
Clinical evaluation of Gunja tail Nasya in Ardhavabhedaka (Migraine). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Bhatt |
| Designation |
PG Scholar |
| Affiliation |
Gurukul Campus, Uttrakhand Ayurved University, Haridwar |
| Address |
Department of Panchkarma
Gurukul Campus, Uttrakhand Ayurved University, Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9761008941 |
| Fax |
|
| Email |
dr.swatibhatt2405@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Uttam Kumar Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Gurukul Campus, Uttrakhand Ayurved University, Haridwar |
| Address |
Department of Panchkarma,
Gurukul Campus, Uttrakhand Ayurved University, Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9411149479 |
| Fax |
|
| Email |
druksm27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Uttam Kumar Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Gurukul Campus, Uttrakhand Ayurved University, Haridwar |
| Address |
Department of Panchkarma,
Gurukul Campus, Uttrakhand Ayurved University, Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9411149479 |
| Fax |
|
| Email |
druksm27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gurukul Campus, Uttrakhand Ayurved University, Haridwar
249404 |
|
|
Primary Sponsor
|
| Name |
Gurukul Campus Uttrakhand Ayurved University Haridwar |
| Address |
Gurukul Campus, Uttrakhand Ayurved University, Haridwar
249404 |
| 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 Swati Bhatt |
Gurukul Campus Uttarakhand Ayurveda University Haridwar |
OPD no. 24 Department of Panchakrma Haridwar Uttarakhand
Hardwar
UTTARANCHAL |
9761008941
dr.swatibhatt2405@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UTTARAKHAND AYURVED UNIVERSITY, DEHRADUN Office of the Campus Director/ Principal Gurukul Campus, Haridwar- 249404 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABHEDAKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gunja Taila, Reference: Bhaishajya Ratnavali Shirorogadhikara Ch. 65/153-156, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 4(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 33 Days, Reference: No, Route: -, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Roasted wheat powder capsules, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 33 Days, anupAna/sahapAna: Yes(details: water), Additional Information: Group B- Placebo control group
oral administration of roasted wheat powder capsules 1 capsule (500mg) BD. |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group 16-60 years.
2.Patient will be selected irrespective of sex,religion,occupation,habitat etc.
3.Patient with any classical symptoms of Ardhavabhedak/Migraine.
4.Patient having recurrent attack of headache with or without nausea,vomiting,aura.
5.Patient fit for Nasya karma. |
|
| ExclusionCriteria |
| Details |
1.Patient unfit for Nasya karma as mentioned in Ayurvedic reference books.
2.Patient having history of Head Trauma.
3.Pregnant women and Lactating mothers.
4.Patient having symptoms of Ophthalmoplegic migraine and Retinal migraine.
5.Known cause of headache like epilepsy, cysticercosis, brain tumor.
6.Systemic disorders that may interfere in the line of treatment like heart disease, kidney disease, hyperthyroidism, hypothyroidism.
7.Secondary headache caused by meningitis, tumor, encephalitis, cervical spondylitis, refractive errors and infectious disease.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement will be assessed on the basis of
subjective parameters- by Grading scale adopted for this study and MIDAS SCALE. |
Outcome will be assessed at baseline, 33 day, 48 day and 63 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
T.L.C
D.L.C
E.S.R
R.B.S
Urine examination- Routine and microscopic |
At baseline and 33 day. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
03/07/2023 |
| 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
|
NIL
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ardhavabhedaka is a type of Shiro-rog, characterised by severe tearing and pricking pain in Manya, Bhru, Shankha, Karna, Akshi and Lalata which is paroxysmal in nature and is very much resembles to Migraine. In Bhaisajyaratnavali, Acharya Govinddas Sen has indicated Gunja Taila nasya in Ardhavabhedaka. In this study we will administered Gunja Taila as Nasya in Group A and Placebo (Roasted wheat powder capsules) in Group B. |