| CTRI Number |
CTRI/2021/07/034945 [Registered on: 16/07/2021] Trial Registered Prospectively |
| Last Modified On: |
15/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Shadbindu Tail Nasya and Shirahshooladivajra Rasa Orally in Aradhavabhedaka (Migraine) |
|
Scientific Title of Study
|
Evaluation of Shadbindu Tail Nasya and Shirahshooladivajra Rasa Orally in Aradhavabhedaka(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 Yogeshwar Arya |
| Designation |
P. G. Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar |
| Address |
O.P.D. no. 3, Department of Shalakya Tantra, Patanjali Ayuvedic Hospital, Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9424573987 |
| Fax |
|
| Email |
yogu.arya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Gupta |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar |
| Address |
O.P.D. no. 3, Department of Shalakya Tantra, Patanjali Ayuvedic Hospital, Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9997907340 |
| Fax |
|
| Email |
jyotiguptania@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Gupta |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar |
| Address |
O.P.D. no. 3, Department of Shalakya Tantra, Patanjali Ayuvedic Hospital, Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9997907340 |
| Fax |
|
| Email |
jyotiguptania@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayuvedic Hospital, Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurved College |
| Address |
Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Yogeshwar Arya |
Patanjali Ayurved Hospital |
O.P.D. no. 3, Shalakya Tantra Department, Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL |
9424573987
yogu.arya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PAC/IEC/2019-20/19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G43||Migraine. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
In Group A, Patients will be given Shadbindu Tail Nasya. |
Nasyam in nose 6 drop in each nostril once in a day
There will be 2 sittings of Nasya in 30 days.
First sitting - 7 days (1st
-7
th day)
Rest interval - 8 days
Second sitting - 7 days (16th
-22nd day)
Rest interval - 8 days |
| Comparator Agent |
In Group B, Patients will be given Shirahshooladivajra Rasa
Orally. |
Oral intake of Sirahshooladivajra Rasa for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical symptoms of Ardhavabhedaka(Migraine).
Patients in related group who are fit for Nasya Karma. |
|
| ExclusionCriteria |
| Details |
Patients less than 18 years and above 45 years of age.
Patients in related group who are contraindicated for Nasya Karma.
Patients suffering from any other forms of headaches apart from
Ardhavabhedaka (Migraine).
Patient suffering from any systemic diseases and receiving medication
which may alter the results of study. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters -
Severity of Headache
Frequency of Headache
Duration of Headache
Nausea
Vomiting
Vertigo
Aura |
Before intervention of Shadbindu Tail Nasya and Shirahshooladivajra Rasa Orally |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters -
Severity of Headache
Frequency of Headache
Duration of Headache
Nausea
Vomiting
Vertigo
Aura |
After intervention of Shadbindu Tail Nasya and Shirahshooladivajra Rasa Orally |
|
|
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 2 |
|
Date of First Enrollment (India)
|
21/07/2021 |
| 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
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this trial, we are selecting the patients of ardhavabhedaka in which we will do the intervention in two groups (20 patients in each group). In one group, we will intervene with ayurvedic therapy of nasya with shadbindu tail, whereas in other group, we will intervene with oral intake of ayurvedic drug, sirahshooladivajra rasa. Assessment will be done on the basis of subjective parameters and scoring will be done before and after the treatment. |