| CTRI Number |
CTRI/2021/06/034009 [Registered on: 04/06/2021] Trial Registered Prospectively |
| Last Modified On: |
31/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical trial to study the effects of two drugs,Nimbadi guggulu and Pathyashadangam Ghanavati in patients with Migraine. |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED CLINICAL TRIAL ON THE EFFICACY OF
NIMBADI GUGGULU IN THE MANAGEMENT OF 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 |
Amritha Mohan |
| Designation |
PG SCHOLAR |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPT OF P.G. STUDIES IN SHALAKYA TANTRA
ALVA‟S AYURVEDA MEDICAL COLLEGE AND HOSPITAL
MOODBIDRI, D.K, KARNATAKA-
DEPT OF P.G. STUDIES IN SHALAKYA TANTRA
ALVA‟S AYURVEDA MEDICAL COLLEGE AND HOSPITAL
MOODBIDRI, D.K, KARNATAKA-
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9567390630 |
| Fax |
|
| Email |
amrithamohan69@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apeksha D Rao |
| Designation |
Associate Professor |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPT OF P.G. STUDIES IN SHALAKYA TANTRA
ALVA‟S AYURVEDA MEDICAL COLLEGE AND HOSPITAL
MOODBIDRI, D.K, KARNATAKA-
DEPT OF P.G. STUDIES IN SHALAKYA TANTRA
ALVA‟S AYURVEDA MEDICAL COLLEGE AND HOSPITAL
MOODBIDRI, D.K, KARNATAKA-
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7411360991 |
| Fax |
|
| Email |
drapekshadrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apeksha D Rao |
| Designation |
Associate Professor |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPT OF P.G. STUDIES IN SHALAKYA TANTRA
ALVA‟S AYURVEDA MEDICAL COLLEGE AND HOSPITAL
MOODBIDRI, D.K, KARNATAKA-
DEPT OF P.G. STUDIES IN SHALAKYA TANTRA
ALVA‟S AYURVEDA MEDICAL COLLEGE AND HOSPITAL
MOODBIDRI, D.K, KARNATAKA-
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7411360991 |
| Fax |
|
| Email |
drapekshadrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakya Tantra,3rd floor,Alvas Ayurveda Medical College and Hospital,Moodbidri, Vidyagiri |
|
|
Primary Sponsor
|
| Name |
DR AMRITHA MOHAN |
| Address |
AMRITHAM, KAIRALI NAGAR 2ND, (PO) PILATHARA, KANNUR, KERALA, 670501 |
| 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 |
| DR AMRITHA MOHAN |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
3rd FLOOR
Department of P.G Studies in Shalakya Tanta,
Alva’s Ayurveda Medical College and Hospital,
Moodbidri, D.K District, Karnataka-574227
Dakshina Kannada
KARNATAKA |
9567390630
amrithamohan69@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITITIONAL CLINICAL ETHICS COMMITTEE ALVAS AYURVEDA MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: MIGRAINE, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIMBADI GUGGULU |
PATIENT HAVE TO ORALLY INTAKE 2 TABLETS OF 500 mg TWICE A DAY ALONG WITH WATER FOR 30 DAYS |
| Comparator Agent |
PATHYADI GHANAVATI |
PATIENT HAVE TO ORALLY INTAKE 2 TABLETS OF 500 mg TWICE A DAY ALONG WITH WATER FOR 30 DAYS |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 16 – 60 years irrespective of gender religion and socioeconomic status will be selected
Patients presenting with clinical features of Ardhavabhedaka will be selected |
|
| ExclusionCriteria |
| Details |
Patients having other types of Shirashula apart from Ardhavabhedaka will be excluded.
Patients suffering from secondary headaches like sinusitis, meningitis etc. will be excluded.
Patients with any other systemic diseases and pregnancy will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bheda Todavat Shula( Intensity of pain)
Duration of single episode
Frequency of attack
Photophobia
Nausea
Vomiting
|
90 DAYS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APLICABLE |
NOT APLICABLE |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/06/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a randomised open label single centre trial comparing the efficacy of Nimbadi guggulu and Padhyadi ghanavati for 30 days in 40 patients with migraineheadache will be conducted in Alvas ayurveda medical college Vidyagiri Moodbidri Dakshina kannada INdia. Primaryoutcome measures will be relief from Bheda Todavat Shula( Intensity of pain), Duration of single episode, Frequency of attack,Photophobia, nausea, vomiting in 90 days · · · ·
|