| CTRI Number |
CTRI/2017/02/007845 [Registered on: 13/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
MANAGEMENT OF ARDHAVABHEDAKA (MIGRAINE) WITH AGNIKARMA AND PATHYADI KWATHA - A COMPARATIVE STUDY |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY OF AGNIKARMA AND PATHYADI KWATHA 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 |
Dr Brinda Kanakhara |
| Designation |
PG Scholar |
| Affiliation |
Government Akhandanand Ayurveda College |
| Address |
c/o Dr. M. N. Kanakhara,
Accident & Ortho. hospital,
beside S. T. Stand,
Palitana
OPD of Department of Shalakyatantra
Govt. Akhandanand Ayurveda College,
Bhadra,
Ahmedabad - 380001
Ahmadabad
GUJARAT
364270
India |
| Phone |
9408966840 |
| Fax |
|
| Email |
bmk1490@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VARSHABEN CHAUDHARI |
| Designation |
PH.D., M.S. AYU |
| Affiliation |
GOVT. AKHANDANAND AYURVEDA COLLEGE |
| Address |
Lecturer,
Upgraded Department of Shalakya Tantra,
Government Akhandanand Ayurveda College
Ahmadabad
GUJARAT
380001
India |
| Phone |
9328083435 |
| Fax |
|
| Email |
ashavarsha_tarak@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR VARSHABEN CHAUDHARI |
| Designation |
PH.D., M.S. AYU |
| Affiliation |
GOVT. AKHANDANAND AYURVEDA COLLEGE |
| Address |
Lecturer,
Upgraded Department of Shalakya Tantra,
Government Akhandanand Ayurveda College
Ahmadabad
GUJARAT
380001
India |
| Phone |
9328083435 |
| Fax |
|
| Email |
ashavarsha_tarak@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurveda College, Ahmedabad |
| Smt. Maniben Government Ayurvedic Hospital,
Asarva, Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Govt Akhandanand Ayurveda Hospital and Smt Maniben Ayurvedic Hospital |
| Address |
OPD Shalakya tantra
Govt Akhandanand Ayurveda Hospital,Bhadra and Maniben Ayurvedic Hospital, Asarva, Ahmedabad |
| 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 Brinda Kanakhara |
Government Akhandanand Ayurveda Hospital |
OPD OF SHALAKYATANTRA DEPARTMENT,
Govt. Akhandanand Ayurveda Hospital,
Bhadra,
Ahmedabad - 1
Ahmadabad
GUJARAT |
9408966840
bmk1490@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Ardhavbhedaka (MIGRAINE), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agnikarma (Therapeutic Burn) |
Agnikarma (Therapeutic Burn), one spot will be done on affected side temporal region on face of patient one in a week for 4 weeks along with 280 gms of Pathyadi Kwatha for a week. pathyadi kwatha will be given for 4 weeks.
Total number of patient will be minimum 15 registered patient in this group. |
| Comparator Agent |
Pathyadi kwatha |
Pathyadi Kwatha - 280 gms of Pathyadi Kwatha will be given for a week. Total duration will be of 4 weeks.
Total number of patient will be minimum 15 registered patient in this group. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical picture of Ardhavabhedaka [Migraine] will be selected irrespective of Sex, Religion and Profession. |
|
| ExclusionCriteria |
| Details |
i. Patient who are not eligible for Agnikarma as per Ayurvedic Texts.
ii. Age < 16 years and > 70 years.
iii. Referred pain in one half of the head due to disorder of Eye, Ear, Nose, Throat, Teeth etc. will be excluded
iv. Patient having Migraine except Migraine without Aura like Migraine with aura, Familial Hemiplegic Migraine (FHM), Complicated Migraine etc.
v. Patient suffering from Diabetes, Tuberculosis, Hypertension, Malignancy and/or any other General Debilitating Health condition.
vi. Patient who need surgical and intervention (Polyp etc.)
vii. Patient on any other medications which is interfering with trial treatment.
viii. Patients, not willing to be registered for trial. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in headache of migraine |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in duration of onset and severity of pain in migraine headache |
30 days
45 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2016 |
| Date of Study Completion (India) |
30/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
A pilot study on clinical efficacy of Agnikarma and Pathyadi
decoction (an Ayurvedic formulation) in the management of
Ardhavabhedaka (migraine) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a randomized, parallel group trial in Department of Shalakyatantra OPD at Government Akhandanand Ayurveda College and hospital, Ahmedabad, Gujarat. Dealing with patients of Ardhavabhedaka(Migraine) and its treatment. Acharya Charaka has given Agnikarma as a treatment for Ardhavabhedaka as in his opinion Ardhavabhedaka is due to vitiated vata-kapha and Acharya Sushruta has discribed agnikarma as quick pain relief and stopping the recurrence of a disease. Therefore in the present study Agnikarma along with Pathyadi Kwatha (Orally) have been selected for clinical trials in group A. Pathyadi Kwatha (Orally) has been selected for clinical trials in group P. METHODS: in group A, Agnikarma will be done on effected temporal site of Face once in a week for 4 weeks and pathyadi kwatha will be given orally in dose of 40 ml twice in a day for 30 days. in group P, pathyadi kwatha will be given in same dose and duration as group A. CONCLUSION On analysing overall effect of therapies in both the group, in Group A, 2 (14.3%) patient were cured, 11 (78.6%) patients were Markedly Improved, and 1 (7.14%) patient was Moderately Improved.  On analysing overall effect of therapies in Group P, 1 (7.14%) patient was cured while 13 (92.9%) patients were Markedly Improved. clinically Agnikarma and Pathyadi Kwatha combine work better to manage the Ardhavabhedaka (Migraine). |