| CTRI Number |
CTRI/2019/07/020392 [Registered on: 29/07/2019] Trial Registered Prospectively |
| Last Modified On: |
25/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to see the effects of Pathyadi Kwatha and Anu Taila Nasya in Patients with
Ardhavabhedaka (Migraine) |
|
Scientific Title of Study
|
Clinical evaluation of Pathyadi Kwatha and Anu Taila Nasya in the management of Ardhavabhedaka (Migraine). |
| Trial Acronym |
Migraine |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srinibash Sahoo |
| Designation |
Research Officer (Ayurveda), Scientist-3 |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi |
| Address |
Advanced Center for Ayurveda in Mental Health and Neuro Sciences (CCRAS),NIMHANS Campus, Hosur Road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995323 |
| Fax |
|
| Email |
srinibash1970@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srinibash Sahoo |
| Designation |
Research Officer(Ayurveda), Scientist-3 |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi |
| Address |
Advanced Center for Ayurveda in Mental Health and Neuro Sciences(CCRAS),NIMHANS Campus, Hosur Road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995323 |
| Fax |
|
| Email |
srinibash1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srinibash Sahoo |
| Designation |
Research Officer(Ayurveda), Scientist-3 |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi |
| Address |
Advanced Center for Ayurveda in Mental Health and Neuro Sciences(CCRAS),NIMHANS Campus, Hosur Road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995323 |
| Fax |
|
| Email |
srinibash1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences Jawahar lal Nehru Bhartiya Chikitsa Evam
Homoeopathy Anusandhan Bhawan 61-65, Institutional Area, Opposite D-Block, Janakpuri, New
Delhi - 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council For Research In Ayurvedic SciencesCCRAS |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan 61 65 Institutional Area
Opposite D Block Janakpuri New Delhi 110058.
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srinibash Sahoo |
Advanced Center for Ayurveda in Mental Health and Neuro Sciences(CCRAS) |
NIMHANS Campus
Hosur Road Bangalore
560029
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
09448941203
srinibash1970@gmail.com |
| Dr Kishor Patel |
Central Ayurveda Research Institute for Cardiovascular Diseases(CCRAS) |
Punjabi Bagh New Delhi 110026
New Delhi
DELHI |
07405403106
kishoreworld007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC ACAMHNS NIMHANS BENGALURU |
Approved |
| IEC CARID PUNJABI BAGH NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G431||Migraine with aura, (2) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Pathyadi Kwatha
Anu Taila |
1) Pathyadi Kwatha- [Ref.-A.F.I, Part-2, Vol.4:15.]
Ingredients- Haritaki, Bibhitaki, Amalaki, Kiratatikta, Haridra, Nimba and Guduchi.
Dose : 50 ml.
Dosage form : Kwatha (Decoction)
Route of Administration : Oral
Time of Administration : Twice a day; before food.
Anupana : Guda
Duration of therapy : 84 days (12 weeks)
(Add 16 times of potable water in 25 g Kvatha churna and boil till it is reduced to 1/8, filter and consume)
2) Anu Taila- Nasya-[Ref.-A.F.I Part 1,Vol.8:1 Page 365,366.]
Dose : 2 drops in each nostril.
Dosage form : Oil.
Route of administration : Nasal oleation (Nasya).
Time of administration : Early morning.
Duration of therapy : 84 days (12 weeks.)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged in between 18 to 60 years.
2. Diagnosed cases of Migraine with aura /without aura as per as per International Headache Society-ICHD-III (International classification of Headache Disorders 3rd version).
3. Patients with up to Grade III on MIDAS Scale.
4. Frequency of headache is > two times in a month.
5. Willing and able to participate for 3 months (consent to be obtained from patients).
|
|
| ExclusionCriteria |
| Details |
1. Patients who were suffering with headache due to space occupying lesions and other secondary reasons.
2. Patients with severe infection and/or clinically significant respiratory, cardiac or haematological disorders.
3. Hypertensive patients who are on β blockers.
4. Patients with uncontrolled Diabetes mellitus (HbA1C>8%).
5. Patients with uncontrolled Hypothyroidism (S.TSH>10mIU/ml).
6. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.4 mg/dl)
7. Alcoholics and/or drug abusers.
8. Known cases of malignancy.
9. Pregnant women or planning to conceive or lactating woman.
10. Patients in whom another investigational drug was used within 3 months prior to entry in this study.
11. Any other condition, which the PI thinks, may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Clinical Efficacy of Pathyadi Kwatha and Anu Taila Nasya in the management of Ardhavabhedaka (Migraine) |
12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Clinical Safety of Pathyadi Kwatha and Anu Taila Nasya in patients suffering with Ardhavabhedaka (Migraine) |
12 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/08/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
It will publish after completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Migraine is a chronic neurological disorder
characterized by headache often unilateral and accompanied by nausea or
vomiting as well as photosensitivity and phonosensitivity. Migraine causes great physical, and emotional
burden and is considered as one of the most disabling disease among all diseases.
The disease is correlated with Ardhavabhedaka. It is considered to be a
tridoshaja Vyadhi. The conventional healthcare system provides temporary relief
in headache within hours. The Ayurvedic Pharmacopeia of
India has laid standards of Ayurvedic formulations appeared in Ayurvedic
Formulary of India. Oral administration of Pathyadi and Anu Taila Nasya are the
formulations commonly used by Ayurvedic physicians in the management of Ardhavabhedaka
and the pharmacopeial standards are available for both these formulations.
Anu Taila Nasya has been taken as Nasya is considered as the remedy for Urdhvajatru gata
Vikara. |