| CTRI Number |
CTRI/2024/05/067428 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Ardhavabhedaka (Migraine) through Pathyadi Kwath along with Rasnadi Taila Nasya. |
|
Scientific Title of Study
|
Clinical study to evaluate the efficacy of Pathyadi Kwath along with Rasnadi taila Nasya as described in Ayurveda Samhitas in the management of Ardhavabhedaka w.s.r to Migraine. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pritesh Sahu |
| Designation |
MD Scholar |
| Affiliation |
Govt. Auto. Ayurveda College and Hospital, Nipaniya Rewa |
| Address |
Dept. Of Samhita Siddhant Govt. Auto. Ayurveda College and Hospital Nipaniya Rewa M.P
Rewa MADHYA PRADESH 486001 India |
| Phone |
7869489249 |
| Fax |
|
| Email |
priteshsahu46@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S.N Tiwari |
| Designation |
Associate Professor |
| Affiliation |
Govt. Auto. Ayurveda College and Hospital Nipaniya Rewa |
| Address |
Dept. Of Samhita Siddhant Govt. Auto. Ayurveda College and Hospital Nipaniya Rewa M.P
Rewa MADHYA PRADESH 486001 India |
| Phone |
7581808285 |
| Fax |
|
| Email |
drsntiwari9@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr O P Shukla |
| Designation |
Assistant Professor |
| Affiliation |
Govt. Auto. Ayurveda College and Hospital Nipaniya Rewa |
| Address |
Dept. of Samhita Siddhant Govt. Auto. Ayurveda College and Hospital Nipaniya Rewa
Rewa MADHYA PRADESH 486001 India |
| Phone |
8435531513 |
| Fax |
|
| Email |
omhprakash2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Auto. Ayurveda College and Hospital Nipaniya Rewa |
|
|
Primary Sponsor
|
| Name |
Govt Auto Ayurveda College and Hospital Nipaniya Rewa |
| Address |
Dept. of Samhita Siddhant Govt. Auto. Ayurveda College and Hospital Nipaniya Rewa |
| 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 Pritesh Sahu |
Govt. Auto. Ayurveda College and Hospital Nipaniya Rewa M.P |
Room No. 19 Dept. of Samhita Siddhant Rewa Rewa MADHYA PRADESH |
7869489249
priteshsahu46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt. Auto. Ayurveda College and Hospital Nipaniya Rewa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: Charak.siddhi. 9/89, Procedure details: 2 drops in each nostrils) (1) Medicine Name: Rasnadi taila, Reference: Charak.chikitsa.26/160, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Duration: 8 Weeks | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathyadi kwath, Reference: Sharangdhar samhita M.kh 2/143-145, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: - Jaggery), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with signs and symptoms of Ardhavabhedaka according to the Ayurveda Classics and Modern text.
2.Patient who fulfill under the Diagnostic criteria.
3.Patients suitable for Nasya Karma.
4.Patients who have given written consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients having referred pain in one half of head due to pathology of eye, ear, nose, throat, teeth will be excluded.
2. Patients having any other systemic pathology like renal failure, TB, heart disease etc will be excluded.
3. Head Injury.
4. Headache due to Benign/Malignant growth.
5. Lactating and Pregnant women.
6. Patients who are not willing to written consent to participate in the study.
7. Chakshurindriya / Shrotrendriya Vinasha Patients.
8. DM |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective parameters like headache, vertigo, nausea, vomiting, photophobia, phonophobia |
from 0 days to 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of trial drugs in improving the signs, symptoms as per assessment criteria & HIT-6 test. |
After 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE - “CLINICAL STUDY TO
EVALUATE THE EFFICACY OF PATHYADI KWATH ALONG WITH RASNADI TAILA
NASYA AS DESCRIBED IN AYURVEDA SAMHITAS IN THE MANAGEMENT OF ARDHAVABHEDAKA
W.S.R. TO MIGRAINEâ€. AIMS & OBJECTIVE - · To
evaluate the efficacy of Pathyadi kwath and Rasnadi Taila Nasya in the management of Ardhavabhedaka
( Migraine).
To assess the effect of trial
drugs in improving the signs, symptoms as per assessment criteria and HIT-6
Test. INTRODUCTION :-
Our
ancient sages have described three vital organs and have given prime importance
to head i.e., Shirah, as the existence of body depends upon the vital organ.Shirah
is that part of the body where life along with sense faculties resides.
Almost
all our ancient Acharayas have mentioned about the Shiro-roga of which
Shirah-shoola as the main symptom and also they have taken Shirah-shoola as the
synonym of Shiro-roga. Ardhavabhedaka is a Shiroroga mentioned in various texts
of Ayurveda. Some Acharyas has been classified as Vataja, Vatakaphaja and
Tridoshajaroga. Ardhavabhedaka
etiology and symptoms are most appropriately related to migraine hence it can
be co-related with Migraine headache of Modern medicine. Migraine being a primary headache, affects one in
seven globally and is
the second most common type of
neurovascular headaches. It is the third most common disease in the world
characterized by recurrent headaches that are moderate to severe and seventh highest specific cause of disability
worldwide (GBD 2012). “Typically in Migraine, the headaches affect
one half of the head, are pulsating in nature, and last from 4 to 72 hours.
Associated symptoms may include nausea, vomiting, and sensitivity to light,
sound, or smell.†NEED OF THE STUDY:-
Ø In Present Scenario the incidence of migraine is
increasing day by day. It affects the personal, social, and economic life of a
person.
Ø Person wants
instant relief in migraine.
Ø In Modern Medical Science, there is only symptomatic
treatment of migraine, for example NSAIDS group, Beta blocker, anti-seizure,
antidepressant, calcium channel blocker etc. and long-term use of these drugs
can lead to stomach ulcers, hepatotoxic, renal problem, decreased heart
function, asthma and many more.
Ø So, to get out
of these problems we need Alternative approach of management.
Study Design :-
Study Type : Interventional
Purpose : Treatment
Masking : Open
Labelled, Clinical trial
Direction : Prospective
End point : Efficacy
No. of Groups : Single
Group
Sample size : 30 Patients Probable Mode of Action of Drug :-
Ø Pathyadi
Kwath is tikta kashaya rasa pradhana, having madhur vipaka and ushna veerya
with laghu & ruksha guna predominance.
Ø Practically
most of the patients with migraine are seen having hyperacidity, history of
consumption of street food, spicy food, night out, stressful lifestyle these
are described as pitta prakopaka hetus in Ayurveda, which are responsible for
nausea, vomiting, vertigo.
Ø So
considering pitta predominance in Ardhavabhedaka tikta kashaya and madhur vipaka
of Pathyadi kwath will be best pittashamaka dravya.
Ø Katu
and tikta rasa of pathyadi kwath have deepana, pachana karma that helps to
improve metabolism by the property of Amapachana.
Ø Ushna
veerya of pathyadi kawth act as stroto shodhaka and kleda shoshaka; eliminate
morbid doshas accumulated in the body.
Ø Though
the percentage of ushna veerya dravya are 57% it is not that high to cause
pitta prakopa rather it balances associated kaphadosh in Ardhavabhedaka.
Ø In
addition, laghu and ruksha guna act as kleda shoshaka, mala of kapha dosh.
Ø Nasya aushadhi reaches to brain via nasal route and acts on higher
centers of brain controlling
different neurological, endocrinal
and circulatory functions and
thus showing local
as well as systemic
effects.
All we can say pathaydi kwath and nasya can
break the samprapti of Ardhavebhedaka. TREATMENT REGIMEN :-
|
PROCEDURE
|
DURATION
|
DRUGS
|
DOSE
|
TIME
|
|
Pratimarsh
nasya
|
8 weeks
|
Rasnadi
Taila
|
2 Bindu
In each nostril
|
Morning-
Evening
|
|
Shaman
Aushadh
|
8 weeks
|
Pathyadi
Kwath
|
40 ml
Twice a
day
|
Before meal
|
Duration – 8 weeks Follow up – 6 MONTHS
|