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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (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
2Intervention ArmDrugClassical(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: -
 
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 
 
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  -

 â€œCLINICAL 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”.

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).  â€œTypically 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 â€“ 8 weeks

Follow up – 6 MONTHS


 
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