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CTRI Number  CTRI/2023/05/052452 [Registered on: 10/05/2023] Trial Registered Prospectively
Last Modified On: 09/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Vataja Shiroshoolas management as a result of Anutaila Pratimarsha Nasya. 
Scientific Title of Study   Effect of Anutaila Pratimarsha Nasya in the management of Vataja Shiroshoola 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepika Das 
Designation  M D Scholar 
Affiliation  Shri Narayan Prasad Awasthi Govt Ayurved College Raipur Chhattisgarh 
Address  Shri Narayan Prasad Awasthi Government Ayurved College G E Road Raipur Chhattisgarh 492010

Raipur
CHHATTISGARH
492010
India 
Phone  8770231735  
Fax    
Email  dr.deepikadas10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sasmita Tripathy 
Designation  Reader 
Affiliation  Shri Narayan Prasad Awasthi Govt Ayurved College Raipur Chhattisgarh 
Address  Shri Narayan Prasad Awasthi Government Ayurved College G E Road Raipur Chhattisgarh 492010

Raipur
CHHATTISGARH
492010
India 
Phone  8763650383  
Fax    
Email  sasmita1980@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepika Das 
Designation  M D Scholar 
Affiliation  Shri Narayan Prasad Awasthi Govt Ayurved College Raipur Chhattisgarh 
Address  Shri Narayan Prasad Awasthi Government Ayurved College G E Road Raipur Chhattisgarh 492010

Raipur
CHHATTISGARH
492010
India 
Phone  8770231735  
Fax    
Email  dr.deepikadas10@gmail.com  
 
Source of Monetary or Material Support  
Department of Swasthavritta And Yoga Shri Narayan Prasad Awasthi Government Ayurved College G E Road Raipur Chhattisgarh 
 
Primary Sponsor  
Name  Department of Swasthavritta And Yoga 
Address  Department of Swasthavritta And Yoga Shri Narayan Prasad Awasthi Government Ayurved College G E Road Raipur Chhattisgarh 
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 Deepika Das  Shri Khudadad Dungaji Government Ayurved Hospital Raipur Chhattisgarh  OPD No 6 Department of Swasthavrtta And Yoga Shri Khudadad Dungaji Goverment Ayurved Hospital G E Road Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH 		 8770231735

dr.deepikadas10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: SIROROGAH/SIRAHSULA/SIRASTAPA/SIROBITAPA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Anutaila, Reference: Ashtanga Hridayam, Route: Nasal, Dosage Form: Taila, Dose: 5(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -5 drops of Anutaila is give in both Nostril twice daily before food.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. The patient age between 20 to 60 year irrespective of their gender, cast, religion, occupation and financial status.
2. Patient having symptoms described in Ayurveda and modern literature.
3. Patient willing for the study. 
 
ExclusionCriteria 
Details  1. Head Injury, Known case of Meningitis ,Encephalitis, Cerebral Abscess, Hypertension ,Intracranial Tumor, AIDS, Chronic Sinusitis, Acute Rhinitis, Cerebral Hemorrhagic condition.
2. Nasya Ayogya as per classical texts.
3. During pregnancy.
4. The women who has given birth recently.
5. Patient of dyspnea and cough.
6. Patient not willing for the study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Anutaila Pratimarsha Nasya will be effective on Vataja Shiroshoola.  15 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Symptoms of Shankhanistoda, Ghatasambheda, Bhrumadhya Evam Lalatatapana, Shrotranishkasanvatpida, Akshi Nishkasanavat Pida, Shiroghurna, Sandhi Mokshanvata Pida, Sirajaal Sphurana, Nisha kale Ativedana, Nidranasha are reduced.  30 Days 
 
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 1/ Phase 2 
Date of First Enrollment (India)   20/05/2023 
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  
INTRODUCTION :- 
The term Ayurveda means “Science of life”. It is not only a Healing Science, but a guide to live an ideal and healthy lifestyle for every human being in this universe. This can be achieved by means of preventive disease, preserving and promoting health[1].
Head or Shirah is considered to be the most important organ of the body. Where all the sence organ are present ,and where Prana (life activity) is centralized and chief among all the parts of the body , should be zealously protected[2].
The sages have known that man is like a tree having his roots above and branches below, hence disease which destroy the roots should be won over (cured )quickly[3].
In Ayurvedic literature almost all Acharyas have described the Shiroroga and Shiroshoola is most common Feature in Shiroroga as per various types of Shiroroga all the Three Dodhas are able to produce various types of Shiroshoola. Amongest them Vataja Shiroshoola is most frequently available because causative factors like Uchcha and Atibhashana, Prajagara, Shita Marutasamsparsha, Vyavayadhika, Veganigraha, Upvasa, Atibharvahana and Atimargavahana are usually adopted by all human beings do to their busy lifestyle[4].
Nasya is the best solution for these problem or avoids these disease. Nasya is classified in various ways by Different Ayurvedic literatures, Pratimarsha Nasya is one of Important type among them. Pratimrasha Nasya is a special type of Snehana Nasya with low dose and minimal complications, It can be administered daily and even in all the season. It is given by dipping the finger in the required Sneha then dropping it in each nostril.
Astang Hridaya mentioned that Anutaila is best use for Nasya Karma. Anutaila is having property of Mahagunam[5].

NEED OF STUDY :-
Approximately 75% to 90% of all persons who complain of chronic or frequent headaches suffers from tension headache. Tension type headache is the most prevalent neurological disorder world wide with over 2 billion suffering from this headache. This is ranked as the second most common cause of chronic disease and injury globally[6].
In this competitive era, it is big challenge for a person to maintain healthy life because changes in lifestyles which includes irregular faulty dietary pattern, suppression of natural urges ,sleepless nights, continuously work on computer , mental stress etc. consequently the man has become victim of challenging disease like tension headache.
For the management of the disease analgesics, NSAIDs, opioid derivatives, drugs are used in modern medicine. but these drugs cause severe adverse effects like, gastric irritation, drug resistance, drug dependence ,fluctuation of mood, so safe and effective remedy is the need of this time.
Now a days globally a large section of population is looking towards natural way of life and they have lot of expectation from Ayurveda, hence to avoid the adverse effects, afforts have been made to develop an approach which is safe, effective and cost effective treatment modality for the management of the disease Vataja Shiroshoola. Nasya karma is a part of Dincharya where the medicated oil, Kwath, Swarsa, Churna, etc are administered through nose to eliminate the vitiated Dosha situated in Shira for the treatment of Urdhavajatrugatavikara.
The quotation “Nasa hi shirasodwaram” itself explain its importance and it is the only karma which is explained in Dinacharya[7].
 
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