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CTRI Number  CTRI/2020/04/024487 [Registered on: 07/04/2020] Trial Registered Prospectively
Last Modified On: 03/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic management of Headache 
Scientific Title of Study   Evaluation of the comparative efficacy of Rasnadi Taila Nasya (Standard control) and Dashmoola Taila Nasya (Trial drug) in the management of Vataja Shirahshoola - an open label double arm randomized clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjali Dabas 
Designation  P G Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Shalakya Department, OPD No. 102, First Floor, Hospital Block, All India Institute of Ayurveda, Sarita Vihar, New Delhi

New Delhi
DELHI
110076
India 
Phone    
Fax    
Email  dranjali23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pankaj Kundal 
Designation  Assistant Professor 
Affiliation  All India Institute of Ayurveda 
Address  Shalakya Department, 5th Floor, Administration Block, All India Institute of Ayurveda, Sarita Vihar, New Delhi

New Delhi
DELHI
110076
India 
Phone    
Fax    
Email  drpankajkundal@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pankaj Kundal 
Designation  Assistant Professor 
Affiliation  All India Institute of Ayurveda 
Address  Shalakya Department, 5th Floor, Administration Block, All India Institute of Ayurveda, Sarita Vihar, New Delhi

New Delhi
DELHI
110076
India 
Phone    
Fax    
Email  drpankajkundal@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Sarita Vihar, New Delhi -110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Sarita Vihar, New Delhi-110076 
Type of Sponsor  Research institution and hospital 
 
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 Anjali Dabas  All India Institute of Ayurveda  OPD No. 102, First floor, Hospital Block, All India Institute of Ayurveda, Sarita Vihar, New Delhi 110076
South West
DELHI 
9911166668

dranjali23@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: G894||Chronic pain syndrome, (2) ICD-10 Condition: G894||Chronic pain syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dashamoola Taila Nasya  Nasya (nasal administration) of Dashamoola taila (in two sittings, each for seven days, with a gap of 7 days in between the two sittings of nasya) alongwith oral administration of Dashamoola Kvatha (20 ml twice a day at 7.00 am in the morning and 7.00 pm in the evening for 30 days)will be advised. 
Intervention  Rasnadi Taila Nasya  Nasya (nasal administration) of Rasnadi taila (in two sittings, each for seven days, with a gap of 7 days in between the two sittings of nasya) alongwith oral administration of Dashamoola Kvatha (20 ml twice a day at 7.00 am in the morning and 7.00 pm in the evening for 30 days)will be advised. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients having the signs and symptoms of Vatika Shirahshoola as given in Ayurvedic classics will be selected.
Patients should be willing to participate in the trial.  
 
ExclusionCriteria 
Details  1. Patients not having vatika shirahshoola.
2. Age less than 15 and greater than 50 years.
3. Pregnant and lactating women.
4.Patients suffering from major systemic diseases viz. T.B., cancer, diabetes mellitus, heart diseases, hypertension.
5. Headache due to refractive error and increased intra-ocular pressure.
6. Headache due to involvement of other doshas except vata.
7. Secondary headache due to other pathological conditions e.g. tumors, cerebral haemorrhagic conditions.
8. Traumatic injury.
9. Nasya ayogya patients as per classical texts will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in the signs and symptoms of Vataja Shirahshoola  30 days for oral treatment, two sittings of nasya (7 days in each sitting) 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life   30 days for oral treatment, two sittings of nasya (7 days in each sitting) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   15/04/2020 
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   Findings of the study will be published in reputed journals. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Ayurveda classics have described Shiraha as the supreme part of the body and it is said to be of immense importance. Our ancient sages have described three vital organs in the body and they have given prime importance to the head, as the existence of a body depends upon all the vital organs, and primarily, on the head. Shiraha is that part of the body where life along with all the five senses resides. Shiraha is the site of prana, all the vital stuff supported by prana and all the senses. It has been described that Sirah is the most important of all the body parts. Further, it has been told that, out of the total 107 marmas present in the body, 37 marmas are present in urdhvjatru parts.Therefore, all the shirorogas should be treated at the earliest and with care, because, if untreated, then, it may lead to grievous after-effects.

It has also been emphasized that in a foetus, development of the head occurs at the first, as it is the site of all the important faculties of the human body.

Ayurveda has eight main branches, out of which, Shalakya Tantra also called as Urdhwanga Chikitsa is the branch which deals with the diseases of head, neck, eye, and oro-dentistry.  Diseases of Shirah and their management is dealt in Shalakya Tantra which is one of the eight main branches of Ayurveda.

Shirahshoola is the synonym as well as the symptom of all the Shirorogas described in Ayurveda.

Different types of Shirorogas have been described in all the classics of Ayurveda. Acharya Charak has mentioned that there are 5 types of shirorogas i.e. Vataja, Pittaja, Kaphaja, Sannipataja and Krimija and described the Nidana and Lakshanas of these shirorogas. Further 09 types of Shirahshoola are also described by Acharya Charaka.

Acharya Sushrut has described 11 types of Shirahshoola i.e. Vataja, Pittaja, Kaphaja, Tridosaj, Raktaj, Kshayaj, Krimija, Suryavrat, Anantvata, Ardhavbhedaka and Shankhaka.

Acharya Vagbhatt has described 10 types of Shirahshoola i.e. Vataja, Pittaja, Kaphaja, Raktaja, Tridosaja, Krimija, Sirahkampa, Shankhaka and Suryavrat.

Vataja Shiroroga –

A detailed study of Vataja Shirahshoola has been carried out from Ayurvedic and modern point of view. The references collected were compiled, critically examined and utilized to frame the conceptual part of the study.

        A fit of violent headache without any apparent cause and which becomes worse in the night and is relieved by pressure or by being bandaged or by an application of fomentation around the head is known as the Vataja-Shiroroga.

Contemporary:

Headache is among the most common reasons patients seek medical attention,on a global basis being responsible for more disability than any other neurologic problem. Headache is the common human experience in today’s life, diverse in its expressions, complex in its manifestations and difficult to understand in any simple mechanistic way. Headache causes disturbance and various degree of disability of an individual to deal with daily chores of life. 

          Headache is classified as primary or secondary. A headache is considered primary when it is not caused by any disease or other medical condition. Secondary headaches are caused by various medical conditions, such as sinusitis, neck injuries or abnormalities and stroke, which account for 2% of all headaches.

POSSIBILITIES IN AYURVEDIC TREATMENT FOR SIRAHSHOOLA:

Ayurveda has a variety of natural medication in the treatment of various types of Shirah-roga. All Shirorogas are due to tridosha prakopa and chiefly due to Vata or Vata-KaphaSadhya Shirorogas can be best managed with aushadhis having Ushna, Snigdha properties. Vatahara or Vata-Kaphahara properties. Various internal Rasaushadhis like Shirah-shooladi Vajra Rasa, Laghu Sutashekhara Rasa, and Navjivan Rasa etc. have been mentioned in Bhaisajya Ratnavali, Rasa Tarangini, etc.

Majority of the drugs employed as modern medicine for anxiety type disorders are limited almost to suppress the symptoms. Therefore, search for a safer management from other systems of medicine is of greater interest. Thus a successful clinical trial using an Ayurvedic medicine would certainly be of greater value handling Vatika Shirahshoola.

Ayurveda is such a system of medicine where the importance of both prevention and cure has been highlighted. As per Ayurvedic texts, diseases are deep seated at different dhatu levels. Hence, the procedure Nasya karma is indicated to uproot the deep-seated disease.

In Vataja Shirahshoola, Dashamula Taila Nasya has been indicated in Bhaisajyaratnawali. Dashamula is having Tridoshahara, Shothahara and Shirahshulahara properties. It is capable of curing severe cases of sotha and all types of Shirahshoola.


Further, Acharya Charaka has indicated Rasnadi Taila Nasya in Vataja Shirahshoola. Hence Rasnadi Taila Nasya has been selected from Charaka Samhita.


 
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