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 Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Relief in the signs and symptoms of Vataja Shirahshoola
Study Overview
Brief Summary
Ayurveda classics have described Shiraha as the supreme part of thebody 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 Sushruthas described11 types of Shirahshoola i.e. Vataja, Pittaja, Kaphaja, Tridosaj, Raktaj, Kshayaj, Krimija, Suryavrat, Anantvata, Ardhavbhedaka and Shankhaka.
Acharya Vagbhatthas described10 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-Kapha. Sadhya 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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 15.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients not having vatika shirahshoola.
- •Age less than 15 and greater than 50 years.
- •Pregnant and lactating women.
- •4.Patients suffering from major systemic diseases viz.
- •T.B., cancer, diabetes mellitus, heart diseases, hypertension.
- •Headache due to refractive error and increased intra-ocular pressure.
- •Secondary headache due to other pathological conditions e.g. tumors, cerebral haemorrhagic conditions.
- •Traumatic injury.
- •Nasya ayogya patients as per classical texts will be excluded.
Outcomes
Primary Outcomes
Relief in the signs and symptoms of Vataja Shirahshoola
Time Frame: 30 days for oral treatment, two sittings of nasya (7 days in each sitting)
Secondary Outcomes
- Improvement in quality of life(30 days for oral treatment, two sittings of nasya (7 days in each sitting))
