A randomized comparative clinical trial to evaluate the efficacy of nasyaKarma with brihatdashmoola taila and yogic neti karma in the managementOf ardhavbhedaka

INTRODUCTION:

In this present era due to theambitious nature as well as luxurious life of man, it has made man busy all time which leads to disease aggravating cause root factors like stress, strain and mental disturbances. And it’s a real fact that a healthymind is the main cause for a healthybody. And such factors leads to different types of diseases, among which shirorogais one ofthem. All types of shiro shoolahavebeen described under the heading of â€˜Shiroroga’, which are further divided into eleven types according to Sushruta. Ardhavabhedakaone of the important typ e of Shiroroga.

Panchakarmaincludes five main karmaamongwhich Nasyais one of them. Nasyais classified into five types,i.e, Navana, Avapida, Dhmapana, Dhoomaand Pratimarsha. According to acharya Charaka, Nasyaisspecially indicated in Ardhavabhedakaccording to acharya   Charak.   Currently,    conventional    medicine     has    no    effective    treatment for Ardhavabhedaka. But in Ayurveda, Nasya is specially indicated in Ardhavabhedaka.

Jala netiis one among the shatkarmawhichhelps in eliminating the morbit kaphadoshafrom the sinuses. Jala netiis a yogictechnique to cleanyour sinuses and is indicated in shiro roga.

Need of study:

Migraine was identified to be more common in the ruralpopulation, with its prevalence rangingbetween 1.37% and 72%.According to Internationalheadache society, migraine have influence on 16% of the primary headache. In today’s era, 10-20% of general populationsuffer from migraine. It isthree times more common in women than men (3:1) in India morethan 10 million cases per year.

Conventional treatment modalities includes Analgesics and Vasodilators.Classical Ayurvedic texts have describedvarious yogasof Nasyaand also jalanetiin the management of *Ardhavabhedaka,*inwhich Jala netiis much cheaper than nasya karma.Now a days jala netiisnot being clinically practiced regularly .So here is an attempt to compare the efficacy of Brihat Dashamoola taila nasya(GroupA) and Jala Neti(Group B) in the management of Ardhavabhedaka.

REVIEW OF LITERATURE:

ClassicalAyurvedic literature, contemporary texts, journals and website about the disease , drug and procedure will be reviewed documented for the intended study.

RESEARCH QUESTION:

1.      WhetherNasya karma with brihatdasmoola taila 2 bindu in each nostrils for 7days ismore effective than jala-neti karma with lavanodaka for 7 days in management of Ardhavbhedakaa?

AIM AND OBJJECTIVES:

AIM:

“ A RANDOMIZED COMPARATIVE CLINICALTRIAL TO EVALUATE THE EFFICACY OF NASYA KARMAWITH BRIHATDASHMOOLA TAILAAND YOGICNETIKARMAIN THE MANAGEMENT OF ARDHAVBHEDAKAâ€

OBJECTIVES:

1.      To determine the effect of Nasya karma with Brihatdashmoola taila in themanagement of Ardhavbhedaka.

2.       To determine the effects of jala netiin the management of Ardhavbhedaka

3.      To determine the comparative effect of nasya karma with Brihatdashmoola tailand jala netiin the management of Ardhavbhedaka.

Null Hypothesis (H0):

(H0) â€“ Neither Nasya karma with Brihatdashmoola Tailanor Jal-neti effective in management of Ardhavbhedaka.

Alternate Hypothesis:

(H1) â€“ Nasya Karma with Brihatdashmoola tailis more effective than Jal-netiin the managementof Ardhavbhedaka.

(H2) – Jalanetiis more effective than Nasya karma with Brihatdashmoolatailin the managementof Ardhavbhedaka.

(H3) – Both Nasya karmawith Brihatdashmoola tail and Jal-neti areequally effective in the management of Ardhavbhedaka

MATERIALS & METHODS:

1 .Source of data:

i.        Literary source: All the available literature regarding, Arthavabhedaka, Brihatdhamula, Nasya and Jala Neti in classical treatises andcontemporary texts including journals and online sources will be reviewed and documented for the study.

ii.       Pharmaceutical source:

a.       Medicinewill be prepared in the GMP certified Teaching PharmacyofParul Institute of Ayurved.

DRUG SOURCE

1.      Rawdrugs required for preparation of Brihatdashmoola taila will be procured from standard suppliers and identification and authentication of it will be done in   Dravyaguna Department Parul Instituteof Ayurveda.

Brihatdashmoola taila *(*for Pratimarsh Nasya) will be prepared in GMP Certified pharmacy of  Parul Institute of Ayurveda following classical guidelines as mentionedin Bhaishjya ratnavali.

Drugs:

1.     Bilva

2.     Shyonaka

3.     Agnimantha

4.     Gambhari

5.     Patla

6.     Shalparni

7.     Prushniparni

8.     Brihati

9.     Kantakari

10.  Gokshura

11.  Nirgundi swarasa

12.  Adarak swarasa

13.  Taila

14.  Saindhava

15.  Pippali

16.  Chavya

17.  Chitraka

18.  Sunthi

19.  Maricha

20.  Sveta jirak

21.  Krishna jirak

22.  Sarsapa

23.  Nisotha

24.  Haridra

25.  Daruharidra

26.  Yavakshara

Method of collection of data:

A. Sample size:

A minimum of 40 patients diagnosedwith Ardhavbhedaka fulfilling the diagnostic and inclusion criteriairrespective of gender, caste will be randomly selected and grouped into twoi.e. Group A and Group B for the study.

Group A : Nasya with Bhrihatdashmool taila will beadministered on 20 patients for 7 days.

Group B: Jala neti karma will be observed on 20patients for 7 days.

B. Study design:

It is a Randomized Comparative Clinical trial study.

C. Duration of treatment: 7days

D. Follow up:

 Follow up will be after 1st, 7th and 14thday.

E. Selection criteria:

• INCLUSION CRITERIA

• The diagnosis was made based on the criteria ofArdhavabhedaka

• Patients between the age group of 16- 60yrs of age.

• Patients who are fit for “Nasya karmaâ€.

• Patients who are fit for ‘Jal neti’.

• EXCLUSION CRITERIA

• Patient of Ardhavabhedaka who are under othertreatment modalities.

• Patient who are contraindicated for Nasya.

ʉۢ Patients who are contraindicated for Jala Neti.

• Patients suffering from other secondary types ofheadache like in brain tumors, meningitis, cervical-spondylitis, encephalitis,referred pain, refractive errors and glaucoma.

Diagnostic Criteria for Ardhavabhedaka

Subjective parameters

1.     ARDHA SHIRASHOOLA

2.     MANYASHOOLA

3.     BHRAMA

4.     HRILLAS

5.     CHHARDI

6. PRAKASHASHAHISNUTA

7.     SABDAASHAHISNUTA

PLAN OF TREATMENT:

GROUP A-

SOP OF NASYA WITH BHRITDASMOOL TAILA

1. Introduction:

It is a procedure followed in majority of nasaroga, karna roga, netraroga and shiroroga (innirama avastha) etc. in which the liquid medicine is instilled in the nostrils..

2. Requirement:

a)  Manpower- Trained Senior Resident/Junior Resident Doctor,One Class D worker.

b)   Materials-

•  Sterile bowls, sterile dropper Oilfor facial massage Liquid/oil/powdered medicine.

•  Preparation of the table.

3. Pre- operative:

•  Patient made to lie in supine position comfortably with a small pillow under the neck andshoulder maintaining the head low position.

•  Massaging of face, neck and forehead with necessary Oil HotFomentation with steam should be done after massage.

4.   Operative:

The specific medicines is instilled inside the nostrils with the help of dropper.Massaging of face, neck, palm and soles.

The patient is advised to remain in supine position for 100 matrakala (approx. 2.5 min) andspit-out the medicine.

5.   Post-operative:

Gargling with lukewarm water. Inhaling the smoke of dried turmeric.

6.   Safety precautions:

Sterilisation of the materials.

Light food after evacuation of urine and bowel before procedure.

•  Avoidance of exposure to breeze, direct sunrays, smoke and dust. Not to Wash Face with Cold Waterimmediately after the Procedure.Emergency management

•  Theseare very rare in this procedure. Still if happens patient has to inform the trained senior Residentdoctor/junior Resident doctor whois on duty at that particular time. Senior Residentdoctor/junior Resident doctor should inform theConsultant in charge and get the suitable management.

GROUP B

SOP OF JALA NETI:-

1.Neti is a technique to cleanse the nasal passages. It is a cleansing process related to theupper part of the respiratory system.

2.Although authentic references arenot available for jala neti, it is most widely practiced.3.It is usually practiced with a neti pot filled with lukewarm saline water. The exact amount of salt is not mentioned in any traditional texts.

3.  Practically it is about 2.5 gfor 500 L of water. Based on clinical studies use of proper salt concentration (2e3.5%) has been recommended in nasalirrigation .

4.    Some authorsmention about the use of ksheera (milk) and madhu (honey) instead oflukewarm water. It isideally practiced in morning before asanas and pranayama.

5. This is named Neti by the Siddhas.

  PROPHYLACTIC MANAGEMENT

1.    After jala neti KAPAL BHATI should be done .

2.  Now a days 4 size rubber catheter is sterilized and used. Those suffering from chronic nasal bleeding, earinfections and nasal septum deviation should perform under proper guidance

REFERENCES:

1   Charaka Samhita, Dr. Bhramananda tripathi, Vol.1, Chaukhamba Surbharti Prakashan,

 2  Sushruta samhita, Kaviraj Ambikadattashastri, Chaukhamba Sanskrita Sansthan, Varanasi,Reprint-2015, Uttar tantra- 26/31-35

 3  Cakradatta,P. V. Sharma, Published by Chaukhambha Orientalia, Edition-2007, Shiro- rogs,

 4  Yogaratnakarawith Vidyaprabha Hindi Commentary, By Indradev Tripathi and Dr. Daya Shankar Tripathi, ChaukhambaKrishnadas Academy, Varanasi, Shirorogasya upachara-69, Pg.No.-763

 5  Gadanigraha of Sri Vaidya Sodhala, By Sri Indradeva Tripathi, Edited by Sri Ganga Sahaya Pandeya Chaukhambha Sanskrit Sansthana, Reprint-2005,Part-3 Shalakyatantre Shirorogadhikara-1/59.Pg.No.-22

 6  Charaka Samhita By Agnivesa. Edited by Vaidya Jadavaji Trikamji Acharya, Chaukhambha Orientalia, Varanasi, Edition-2009.Sutra sthana-4/18.

7   Hath yog pradipika à¥¨/३०

8  BhaisajyaRatnavali Of Shri Govi nd Dasji; Commented Upon By Shri Kaviraja Ambikadatta Shastri ,Ayurvedacharya Vol-3 ,shiroroga, PageNO-326.