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CTRI Number  CTRI/2023/06/054576 [Registered on: 30/06/2023] Trial Registered Prospectively
Last Modified On: 29/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between Nasya(Nasal drop) with Bhrihat Dashmoola taila and Jalneti for the treatment of Migraine( Headache). 
Scientific Title of Study   A randomized comparative clinical trial to evaluate the efficacy of nasya Karma with brihatdashmoola taila and yogic neti karma in the management Of ardhavbhedaka 
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 Ajeet Sharma 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved 
Address  OPD No 105 Department of Panchkarma OPD No 105 Department of Panchkarma Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  8619084510  
Fax  02668-260201  
Email  ajeetsharma130695@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mahesh M Parappagoudra 
Designation  Associate professor 
Affiliation  Parul Institute of Ayurved 
Address  Panchakarma-OPD No.105 and IPD, Parul Ayurved Hospital, Parul University, Limda, Tal. Waghodia-391760, Dist-Vadodara, GUJARAT. 391760 India

Vadodara
GUJARAT
391760
India 
Phone  9880988563  
Fax  02668-260201  
Email  mahesh.parappagoudra26812@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Mahesh M parappagoudra 
Designation  Associate Professor 
Affiliation  Parul Institute of Ayurved 
Address  Panchakarma-OPD No.105 and IPD, Parul Ayurved Hospital, Parul University, Limda, Tal. Waghodia-391760, Dist-Vadodara, GUJARAT. 391760 India

Vadodara
GUJARAT
391760
India 
Phone  9880988563  
Fax  02668-260201  
Email  mahesh.parappagoudra26812@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Panchakarma OPD and IPD, Parul Ayurved Hospital, Parul University Limda, Vadodara, Gujarat (391760) 
 
Primary Sponsor  
Name  Parul Ayurved Hospital 
Address  Panchakarma - OPD no 105 and IPD, Parul Ayurved Hospital, Parul University, Limda, Vadodara, Gujarat, Pin no - 391760  
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 
Ajeet Sharma  Parul Ayurved Hospital  Panchakarma - OPD no 105 and IPD, Parul Ayurved Hospital, Parul University, Limda, Vadodara, Gujarat, Pin no - 391760 Vadodara GUJARAT
Vadodara
GUJARAT 
8619084510
02668-260201
ajeetsharma130695@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE(IEC),PARUL INSTITUTE OF AYURVED,PARUL UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G438||Other migraine. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: Yogic Neti karma- once a day for 7 days, Ritucarya: avoid cold water and avoid food before procedure and half an hour after procedure, Acara Rasayana:procedure to be done on empty stomach in morning, Other:after procedure, kapal bhati should be done, Pathya/Apathya:yes, Pathya:light, easy digestable foods should be taken, Apathya:avoid direct wind avoid oily, spicy food.
2Comparator ArmProcedure-nAvanam, नावनम् (Procedure Reference: (Procedure Reference: Charak Sidhi Sthana 9th chapter 74 to 78 verse ), Procedure details: Procedure details: Brihat Dashmoola Taila is instilled inside the nostrils with the help of dropper. Massaging of face, neck, palm & soles.The patient is advised to remain in supine position for 100 matrakala (approx. 2.5 min).))
(1) Medicine Name: bhrihardashmool taia, Reference: 8 Bhaisajya Ratnavali Of Shri Govi nd Dasji; Commented Upon By Shri Kaviraja Ambikadatta Shastri ,Ayurvedacharya Vol-3 ,shiroroga, Page NO-326., Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The diagnosis was made based on the criteria of Ardhavabhedaka .
• Patients between the age group of 16- 60yrs of age.
• Patients who are fit for “Nasya karma”.
• Patients who are fit for ‘Jal neti’.  
 
ExclusionCriteria 
Details  Patient of Ardhavabhedaka who are under other treatment modalities.
• Patient who are contraindicated for Nasya.
• Patients who are contraindicated for Jala Neti.
• Patients suffering from other secondary types of headache like in brain tumors,
meningitis, cervical-spondylitis, encephalitis, referred pain, refractive errors and
glaucoma.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in following symptoms-
Unilateral headache
Cervical pain
Vertigo
Nausea
Vomiting
Photophobia
Phonophobia 
Treatment time period- 7 days
follow up- 8th day and 14th day 
 
Secondary Outcome  
Outcome  TimePoints 
There will be increased quality of life in ardhavbhedaka
patients & complications of the disease will be
reduced.  
25 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   12/07/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  


INTRODUCTION:

In this present era due to the ambitious 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 healthy mind is the main cause for a healthy body. And such factors leads to different types of diseases, among which shiro roga is one of them. All types of shiro shoola have been described under the heading of â€˜Shiroroga’, which are further divided into eleven types according to Sushruta . Ardhavabhedaka one of the important typ e of Shiroroga.

Panchakarma includes five main karma among which Nasya is one of them. Nasya is classified into five types,i.e, Navana, Avapida, Dhmapana, Dhooma and Pratimarsha. According to acharya Charaka, Nasya is specially indicated in Ardhavabhedak according to acharya   Charak.   Currently,    conventional    medicine     has    no    effective    treatment for Ardhavabhedaka. But in Ayurveda, Nasya is specially indicated in Ardhavabhedaka.

Jala neti is one among the shatkarma which helps in eliminating the morbit kapha dosha from the sinuses . Jala neti is a yogic technique to clean your sinuses and is indicated in shiro roga.

Need of study:

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

Conventional treatment modalities includes Analgesics and Vasodilators.Classical Ayurvedic texts have described various yogas of Nasya and also jala neti in the management of Ardhavabhedaka, in which Jala neti is much cheaper than nasya karma. Now a days jala neti is not being clinically practiced regularly .So here is an attempt to compare the efficacy of Brihat Dashamoola taila nasya (Group A) and Jala Neti(Group B) in the management of Ardhavabhedaka.

REVIEW OF LITERATURE:

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

RESEARCH QUESTION:

1.      Whether Nasya 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 CLINICAL TRIAL TO EVALUATE THE EFFICACY OF NASYA KARMA WITH BRIHATDASHMOOLA TAILA AND YOGIC NETIKARMA IN THE MANAGEMENT OF ARDHAVBHEDAKA”

OBJECTIVES:

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

2.       To determine the effects of jala neti in the management of Ardhavbhedaka

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

 Null Hypothesis (H0):

(H0) â€“ Neither Nasya karma with Brihatdashmoola Taila nor Jal-neti effective in management of Ardhavbhedaka.

Alternate Hypothesis:

(H1) â€“ Nasya Karma with Brihatdashmoola tail is more effective than Jal-neti in the management of Ardhavbhedaka.

(H2) – Jala neti is more effective than Nasya karma with Brihatdashmoola tail in the management of Ardhavbhedaka.

(H3) – Both Nasya karma with Brihatdashmoola tail and Jal-neti are equally 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 and contemporary texts including journals and online sources will be reviewed and documented for the study.

ii.       Pharmaceutical source:

 a.       Medicine will be prepared in the GMP certified Teaching Pharmacy ofParul Institute of Ayurved.

DRUG SOURCE

1.      Raw drugs 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 Institute of 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 diagnosed with Ardhavbhedaka fulfilling the diagnostic and inclusion criteria irrespective of gender, caste will be randomly selected and grouped into two i.e. Group A and Group B for the study.

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

Group B: Jala neti karma will be observed on 20 patients 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 of Ardhavabhedaka

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

• Patients who are fit for “Nasya karma”.

• Patients who are fit for ‘Jal neti’.

ʉۢ EXCLUSION CRITERIA

• Patient of Ardhavabhedaka who are under other treatment modalities.

• Patient who are contraindicated for Nasya.

 

• Patients who are contraindicated for Jala Neti.

• Patients suffering from other secondary types of headache 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, netra roga 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-

 â€¢  Sterile bowls, sterile dropper Oil for 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 Hot Fomentation 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.

 â€¢  Avoidance of exposure to breeze, direct sunrays, smoke and dust. Not to Wash Face with Cold Water immediately after the Procedure.Emergency management

•  These are very rare in this procedure. Still if happens patient has to inform the trained senior Resident doctor/junior Resident doctor who is on duty at that particular time. Senior Residentdoctor/junior Resident doctor should inform the Consultant 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 are not 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 nasal irrigation .

4.    Some authors mention about the use of ksheera (milk) and madhu (honey) instead oflukewarm water. It is ideally 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, ear infections 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  Yogaratnakara with Vidyaprabha Hindi Commentary, By Indradev Tripathi and Dr. Daya Shankar Tripathi, Chaukhamba Krishnadas 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  Bhaisajya Ratnavali Of Shri Govi nd Dasji; Commented Upon By Shri Kaviraja Ambikadatta Shastri ,Ayurvedacharya Vol-3 ,shiroroga, Page NO-326.


 

 


 
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