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CTRI Number  CTRI/2025/04/085780 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 25/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the effect of Nasya with Nasapana using Dashamooladi kashaya in the treatment of Vishwachi 
Scientific Title of Study   A RANDOMIZED CONTROLLED CLINICAL STUDY ON THE EFFECT OF NASYA AND NASAPANA WITH DASHAMOOLADI KASHAYA IN THE TREATMENT OF VISHWACHI (CERVICAL RADICULOPATHY) 
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 Shruti Kundaragi 
Designation  Post graduate scholar 
Affiliation  Shri Jagadguru Gavisidheshwar Ayurvedic Medical College Koppal 
Address  Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Gavimath Campus Koppal

Koppal
KARNATAKA
583231
India 
Phone  8105378027  
Fax    
Email  shruthikundaragi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Latha L U 
Designation  Associate Professor 
Affiliation  Shri Jagadguru Gavisidheshwar Ayurvedic Medical College Koppal 
Address  Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Gavimath Campus Koppal

Koppal
KARNATAKA
583231
India 
Phone  9980879649  
Fax    
Email  dr.lathalu7@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Latha L U 
Designation  Associate Professor 
Affiliation  Shri Jagadguru Gavisidheshwar Ayurvedic Medical College Koppal 
Address  Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Gavimath Campus Koppal

Koppal
KARNATAKA
583231
India 
Phone  9980879649  
Fax    
Email  dr.lathalu7@gmail.com  
 
Source of Monetary or Material Support  
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital, Koppal, Karnataka, India - 583231 
 
Primary Sponsor  
Name  Dr Shruti Kundaragi 
Address  Department of Panchakarma , Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Gavimath Campus, Koppal, Karnataka, India - 583231 
Type of Sponsor  Other [Self] 
 
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 Shruti Kundaragi  Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College, Koppal  Panchakarma Unit, Department of Panchakarma, Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Gavimath Campus , Koppal, Karnataka, India - 583231
Koppal
KARNATAKA 
8105378027

shruthikundaragi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G563||Lesion of radial nerve. Ayurveda Condition: VISVACI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: R H Singh, foreword by Prof P V Sharma; Panchakarma therapy, chowkhamba publication Varanasi, Reprint on 2014, page no 139, Procedure details: I. NASYA Materials required – Gokarnika, Murchita Tila Taila, Dashamooladi Kashaya. Purva Karma: • Subjects advised to have light food at the evening time (6pm). • Subjects will be advised to remain relaxed, Sthanika Abhyanga to face and affected part will be done with murchita Tila Taila followed by Sthanika Bhashpa sweda, till the appearance of Samyak swinna lakshanas. • Care of the eyes should be taken by covering the eyes with a band of wet cloth. Pradhana Karma: • Subject will made lie comfortably in supine position by tilting his head little lowered by keeping the pillow below the neck. • Then the 8 Bindu of freshly prepared luke warm Dashamooladi Kashaya will be instill into each nostril by keeping the other nostril closed, Nasal secretions were advised to be spitted out. Paschat Karma: • Kavala with Sukhoshna Saindhava Jala. • Special advice will be given to Subjects to avoid exposure to wind, dust, smoke and direct sunlight and to use warm water for drinking or bathing and light food to have.)
(1) Medicine Name: Dashamooladi Kashaya, Reference: 13. Priyavrata sharma, chakradatta, Sanskrit text with English translation,12/24, Varanasi, chaukambha publications, edition 2007,186, Route: Nasal, Dosage Form: Kwatha/Kashaya, Dose: 12(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-nAvanam, नावनम् (Procedure Reference: 15. Naik, shruti &patil, vaidya vasanth. (2022) STANDARDIZATION OF NASAPANA PROCEDURE USING SYRINGE AND NETI POT METHOD IN PATIENTS OF AVABAHUKA, Procedure details: II. NASAPANA Materials required – Jala Neti, Murchita Tila Taila, Dashamooladi Kashaya. Purva Karma: • Patient will be advised to have light food at the evening time (6PM) • Vitals will be monitored. • Sthanika Abhyanga to face and affected part will be done with luke warm Murchita Tila Taila followed by Sthanika Bhashpa sweda till the appearance of Samyak Swinna Lakshanas. Care of the eyes should be taken by closing with a band of wet cloth. Pradhana Karma : • Subject will be asked to stand Comfortably, leaning forward tilting the head to one side. • Subject will be asked to breathe out forcefully in order to sniff the foreign bodies, to avoid nasal obstruction and ease the procedure. • The luke warm freshly prepared Dashamooladi Kashaya will be taken in the Neti Pot. The Pot’s spout will be inserted gently in one nostril of subject. • Subject will be asked to sit on the chair comfortably and Breathe through mouth keeping it open. The freshly prepared Dashamooladi Kashaya will be slowly poured into nostril by tilting the head little lowered and it will be allowed to drink by closing the other nostril. • For this group of patients – Increasing dose i.e Starting from 12ml and increasing 2ml daily till 7th day (24ml dose) for each nostril. • The nose will be dried by bending forward and Kapalabhati. Paschat Karma: • After the procedure , Subjects will be asked to lie supine position for couple of minutes. • Subject will be advised for Kavala with Sukhoshna saindhava jala. • Diet and regimen will be prescribed subsequently. )
(1) Medicine Name: Dashamooladi Kashayam, Reference: 14. Priyavrata sharma, chakradatta, Sanskrit text with English translation, 12/26, Varanasi, chaukambha publications, edition 2007, 186, Route: Nasal, Dosage Form: Kwatha/Kashaya, Dose: 12(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects fit for Nasya and Nasapana procedure.
Subjects presenting with Pratyatma lakshana of vishwachi.
Subjects presenting with complaints of Cervical Radiculopathy.
Subjects of either gender aged between 18 to 60 years will be selected.
 
 
ExclusionCriteria 
Details  Subjects unfit for Nasya and Nasapana except Bhuktabhakta.
Subjects having grade 3 adenoids , Grade 3 Deviated nasal septum, Grade 3 turbinate hypertrophy, grade 3 nasal polyp, Acute rhinitis,, concha bullosa etc. which hinders in smooth performance of Nasya and Nasapana.
Subjects having non communicable diseases (NCD) such as uncontrolled diabetes and Hypertension.
Subjects with Fracture of Cervical spine.
Pregnant and lactating women.
Post operated case of Cervical Radiculopathy. 
 
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 
Reduce Pain and Increase range of movement in Cervical Radiculopathy  Total treatment Duration - 7 Days for both the groups.
Follow-up Duration - 14 days for both the groups.
Total Study Duration - 21 days for both the groups.
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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 4 
Date of First Enrollment (India)   07/05/2025 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

We are living in a world of bullet trains, AI (Artificial intelligence), and automation, where everything around is moving fast. Today’s lifestyle has led to various disease conditions that don’t necessarily cause death, but can significantly disrupt day to day life. One  such condition is Vishwachi, affecting upper limbs.
It is one of the most common type of Vata vyadhi found in clinical practice, in which the Prakupita vata affects the Kandara of Bahu, it is a disorder typically occurs during the most active years of life, characterized by Teevra ruja, Ruk, Stamba, Toda, Karmakshaya, Bahu cheshtapaharana.  Pratyatma lakshana of Vishwachi is radiating pain from the Bahu Prishta to the Hastathalam and Pratyanguli,  Acharya Dalhana opines that this condition is similar to Gridhrasi and has two types – Vataja and Vatakaphaja. Being a Shoola pradhana vataja nanatmaja vyadhi, it deprives the patient’s ability to perform movements of upper limb which in turn makes them unable to carry their routine work.
In Allopathy medicine, this condition can be correlated to Cervical Radiculopathy, Cervical radiculopathy is a neurologic    condition    characterized    by dysfunction of a cervical spinal nerve, the roots   of   the   nerve,   or   both.   It   usually presents with pain in the neck and one arm, with a combination of sensory loss, loss of motor  function,  or  reflex changes  in  the affected  nerve-root  distribution. It is associated with movement impairment of the upper limbs in 68% of the cases, scapular pain in 52.5% of cases, paraesthesia in 45.5% of the cases, among others. It’s also associated with diminish Musculoskeletal reflexes. The most common cause of Cervical Radiculopathy is the result of degenerative changes that affect the anatomy of the cervical spine including the vertebral bodies, the intra vertebral discs, the facet joints and the ligament component of cervical spine. Cervical radiculopathies occur at an incidence rate of approximately 85 persons per 100,000. The C7 nerve root is most frequently impacted, with more than half of all cases affecting this level. Roughly a quarter of cases involve the C6 nerve root. Nerve roots C1 to C5 and C8 are less impacted. Risk factors for developing radicular disease include manual labour with heavy lifting, driving, or operating vibrating equipment. Chronic smoking history can increase the risk of radiculopathies. The main goal of treatment in this illness is to alleviate pain , hence analgesics, muscle relaxants, and physiotherapy are all administered. People are turning to Ayurveda to discover a better solution for this ailment due to the negative side effects of pain relievers and surgery.
Nasya, an essential part of Panchakarma, has its mesmerizing effect on almost all Urdhwajatrugata vata vyadhis which is already proven by several researches. The hidden element in Nasya, an inevitable therapy leading to another important procedure called Nasapana, an unique contribution given by Acharya chakradatta and has also mentioned in several context by different acharyas. The words "nasyanipeeto", "pibennasyam" are used in the contexts of Nasapana. The lack of extensive literature, standard guidelines on this procedure and dosage of Nasapana has led to its limited practice. however, on the basis of some recent SOP (standard operating procedure) this procedure will be carried out. when Nasya karma is compared  with Nasapana, basic difference is seen with dosage. All preparations are in Kashaya form for Nasapana with large doses compared to Nasya dosage.
Hence when large dose in Kashaya is given, definitely has more residence time for Aushadha dravya and thus there is better nasal drug absorption. Some researches proved that, A slight modification in internal usage in the form of Nasapana can give combined effect of Nasya as well as Pana and may be more beneficial by cut shorting the time and frequency of multiple medicament administration i.e Nasya along with conservative medicine usage. This single procedure can save the time as well as it may gives more benefits than Nasya or Pana. Hence  an attempt is made to compare the effect of Nasya and Nasapana using Dashamoolaadi kashaya.  Most of the dravyas in Dashamooladi Kashaya has Vatahara and Brihmana Property which can mitigate the  shoola pradhana vataja nanatmaja vyadhi called Vishwachi.

 
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