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CTRI Number  CTRI/2024/12/077798 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the efficacy of Nasya karma in the management of viÅ›vaÌ„cÄ« (Brachial Neuralgia).  
Scientific Title of Study   A Comparative Clinical Study to evaluate the efficacy of Nasya karma with Mahamasa taila (Niramisa) and Ksheerabala avartana taila in the management of visvaci vata with special reference to Brachial Neuralgia 
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.D. Priyadarshini 
Designation  Post Graduate 
Affiliation  Sri Venkateswara Ayurvedic College and Hospital 
Address  Room no.65 2nd floor, Department of Panchakarma, Sri Venkateswara Ayurvedic College and Hospital SVIMS CAMPUS Tirupati.

Chittoor
ANDHRA PRADESH
517501
India 
Phone  07337426690  
Fax    
Email  darshikapriya21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. K. Harshavardhana Appaji 
Designation  M.D.(Ayu).,FBAA(UK), Panchakarma Professor /Reader(P.G.) 
Affiliation  Sri Venkateswara Ayurvedic College and Hospital 
Address  Room no.65 2nd floor, Department of Panchakarma, Sri Venkateswara Ayurvedic College and Hospital SVIMS CAMPUS Tirupati.

Chittoor
ANDHRA PRADESH
517501
India 
Phone  8099959900  
Fax    
Email  avinas123419@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.K. Harshavardhana Appaji 
Designation  M.D.(Ayu).,FBAA(UK), Panchakarma Professor/Reader(P.G.) 
Affiliation  Sri Venkateswara Ayurvedic College and Hospital 
Address  Room no.65 2nd floor, Department of Panchakarma, Sri Venkateswara Ayurvedic College and Hospital SVIMS CAMPUS Tirupati.

Chittoor
ANDHRA PRADESH
517501
India 
Phone  8099959900  
Fax    
Email  avinas123419@gmail.com  
 
Source of Monetary or Material Support  
Material 
 
Primary Sponsor  
Name  Sri Venkateswara Ayurvedic College and Hospital 
Address  Room no.65 2nd floor, Department of Panchakarma, Sri Venkateswara Ayurvedic College and Hospital SVIMS CAMPUS Tirupati. 
Type of Sponsor  Government medical college 
 
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 
DrD Priyadarshini  Sri Venkateswara Ayurvedic College and Hospital  Room no.65 2nd floor, Department of Panchakarma, Sri Venkateswara Ayurvedic College and Hospital SVIMS CAMPUS Tirupati, 517501
Chittoor
ANDHRA PRADESH 		 07337426690

darshikapriya21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of TTDS Sri Venkateswara Ayurvedic College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G540||Brachial plexus disorders. Ayurveda Condition: VISVACI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: charaka samhitha, Procedure details: nasya karma - it is done about 30min per day for 14 days continuosly.)
(1) Medicine Name: Mahamasha (niramisa) taila and Ksheerabala Avartana Taila, Reference: Bhaiá¹£ajya Ratnavali 26/578-584) and sahasrayogam, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients aged between 20 to 60 years.
2. Patients presenting with the signs and symptoms of viśvācī.
3. Patients presenting with the signs and symptoms of Brachial neuralgia.
4. Patients who are eligible for Nasya karma. 
 
ExclusionCriteria 
Details  1.Patients aged between below 20 and above 60 years.
2.Patients with Uncontrolled Diabetes and Hypertension.
3.Patients with Ankylosing Spondylitis.
4.Patients associated with any other major systemic illness like Tuberculosis, Cancer.
5.Patients who are not eligible for Nasya karma.
6.Patients who are not willing to give the consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacies of Nasya karma with MahāmāṣhaTaila (nirāmiṣā) group and
Ksheerabala avartana taila group in the management of viśvācī (Brachial Neuralgia).
 		 At baseline after after completion of treatment 14th day, 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacies of Nasya karma with MahāmāṣhaTaila (nirāmiṣā) group and
Ksheerabala avartana taila group in the management of viśvācī (Brachial Neuralgia).
 		 At baseline after after completion of treatment 14th day, 4 weeks  
To compare the efficacies of Nasya karma with MahāmāṣhaTaila (nirāmiṣā) group and
Ksheerabala avartana taila group in the management of viśvācī (Brachial Neuralgia).
 		 At baseline after after completion of treatment 14th day, 4 weeks  
 
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   N/A 
Date of First Enrollment (India)   12/12/2024 
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="1"
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  
Brachial neuralgia is a rare disorder affecting the brachial plexus, characterised by severe burning 
pain in the shoulder and upper arm that awakens the patient from sleep accompanied with 
upper arm weakness. Brachial neuralgia presents as an acute brachial plexopathy of probable inflammatory origin. Severe 
shoulder pain precedes the appearance of a patchy upper brachial plexus lesion, with motor and 
sensory involvement. There is no specific treatment and recovery is often incomplete; it may 
reoccur in about 25% and there is a rare autosomal dominant hereditary form. 
It is multifocal, immune-mediated inflammatory process that involves the peripheral nerves. More 
common causes that have been reported in the literature include infection, whether bacterial, 
parasitic or viral. Other conditions that predispose patients to developing brachial neuralgia are 
expose to surgery, an anaesthesia, rheumatic diseases such as connective tissue disorders, systemic 
lupus erythematosus, temporal arteritis, and polyarteritis nodosa. Trauma to the shoulder girdle and 
stressful exercise are other determining factors. 
 
 
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