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CTRI Number  CTRI/2021/08/035850 [Registered on: 23/08/2021] Trial Registered Prospectively
Last Modified On: 02/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Nasya and Patra Pinda Swedana in Vishvachi (cervical radiculopathy) 
Scientific Title of Study   Evaluation of Dashmooladi Tail Nasya and Shigru Chinchadi Patra Pinda Swedana in Vishvachi(cervical radiculopathy)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pravesh kumar  
Designation  Associate Professor 
Affiliation  Rishikul campus  
Address  Department of Panchkarma, Rishikul Campus Haridwar, Uttarakhand Ayurved University

Hardwar
UTTARANCHAL
249401
India 
Phone  7417935835  
Fax    
Email  praveshk312@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pravesh kumar  
Designation  Associate Professor 
Affiliation  Rishikul campus  
Address  Department of Panchkarma, Rishikul Campus Haridwar, Uttarakhand Ayurved University


UTTARANCHAL
249401
India 
Phone  7417935835  
Fax    
Email  praveshk312@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kalpana taledi  
Designation  PG scholar  
Affiliation  Rishikul Campus 
Address  Department of Panchkarma, Rishikul Campus Haridwar, Uttarakhand Ayurved University

Hardwar
UTTARANCHAL
249401
India 
Phone  9870817446  
Fax    
Email  kalpanataleditaledi@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus,Haridwar, Uttarakhand Ayurveda University, Dehradun 
 
Primary Sponsor  
Name  Rishikul Campus Haridwar 
Address  Department of Panchkarma,Rishikul Campus Haridwar 
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 
Kalpana Taledi  RISHIKUL CAMPUS, UTTARAKHAND AYURVEDA UNIVERSITY  OPD No. 20, Department of panchkarma, Rishikul Campus Haridwar 249401
Hardwar
UTTARANCHAL 		 9870817446

kalpanataleditaledi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics commitee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M472||Other spondylosis with radiculopathy. Ayurveda Condition: VISHVACHI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: योगरत्नाकर, Procedure details: 1 Deepana- Pachan 2 Abhyanga 3 swedana 4 nasya 8 dops /day each nostrils for 7 days with 7 days interval. total duration of therapy is 42 days )
(1) Medicine Name: dashmool tail , Reference: योगरत्नाकर, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-patrapinda swedana (Procedure Reference: आरोग्याकल्पद्रुम , Procedure details: (Procedure Reference: आरोग्याकल्पद्रुम, Procedure details: 1.abhyang on the affected part 2.bolus is prepared of medicated leaves and other ingredients 3.prepration of patra pinda 4.patra pinda swedana over the affected part ) procedure will be done in 3 sittings each sitting of 7days with 7days interval in between each sitting )
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1 Patient of both genders between the age group of 25-55 yrs of age.
2 Radiological evidence of cervical radiculopathy essentially having lesion in vertebrae C5, C6, C7.
3 Patients having signs and symptoms of vishwachi.
4 Patients indicted for nasya and patra pinda swedana.

 
 
ExclusionCriteria 
Details  1 Acute or chronic infection of spine.
2 Cancer of cervical spine.
3 Any other form of arthritis like rheumatoid arthritis,ankylosing spondylitis.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
complete remission
marked improvement
moderate improvement
mild improvement
no improvement  		 42 days 
 
Secondary Outcome  
Outcome  TimePoints 
Exacerbations in sign and symptoms   42 days  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   30/08/2021 
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="12" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Cervical radiculopathy is the clinical description of when a nerve root in the cervical spine become inflamed or damaged, resulting in a change in neurological functions. Neurological deficits, such as numbness altered reflexes, or weakness, may radiate anywhere from the neck in to the shoulder, arm, hand, or fingers. Pins and needles tingling and pain which can range from achy to shock like or burning, may also radiate down into the arm and hand.
Being an Urdhwajatrugatavikara, Nasya karma has been mentioned as the prime line of treatment[8]. Dhatukshaya can be considered as main factor leading to a condition like Vishwachi. Hence in order to find an effective solution in this condition, Snehana Nasya with dashmooladhya Taila   and shigru chinchadi patra pinda swedana has been taken for the study. 
 
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