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CTRI Number  CTRI/2024/05/067546 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect of Nasya karma with Dashmool-Bala-Masha siddha taila and Shuddha bala taila in the management of Vishwachi w.s.r Cervical spondylosis. 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy on Marsha Nasya with Dashmool-Bal-Masha siddha taila and Shuddha bala taila in the management of Vishwachi w.s.r Cervical spondylosis with radiculopathy. 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shalini Jha 
Designation  MD Ayurveda scholar ((Panchkarma) 
Affiliation  GACH,Patna 
Address  Government Ayurvedic college and Hospital,Near Buddh Murti,Kadamkuan,Patna-800003

Patna
BIHAR
800003
India 
Phone  9650260847  
Fax    
Email  shalinijha1995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Akhilesh Prasad Singh 
Designation  Associate Professor 
Affiliation  GACH,Patna 
Address  Department of Panchkarma,Government Ayurvedic college and Hospital,Near Buddh Murti,Kadamkuan,Patna
Government Ayurvedic college and Hospital,Near Buddh Murti,Kadamkuan,Patna,Bihar, India,800003
Patna
BIHAR
800003
India 
Phone  8002680973  
Fax    
Email  drapsinghpatna@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Akhilesh Prasad Singh 
Designation  Associate Professor 
Affiliation  GACH,Patna 
Address  Department of Panchkarma, Government Ayurvedic college and Hospital, Near Buddh Murti, Kadamkuan, Patna
Department of Panchkarma, Government Ayurvedic college and Hospital, Near Buddh Murti, Kadamkuan, Patna-800003
Patna
BIHAR
800003
India 
Phone  8002680973  
Fax  -  
Email  drapsinghpatna@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic college and Hospital,Near Buddh Murti,Kadamkuan,Patna,Bihar-800003,India 
 
Primary Sponsor  
Name  Shalini Jha 
Address  Government Ayurvedic college and Hospital,Near Buddh Murti,Kadamkuan,Patna-800003 
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 Shalini Jha  Government Ayurvedic college and Hospital  OPD No.11,Department of Panchkarma,Government Ayurvedic college and Hospital,Near Buddh Murti,Kadamkuan,Patna
Patna
BIHAR 		 9650260847
-
shalinijha1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE(IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M501||Cervical disc disorder with radiculopathy. Ayurveda Condition: VISVACI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Sushrut samhita chikitsa sthan-40/21, Procedure details: Nasya karma to be done for a period of 15 days on every alternate day beginning from Day-1.)
(1) Medicine Name: Dashmool-Bala-Masha siddha tail, Reference: Bhaisajya Ratnawali(Vaatvyadhi prakaran), Route: Nasal, Dosage Form: Taila, Dose: 8(ml), Frequency: od, Duration: 15 Days
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Sushrut samhita chikitsa sthan-40/21, Procedure details: Nasya karma to be done for a period of 15 days on every alternate day beginning from Day-1.)
(1) Medicine Name: Shuddh Bala taila, Reference: Sahasrayogam, Route: Nasal, Dosage Form: Taila, Dose: 8(ml), Frequency: od, Duration: 15 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient showing the sign and symptoms of cervical spondylosis without any history of trauma.
Patients having signs and symptoms(pratyatma lakshan)of Vishwachi.
Patients indicated for Nasya therapy. 
 
ExclusionCriteria 
Details  Acute or chronic infection of spine.
Cancer of cervical spine.
Any other form of arthritis like Rheumatoid arthritis,SLE.Patients contraindicated for Nasya karma.
Patient with pathologies like cardiac disease,renal disease,vertebral fusion,malignancy and acute disc prolapses etc.
Pregnant and lactating mothers. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The improvement of the patients will be assessed mainly on the basis of relief in the cardinal symptoms of disease.To access the effect of therapy subjectively,all the signs and symptoms will be relieved i.e
1.pain in the neck joint
2.restricted movement of affected part
3.weakness of the arm and forearm region 		 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
The radiological analysis of X-RAY of cervical spine before and after the treatment and during the follow up to compare the condition of cervical spine.  30 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 
Date of First Enrollment (India)   25/05/2024 
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="8"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shalinijha1995@gmail.com].

  6. For how long will this data be available start date provided 25-04-2025 and end date provided 25-04-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nill
Brief Summary   The study is Randomised clinical trial to study the safety and efficacy of Nasya with Dashmool-bala-masha siddha taila and shuddha bala taila in patients of Vishwachi w.s.r to Cervical spondylosis with radiculopathy in two groups of 20 patients each for a time period of 30 days.This study will be conducted in Government Ayurvedic college and Hospital,Patna,Bihar in the department of Panchkarma.After 15 days of intervention two follow ups will be done on Day-15 and Day-30.. 
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