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CTRI Number  CTRI/2024/08/073119 [Registered on: 29/08/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To find the effect of jala nasya in the management of cervical spondylosis 
Scientific Title of Study   To Evaluate the Efficacy of Sheeta jala Nasya in the management of Manyasthambha (Cervical Spondylosis) - RCT 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sreerekha Chandran 
Designation  Post Graduate scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Thiruvallur, TAMIL NADU, India.

Thiruvallur
TAMIL NADU
600123
India 
Phone  9946622500  
Fax    
Email  sreerekhachandran@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chitta Ranjan Das 
Designation  Principal, Professor and Head of the Department. 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Room no 20, Second floor, Department of Panchakarma, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Thiruvallur, TAMIL NADU, India.

Thiruvallur
TAMIL NADU
600123
India 
Phone  9444123506  
Fax    
Email  drcrdayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chitta Ranjan Das 
Designation  Principal, Professor and Head of the Department. 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Room no 20, Second floor, Department of Panchakarma, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Thiruvallur, TAMIL NADU, India.


TAMIL NADU
600123
India 
Phone  9444123506  
Fax    
Email  drcrdayu@gmail.com  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai. 600123. 
 
Primary Sponsor  
Name  Dr Sreerekha Chandran 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Thiruvallur, TAMIL NADU, India. 
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 Sreerekha Chandran  Sri Jayendra Saraswathi Ayurveda College and Hospital  Room no 20, Second floor, Department of Panchakarma, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Thiruvallur, TAMIL NADU, India.
Thiruvallur
TAMIL NADU 		 9946622500

sreerekhachandran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee of SCSVMV, Sri Jayendra Saraswathi Ayurveda College and Hospital.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: MANYASTAMBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Rasnadi Guggulu, Reference: Yogaratnakara, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: -
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Bhava Prakasha, Procedure details: Pouring of medicated liquids in patient each nostrils.)
(1) Medicine Name: Sheeta Jala, Reference: Bhava Prakasha, Route: Nasal, Dosage Form: Sheeta/Hima, Dose: 1(ml), Frequency: od, Duration: 7 Days
3Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Bhava Prakasha, Procedure details: Pouring of medicated liquids in patient each nostrils.)
(1) Medicine Name: Jinginiyadi swarasa, Reference: Bhava Prakasha, Route: Nasal, Dosage Form: Swaras/ Juice, Dose: 1(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  74.00 Year(s)
Gender  Both 
Details  patients having signs and symptoms of cervical spondylosis (Manyasthambha) 
 
ExclusionCriteria 
Details  Patient with injury to cervical spine and spinal surgery 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
to reduce the signs and symptoms of manyasthambha (cervical spondylosis) by using Neck disability index scale and improve range of movements of cervical spine using a goniometer.  Patients will be assessed every 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 3 
Date of First Enrollment (India)   20/01/2025 
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="1"
Months="6"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 (Others) -  Google scholar

  6. For how long will this data be available start date provided 26-08-2024 and end date provided 26-02-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Nasya karma is a therapeutic procedure in which drug is administered through nose, eliminates or pacifies the vitiated doshas that are accumulated in the head and is beneficial in diseases of urdhwajatrugata. Manyasthambha is mentioned among 80 nanatmaja vikara. the lakshanas of manyasthambha include sthambha with shula at manya pradesha. Cervical spondylosis is a result of osteoarthritis in the cervical spine. it is characterized by degeneration of the intervertebral disc and osteophyte formation with clinical manifestation like restricted movements of neck along with pain and stiffness. based on this characteristic feature, manyasthambha can be best correlated to cervical spondylosis. nasya karma is the prime modality of treatment for manyasthambha, mentioned in classics. henca an attempt is made to evaluate the efficacy of seethajala nasya in the management of manyasthambha (cervical spondylosis). 
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