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CTRI Number  CTRI/2022/05/042679 [Registered on: 19/05/2022] Trial Registered Prospectively
Last Modified On: 04/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic Management of Manyagraha (cervical spondylosis) 
Scientific Title of Study   “Randomized Controlled Trial of Vatanashak Ghanavati with Anu Tail Nasya in Manyagraha with special reference to Cervical Spondylosis, specifically on Oswestry Neck Disability Index” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pranali Ashok Waykar 
Designation  PG Kayachikitsa Scholar 
Affiliation  Goverment Ayurved College, Nagpur 
Address  Kayachikitsa Department,2nd floor,Sakkardara Square,Raje Raghuji Nagar,Nagpur 440024

Nagpur
MAHARASHTRA
440024
India 
Phone  7057359491  
Fax    
Email  pranali22waykar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sushil Chawre 
Designation  Assistant Professor Kayachikitsa Department 
Affiliation  Goverment Ayurved College, Nagpur 
Address  Kayachikitsa Department,2nd floor,Sakkardara Square,Raje Raghuji Nagar,Nagpur 440024
Kayachikitsa Department,2nd floor,Sakkardara Square,Raje Raghuji Nagar,Nagpur 440024
Nagpur
MAHARASHTRA
440024
India 
Phone  9923755771  
Fax    
Email  sushilvilaschawre@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sushil Chawre 
Designation  Assistant Professor Kayachikitsa Department 
Affiliation  Goverment Ayurved College, Nagpur 
Address  Kayachikitsa Department,2nd floor,Sakkardara Square,Raje Raghuji Nagar,Nagpur 440024
Kayachikitsa Department,2nd floor,Sakkardara Square,Raje Raghuji Nagar,Nagpur 440024
Nagpur
MAHARASHTRA
440024
India 
Phone  9923755771  
Fax    
Email  sushilvilaschawre@gmail.com  
 
Source of Monetary or Material Support  
OPD, IPD and casualty of Kayachikitsa Department of GAC Nagpur 
 
Primary Sponsor  
Name  Self Pranali Ashok Waykar 
Address  Kayachikitsa Department,2nd floor,Sakkardara Square,Raje Raughji Nagar,Nagpur 440024 
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 
Pranali Ashok Waykar  Government Ayurveda College And Hospital, Nagpur  Kayachikitsa Department,2nd floor,Sakkardara Square,Raje Raughji Nagar,Nagpur 440024
Nagpur
MAHARASHTRA 		 7057359491

pranali22waykar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee Government Ayurved College and Hospital Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: Manyagraha,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Vatanashak Ghanavati, Reference: Chakkradatta , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients having signs and symptoms of Manyagraha according to classics.
2. Radiological changes i.e., degenerative changes in cervical vertebrae.
3. The Oswestry neck disability questionnaire, which has been described in criteria of assessment will be taken into account where score ≥ 10 will be included.
4. Patient with age group 30-70 yrs irrespective of sex, occupation, socio-economic status.
5. Patient willing and able to participate in the study and agrees to fill the consent form.
6. Patients not willing for trial.
 
 
ExclusionCriteria 
Details  History of any fracture of vertebral joint/ surgical/ diagnostic intervention with reference to affected joints will be excluded.
1. The patient who had fix joint or having developed contracture not be included in study.
2. Patient who are not fit for Nasya.
3. Patient with uncontrolled hypertension and uncontrolled diabetes will be ruled out.
4. Patient who have serious and complicated systemic disorders will be excluded.
5. Patient with evidence of malignancy.
6. Patient on prolonged (≥6weeks) medication with corticosteroids, non steroidal anti- inflammatory drug, antidepressants, anti cholinergic etc. or any drugs that may influence on the outcome of the study.
7. Pregnant / lactating women.
8. Patients who had participated in any other clinical trial since last six months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Oral administration of Vatanashak Ghanavati with Anu Tail Nasya is more effective as Erandamula Ghanavati with Anu Tail Nasya in patients of Manyagraha with reference to cervical spondylosis specifically on Oswestry Neck Disability Index.  3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Oral administration of Vatanashak Ghanavati with Anu Tail Nasya is more effective than Erandamula Ghanavati with Anu Tail Nasya in patients of Manyagraha with reference to cervical spondylosis specifically on Oswestry Neck Disability Index.  21 days 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   01/06/2022 
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)   Completed 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 NIL 
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
    Response - Informed Consent Form

  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 - Proposals should be directed to [pranaliawaykar@gmail.com].

  6. For how long will this data be available start date provided 15-02-2021 and end date provided 05-02-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Plan of Work: 

After  Institutional Ethics Clearance of Government Ayurved College, Nagpur screening of population will be done from patients in OPD, IPD and casualty of our institute. In the clinical study 76 patients of Manyagraha will be included. If patient fulfill the criteria of inclusion, subject would also be given freedom to ask the questionsand all questions will be answered. If he/she agrees for participation in the study and found fit to include, the patient will be included in the study.

The treatment will be given to patient as follows:

1. Nasya with Anu Tail (21 days)

2. Vatanashak Ghanavati (21 days) 

      In study assessment on Oswestry Neck Disability Score and symptoms of Manyagraha will be taken on zero day (B.T. Assessment) and on 22nd day after completion of 21 days of course of treatment. (A.T Assessment).  

Medium of Dissertation: The study will be written in English and Sanskrit words will be used where ever necessary.


Type of study : Open Label Parallel Superiority Randomized Controlled Trial

 

Duration of Treatment: 21 days.

Ethical Clearance: Clearance from Institutional Ethics Committee.

Study  setting:  OPD, IPD and casualty of our institute.

Duration of

study: Study will be carried out for 18 months after approval of synopsis.

 Study Population :

1.       All the patients attending OPD, IPD and casualty of our institute will be considered in this study.

2.      Patient will be diagnosed on the basis of Oswestry Neck Disability Questionnaire, Radiological changes, i.e, degenerative changes in cervical vertebrae will also be considered.

3.      Patient with signs and symptoms of Manyagraha will also be the criteria for selection of patient.

Sample size:



   

Sample size was calculated with the help of Data     published by Solanke S. et all (2021) entitled as “Randomized Control Trial On Erandmula Ghanavati With Nasya In Manyagraha With Special Reference To Cervical Spondylosis.” In his Data The Main Criteria of assessment of Oswestry Neck Disability Questionnaire was considered. He had treated the patients of Manyagraha w.s.r  to Cervical Spondylosis by Erandmula Ghanavati along with Nasya.
The mean of Oswestry Neck Disability Score before starting treatment was 20.32 + 2.70 (considering 10% of the difference from Mean of Oswestry Neck Disability Index i.e. 2.032 of treated Group which is 18.29). The sample data was placed in Open epi sample size calculator software and the sample size was calculated. It was 29.

1.   Further making it a round figure sample size is taken as 30.   By considering the 10% dropout and 10% unresponsive. Therefore sample size is 38. Thus patients in Group A are 38, patients in Group B are 38. Total Sample=76

2.   Considering the incidence in OPD data of Kayachikitsa department and present situation, patients randomly suffering from Manyagraha, fulfilling criteria of diagnosis will be registered, among these 76 will be studied in this series from the population.

3.           Out of 76 patients 38 patients in each of Trial and Control Groups will be included.

4.           Therefore 76 patients will be selected  to be studied in this series by Random Generator Software.

 
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