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CTRI Number  CTRI/2019/01/016958 [Registered on: 08/01/2019] Trial Registered Prospectively
Last Modified On: 30/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Aganikarma & Raktamokshana in Cervical spondylosis 
Scientific Title of Study   A comparative clinical efficacy of Agnikarma and Raktamokshana (By modified Shringa Yantra) along with Panchatikta Guggulu in the management of Grivasandhigatvata (Cervical spondylosis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ekta D Patel 
Designation  MS 2nd Year 
Affiliation  IPGT and RA Jamnagar 
Address  6th floor Shalya tantra Department IPGT and RA Jamnagar
Opd no 1 Sushrut bhavan IPGT RA Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  8141291727  
Fax    
Email  ekta2810patel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T S Dudhamal 
Designation  Associate Professor 
Affiliation  IPGT and RA Jamnagar 
Address  6th floor Shalya tantra Department IPGT and RA Jamnagar
Opd no 1 Sushrut bhavan IPGT RA Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  dudhamal@ayurveduniversity.com  
 
Details of Contact Person
Public Query  
Name  Dr T S Dudhamal 
Designation  Associate professor 
Affiliation  IPGT and RA Jamnagar 
Address  6th floor Shalya tantra Department IPGT and RA Jamnagar
Opd no 1 Sushrut bhavan IPGT RA Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  dudhamal@ayurveduniversity.com  
 
Source of Monetary or Material Support  
Institute for post graduate teaching and research in Ayurveda Gujarat ayurved university Jamnagar Gujarat 361008 
 
Primary Sponsor  
Name  institute for post graduate and research center 
Address  Gujarat ayurved university Jamnagar 
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 
Ekta D Patel  PG hospital IPGT and RA   Opd no 1 shalya department PG hospital IPGT and RA Jamnagar
Jamnagar
GUJARAT 		 8141291727

ekta2810patel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Agnikarma with Panchatikta Guggulu  group A patient was treated with Agnikarma by Panchdhatu shalaka four times at 7 days interval as well as Panchtikta guggulu given 2 vati orally three times in a day with Luke warm water Total duration of therapy 30 days 
Intervention  Raktamokshana with Panchatikta Guggulu  group B patient was treated with Raktamokshana by modified Shringa yantra two times at 15 days interval as well as Panchtikta guggulu given 2 vati orally three times in a day with Luke warm water Total duration of therapy 30 days  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Agnikarma and Raktamoksana yogya patients as per classic  
 
ExclusionCriteria 
Details  1 Age below 30 and above 70 years.
2 Uncontrolled Diabetes Mellitus & Hypertension
3 T.B. of cervical spine & Malignancy
4 Fracture related to cervical spine.
5 Heart diseases (IHD, CCF)
6 Anemia (Hb< 7%)
7 Pregnancy
8 Agnikarma and Raktamokshana ayogya patients as per classic
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief in sign and symptoms of Grivasandhigatvata  Relief in sign and symptoms of Grivasandhigatvata 
 
Secondary Outcome  
Outcome  TimePoints 
Improves quality of life of Person  Improves quality of life of Person 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   18/01/2019 
Date of Study Completion (India) 16/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="2" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
This study comprise a clinical study to evaluate the effect of agnikarma and raktmokshana along with Panchtikta guggulu in the management of Grivasandhigatvata (cervical spondylosis) . Procedure in group A Agnikarma by Panchdhatu shalaka (n=15) and in group B Rakmokshana (n-15) by modified shring yantra was done.And Panchtikta guggulu is given in both group two vati(500mg) three times in a day. Statestically insignificant diffrance found between the grops. But clinically and percentage wise better relief was found in patients of group B than patients of group A in Grivasandhishula, Grivasandhistambh, Akunjana Prasarana Vedna, forward flexion, right lateral flexion and left lateral flexion. And in patients of group A better relief was found in NDI score, backward extension, rotation towards right & rotation towards left than patients of group B.After 4 weeks of treatment it was observed that in group A complete remission in signs and symptoms were observed in 20% (03) patients, marked improvement was noticed in 60% (09) patients; moderate improvement in 20% (03) patients; and mild improvement and no improvement was not found in any patients.   After 4 weeks of treatment it was observed that in group B complete remission in signs and symptoms were observed in 20% (03) patients, marked improvement was noticed in 66.66% (10) patients; moderate improvement in 02% (13.33) patients; and mild improvement and no improvement was not found in any patients.Thus, null hypothesis is accepted and alternative hypothesis is rejected.   Agnikarma with Panchatikta Guggulu & Raktamokshana with Panchatikta Guggulu are equally effective in the management of Grivasandhigatvata (cervical spondylosis).  
 
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