FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/02/023356 [Registered on: 14/02/2020] Trial Registered Prospectively
Last Modified On: 23/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Back pain management by ayurvedic procedure 
Scientific Title of Study   A Comparative Clinical study of Agnikarma with Panchdhatu shalaka and Raktamokshana with Modified Shring yantra in Management of Kati Sandhigata vata (Lumbar Spondylosis). 
Trial Acronym  LBA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Poona nath chouhan 
Designation  Research scholar 
Affiliation  IPGT and RA GAU jamnagar 
Address  OPD NO 2 Department of Shalya Tantra IPGT and RA Gujarat ayurved university Jamnagar
Opposite B Division Police station Department of Shalya Tantra IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  7742038214  
Fax    
Email  www.poonanath@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T S Dudhamal 
Designation  Associate professor 
Affiliation  IPGT and RA GAU Jamnagar 
Address  Room No 633 6th Floor Department of Shalya Tantra IPGT and RA GAU Jamnagar
Opposite B Division Police station OPD No 1 Department of Shalya Tantra IPGT and RA Gujarat ayurved university Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  drtsdudhamal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr T S Dudhamal 
Designation  Associate professor 
Affiliation  IPGT and RA GAU Jamnagar 
Address  Department of Shalya Tantra IPGT and RA GAU Jamnagar
Opposite B Division Police station Department of Shalya Tantra IPGT and RA Gujarat ayurved university Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  drtsdudhamal@gmail.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  IPGT and RA GAU Jamnagar 
Address  Opposite B Division Police station IPGT and RA 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 
Poona nath chouhan  PG Hospital IPGT AND RA JAMNAGAR  OPD no 1 Shalya Tantra department UNIVERSITY, JAMNAGAR
Jamnagar
GUJARAT 		 7742038214

www.poonanath@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: M478||Other spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A Agnikarma procedure  minimum 15 patients of clinically diagnosed Kati Sandhigata Vata (Lumbar Spondylosis) will be treated with Agnikarma procedure 
Comparator Agent  group B Modified Shringa Yantra  Minimum 15 Patients of clinically diagnosed Kati Sandhigata Vata (lumber Spondylosis) will be treated with Raktamokshan by modified shringa yantra 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient suffering from kati Sandhigata Vata (Lumber Spondylosis) irrespective to demographic data
Patients between age group 30-70 years of both sex
Yogya of Agnikarma
Twak Mansh Sira Snayu Sandhi Asthi Sthit Vayu Pidit
Vayu ucchit Kathin Suptmansh
Granthi Arbud Arsh Bhandar Apachi Shlipad Charmkeel Tilkalaka
Antravridhi
Sandhi Sira Chhedan
Nadishonit Atiprivriti
Yogya of Raktmokshan
Mukhpaka Akshiroga Pootigranaasytagandhita
Gulm Upkush Visharpa Raktpitt Pramilika
Vidhradi Raktameh Pradar Vatashonit
Vivaranya Agnisaad Pipasagurugatrta
Santap Atidorbalya Aruchi Shirsch Ruk
 
 
ExclusionCriteria 
Details  Patients of uncontrolled diabetes mellitus R.A. (Rheumatoid arthritis) positive.
Other diseases like paralysis Parkinson’s disease severe anaemia malignancy
Patients below 30 years and above 70 years
Pregnancy
Protrusion of lumbar disc & disc prolapse
Heart disease(IHD,CCF)
Ayogya for Agnikaram
Pitta dominant Prakruti patients
Antashonit (Internal Haemorrhage)
Bhinnkostha (Diarrhoea)
Anudhrit shalya (Unexpelled foreign object )
Durbal(Weak) Bala(Minors) and Vridh (old age)
Bhirum (Scared) Anek Vran Pidit(multiple wound affected)
Asvedhya(Swedan Aayogya)
Ayogya for Raktmokshna
Sarvangsoph (Ana sarca)
Kshin chha Amalbhojananimit(weak person with Sour diet intake)
Pandu rogi (anaemic)
Arsh rogi (Piles in Ano)
Udar rogi (Abdominal disease)
Shosh rogi (Koch’s disease)
Garbhini (Pregnant women)
 
 
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 kati Sandhigata Vata   one month from the day of enrollment of patient 
 
Secondary Outcome  
Outcome  TimePoints 
Improves quality of life of person  After 2 months from the day of enrollment 
 
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)   18/02/2020 
Date of Study Completion (India) 31/05/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

The trial initiated with the aim and objective to assess the clinical efficacy of Agnikarma and Raktamokshana in the management of Kati Sandhigata Vata (Lumber spondylosis). In this study total of 32 patients were enrolled which were allocated into two non-comparative clinical parallel groups. 15 patients in Group A and 15 patients in Group B completed treatment as well follow-up, 2 patients were dropped out during treatment time.

In Group A 15 patients were managed with Agnikarma by Panchdhatu Shalaka at the most tender area in the lumbar region. 4 sittings were done with an interval of 7 days for the period of one month.

In Group B 15 patients were managed with Raktamokshana by modified Shringayantra (Chinese Cups) in the most tender in the lumbar region. 2 sittings were performed with an interval of 15 days.

The assessment was done on relief in sign and symptoms of Kati Sandhigata Vata like Kati Shoola (Lumber pain), Kati Stambha (Lumber stiffness), Kati Suptata (Lumber numbness), Akunchana Prasarane Pravritti Savedana (restricted lumber joint movements) weekly for 1 month. Follow-up was done up to 1 month for the period of one month after the treatment in both groups.

The study concluded that both the para-surgical modalities are highly effective in managing chief complaints like Agnikarma is better in managing Kati Shoola (Lumber pain) and Kati Stambha (Lumber stiffness) while Raktamokshana is better in managing Kati Suptata (Lumber Numbness) and Akunchana Prasarane Pravritti Savedana (Restricted lumber joint movement) but statically there is an insignificant difference among them i.e., the null hypothesis is accepted and the alternate hypothesis is rejected for this trial.

 


 
Close