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CTRI Number  CTRI/2024/01/062060 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On: 30/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Siravyadha(blood letting)in vata raktha (gout) 
Scientific Title of Study   A Randomized clinical study to evaluate the efficacy of sirvyadha with or without jatamayadi lepa in vata - rakta w.s.r to gout 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sambu Surendran 
Designation  PG scholar MS (AYU) 
Affiliation  HASS Ayurveda Mahavidhyalaya Hubballi. 
Address  ROOM NO. 17 Department of PG and PhD studies in Shalya tantra Ayurveda Mahavidyalaya and Hospital HeggeriExtension Old Hubballi

Dharwad
KARNATAKA
580024
India 
Phone  08086926586  
Fax  122  
Email  drsambusurendran@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SIDDANAGOUDA A PATIL  
Designation  Professor Department of PG and PhD studies in Shalya tantra 
Affiliation  DepartmHASS Ayurveda Mahavidyalaya and Hospital, HeggeriExtension, Old Hubballi 
Address  Department of PG and PhD studies in Shalya tantra Ayurveda Mahavidyalaya and Hospital HeggeriExtension Old Hubballi

Dharwad
KARNATAKA
580024
India 
Phone  9448565198  
Fax    
Email  drsapatilms@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SIDDANAGOUDA A PATIL  
Designation  Professor Department of PG and PhD studies in Shalya tantra 
Affiliation  DepartmHASS Ayurveda Mahavidyalaya and Hospital, HeggeriExtension, Old Hubballi 
Address  Department of PG and PhD studies in Shalya tantra Ayurveda Mahavidyalaya and Hospital HeggeriExtension Old Hubballi

Dharwad
KARNATAKA
580024
India 
Phone  9448565198  
Fax    
Email  drsapatilms@gmail.com  
 
Source of Monetary or Material Support  
HASS AYURVEDA MAHAVIDHYALAYA AND HOSPITAL HUBBALLI 
 
Primary Sponsor  
Name  Dr Sambu Surendran 
Address  HASS Ayurveda Mahavidhyalaya,Heggeri colony,Old Hubballi,Hubballi,Karnadaka,580030 
Type of Sponsor  Private medical college 
 
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 Sambu Surendran  HASS Ayurveda Mahavidhyalaya Hubballi  Room number 16 , Department of Shalya Thantra, HASS Ayurveda Mahavidhyala , Heggeri colony,Old, Hubballi,Hubballi
Dharwad
KARNATAKA 
08086926586

drsambusurendran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurveda Mahavidhyalaya Hubli  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M100||Idiopathic gout. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  a.Subject with hyperuricemia and presenting with lakshanas of Vatarakta.
b.Chronicity less than 5 years,
c.Not associated with complete joint destruction.
d.Uric acid above 7 mg/dl
 
 
ExclusionCriteria 
Details  a. Subject with major illness like hepatitis, AIDS, malignancy and RA factor positive.
b. Subject with uncontrolled diabetes mellitus and hypertension, Koch’s arthritis, Septic arthritis, Chronic renal failure, Severe Systemic multi organ syndromes and uric acid cristal stones.
c. Subjects on opioids, anticoagulant drugs.
d. Classical contraindications for siravyadha procedure.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)reduction in the range of serum uric acid will be assessed.  Base line - serum uric acid will be assessed and 1 st sitting of Siravyadha
1 st follow up after 7days and second sitting of siravyadha serum uric acid will be assessed
2 nd follow up 21 days after baseline and 3 rd sitting of siravyadha , serum uric acid will be assessed
3rd followup after 28 days of baseline and 4th sitting of siravyadha , serum uric acid will be assessed


 
 
Secondary Outcome  
Outcome  TimePoints 
1)reduction in the range of serum uric acid
2) symptomatic changes like pain , burining sensation , swelling & discoloration after inntervention
 
1) monitoring the value of serum uric acid after every sitting of siravyadha that is baseline , after 7days ,14 days , 21 days & 28 days .
2)assessing the grade of symptomatic changes after every sitting of siravyadha that is baseline , after 7days ,14 days , 21 days & 28 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 4 
Date of First Enrollment (India)   10/02/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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

  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 [drsambusurendran@gmail.com].

  6. For how long will this data be available start date provided 01-12-2023 and end date provided 25-12-2050?
    Response - Immediately following publication. No end date.

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

Vatarakta is a metabolic disorder and a grievous medical condition. It is one among Vatavyadi caused due to avarana (occlusion). As the name suggest it is due to the vitiation of Vata Dosha and Rakta Dhatu (blood). 

Vatarakta is classified in to - Uttana Vatarakta and Gambhira Vatarakta on the basis of dhatu involvement, symptoms of uthana vatarakta are Kandu, Daha, Ruja, Ayama, Toda, Spurana, Kunchana, Raga, Bheda, Gourava and Suptata.

 Gout is a common type of arthritis; the symptomatology of this has striking similarities with those explained in Vatarakta

This is due to excess accumulation of uric acid  in the blood stream which  forms crystals in the joint that causes intense pain,  swelling  and  stiffness in phalanges,  it  usually  affects  the  joint  of  the  big  toe and is marked  by  transient painful attacks of acute arthritis initiated by crystallization of urates,eventually it leads to chronic gouty arthritis and the deposition of masses of Monosodium  Urate  (MSU)  crystals    in  joints  and  other sites,  creating  tophi. The essential biochemical requirement for the development of clinical gout is hyperuricemia.                 The management of Vatarakta aims at Vata Hara and Rakta Prasadaka measures.  In this respect the Shodhana chikitsa like Raktamokshana (Siravyadha)  is advised as primary treatment by Acharya, Raktamokshana  (Siravyadha)  is  a  unique  subset  of accredited drugless surgical technique in Ayurveda; often ignored,  misunderstood  in  the  mainstream  practice. It is indicated primarily in generalized vitiation of blood, causing distress.  Siravyadha treatment relieves the symptoms early, modifies the underlying pathology and also reduces the duration of treatment. it can  bring  down  the  oral  medicine  burden  to  the  patient which has to be taken for years together.

In sahasrayoga, thaila prakarana, kalka dravya of balaguluchyadi taila i.e., Jadamayadhi churna which ingredients are sheeta veerya   can reduces raga, shopha, daha and shola caused due to vata rakta.


 
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