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CTRI Number  CTRI/2025/06/089594 [Registered on: 26/06/2025] Trial Registered Prospectively
Last Modified On: 25/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two ayurvedic treatments for gout with herbal purgation and medicated enema therapy 
Scientific Title of Study   Randomized comparative clinical study to evaluate efficacy of virechan karma using Kashmaryadi kashay and Ardhamatrik niruh basti in vaatrakta with special reference 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  Shubhada Santosh Kulkarni  
Designation  PG scholar  
Affiliation  Arogyashala Rugnalaya Ganeshwadi Nashik 
Address  OPD NO 20 Arogyashala Rugnalaya Ganeshwadi Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  7410139493  
Fax    
Email  kulkarnishubhada123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Savita Kulkarni  
Designation  Guide and HOD 
Affiliation  Arogyashala Rugnalaya Ganeshwadi Nashik 
Address  OPD NO 20 Arogyashala Rugnalaya Ganeshwadi Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  9423081487  
Fax    
Email  drsavita.k07@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shubhada Santosh Kulkarni  
Designation  PG scholar  
Affiliation  Arogyashala Rugnalaya Ganeshwadi Nashik 
Address  OPD NO 20 Arogyashala Rugnalaya Ganeshwadi Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  7410139493  
Fax    
Email  kulkarnishubhada123@gmail.com  
 
Source of Monetary or Material Support  
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 422003 
 
Primary Sponsor  
Name  Dr Shubhada Santosh Kulkarni  
Address  OPD NO 20 Arogyashala Rugnalaya Ganeshwadi Nashik 422003 Maharashtra 
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 Shubhada Santosh Kulkarni   Arogyashala Rugnalaya  OPD NO 20 Panchakarma OPD
Nashik
MAHARASHTRA 
7410139493

kulkarnishubhada123@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:M258||Other specified joint disorders. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma (Procedure Reference: chakradatta, Procedure details: basti once a day)
(1) Medicine Name: dashamula kwath, Reference: chakradatta, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: charak chikitsasthan 29, Procedure details: After snehapana & samyak snugdh lakshan kashmaryadi kashay will be given to the patient and kept under supervision for 24 hours)
(1) Medicine Name: kashmaryadi kashay, Reference: charak chikitsasthan 29, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Diagnosed patients of Vataraktawith symptom such asSandhishula,Sandhidaha, Sparshasahatva,Sandhishoth, Sandhivaivarnya.
Patient with raised Serum Uric Acid Level (more than 7.0 in Male and more than 6.0 in Female)
Patients between age group 20 -70 years of either sex.
Patient willing for trial and giving written cosent.
Patient with all socio-economic status.
virechan arha and basti arha 
 
ExclusionCriteria 
Details  Below 20yrs. and above 70 years old patients With Known case of major systemic disorder such as IHD, MI, Uncontrolled DM, Uncontrolled Hypertension, CKD
Patients other than Gouty Arthritis
Virechan anarha and basti anarha
Patient not willing for trial.
Pregnant and lactating mother
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
decrease in serum uric acid level  7 days
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of Kashmaryadi kashay as virechan kalpa & ardhamatrik niruh basti as pain reliever in Vatarakta using VAS Scale.
To study the effect of Kashmaryadi kashay as virechan kalpa in decreasing Serum Uric Acid Level in Vatarakta using Serum Uric Acid test. 
7 days 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   09/07/2025 
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="0"
Months="3"
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 - NO
Brief Summary   Vatarakta is a great medical problem throughout the world. It is a great enemy in the society, because it distresses the human life. In Ayurvedic context, various treatment modalities have been suggested to get rid of this disease. In Vatarakta, both Vata and Rakta get aggravated and vitiated by their hetus and ultimately vayu gets obstructed by vitiated Rakta.
The classical texts lay down ample importance to the functions and characteristics of vata. At the same time, rakta being the foremost body tissue also plays an important role in sustaining the healthy life style of a person. Vatarakta is a disease where both VataandRakta are afflicted by distinct etiological factors. The disease characterized by the abnormality of raktadhatu due to morbidity of vatadosha is called as Vatarakta. “Vatadushitamraktam yatra rogavisheshah”
Vata dosha becomes enraged by frequent use of Kashaya(astringent), katu (pungent), Tikta (bitter), Alpahara(scanty diet), RukshaAhara(dry food articles), Abhojana(abstinence of food) or by regular riding on Ashva(horse), Ushtra(camel) or Yana(vehicle) etc;this agitated Vataenters into blood through carrying channels of the body and gets obstructed in its passage by vitiated Rakta Dhatu, thus affecting the entire blood and leading to Vatarakta.
Once again Acharya Charaka described that Vata due to its Sukshmatva (subtleness), Sarvasaratva (pervasiveness) properties and Rakta due to its Dravatva(liquidity), Saratva (flowing nature) properties; circulate through the body and blood vessels (RaktavahaSrotasa) and get obstructed in Sandhi(joints). Due to torsion nature of its course in joints;Rakta and Vata again get agitated. After localization and in combination with Pitta Dosha they cause different types of Shula (pain) according to predominance of Doshas. Vatarakta is an age old common condition prevalent all over the world.
On the basis of symptomatology and chronicity of disease, this can be correlated with a similar condition of modern medicine named as Gout.Gout is a clinical syndrome and is a group of metabolic diseases in which clinical manifestation is associated with tissue deposition of crystals of monosodium urate monohydrate from Hyperuricemia body fluids.
Incidence of Gout appears to have increased over in a few decades due to increasing industrialization,urbanization,faultydietary habits,radiation, drug toxicity and other factors responsible directly or indirectly for the disease Gout. Hyperuricemia and Gout may result from increased urate production or decreased uric acid excretion or both.
Reported prevalence of Gouty Arthritis is 2.0 to 2.6 per 1000 patients, usually between the age group of 25-50 years.
Sushruta explained Vatarakta entity in ‘Mahavatavyadhichikitsa’. Hence it is an identical one among all other vatavyadhyi. It is also known as vatashonita, khhuddavata, vatabalas, and aadhyavata.
Panchakarma is treatment modality used very extensively and effectively in Ayurveda. It plays an important role in Vatarakta. Acharya Charaka elaborate virechan as Shodhan karma in vaatrakta specifically in pittaj and raktaj type. 
A medicine which is clinically viable, cost effective, easy to administer, gives early recovery and minimize the discomfort to the patient is in high demand. Kashmaryadi kashayas virechan kalpa is one of the preparations especially mentioned by charak. Acharya Charak has clearly mentioned the relevance of Kashmaryadi kashay as virechan kalpa in VataraktaChikitsa. So in the present study Kashmaryadi kashay as virechan has been selected.With this, NidanaParivarajana and PathyaApathya will be advised to the patients.Out of which I have selected Kashmaryadi kashay as virechan in one group and Ardhamatrik niruh basti in another group for given duration in Vataraktavya.
 
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