FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096462 [Registered on: 24/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurveda treatment for management of Gouty Arthritis 
Scientific Title of Study   A Conceptual study on Trisutra Ayurveda with special reference to Vatarakta and Its Management through Vatsadani Kwatha 
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 Anita 
Designation  PG Scholar Samhita Siddhanta 
Affiliation  Rajarajeswari Ayurvedic Medical College 
Address  Room No.03, Department of Samhita Siddhanta, Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330.
Room No.03, Department of Samhita SiddhantaRajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330.
Bidar
KARNATAKA
585330
India 
Phone  8105188789  
Fax    
Email  anitakoutge@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ravindar Korede 
Designation  Professor 
Affiliation  Rajarajeswari Ayurvedic Medical College  
Address  Dept of PG Studies in Ayurveda Samhita Siddhanta.Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330.
Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330.
Bidar
KARNATAKA
585330
India 
Phone  9440316788  
Fax    
Email  ravindarkorede@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ravindar Korede 
Designation  Professor 
Affiliation  Rajarajeswari Ayurvedic Medical College 
Address  Dept of PG Studies in Ayurveda Samhita Siddhanta.Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330.
Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330.
Bidar
KARNATAKA
585330
India 
Phone  09440316788  
Fax    
Email  ravindarkorede@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330. 
 
Primary Sponsor  
Name  Dr Anita 
Address  Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330. 
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 Anita  Rajarajeswari Ayurvedic Medical College and Hospital  Room No.03, Department of Samhita Siddhanta, Rajarajeswari Ayurvedic Medical College Hospital and PG Centre Humnabad,585330.
Bidar
KARNATAKA 
08105188789

anitakoutge@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Rajrajeswari Ayurvedic medical college,Hospital and PG Centre Humnabad.Karnataka  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vatsadani Kwatha, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Sukoshna Jala), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects having classical signs and symptoms of Vatarakta. Like Sandhi shula, Vidaha, Sandhi shooth, Sparsha asahatva, Twak vaivarnata
2. Subjects in the age group between 20-60years of either gender.
3. Subjects having serum uric acid level more than 6mg/dl to 8mg/dl.
 
 
ExclusionCriteria 
Details  1. Subjects not having classical sign and symptoms of Vatarakta.
2. Subjects below age of 20years and above 60years of either gender.
3. Pregnant and Lactating mother
4. Subjects having Serum uric acid level less than 6mg/dl and above 8mg/dl
5. Subjects having malignant disorders/any systemic disorder like DM, HTN etc
6. Any other inflammatory joint disorders like tubercular arthritis and joint injuries etc.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
relief of symptoms of Vatarakta  7th day,14th day,21th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Non recurrence of symptoms of Vatarakta.  21st Day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   04/11/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  


Ayurveda the age-old science of life is suitably explained through the enriched concept of Trisutra1 Ayurveda in a nut shell. i.e. Hetu, Linga, Aushada respectively. Hétu comprises of current and distant causative factors, Linga indicates clinical features of both healthy and diseased individuals, and Aushada consists of wholesome diet and mode of life too. Proper, systemic understanding of this concept enables an individual to reveal, explore and evaluate the findings in a scientific way to the fraternity of Ayurveda.

Vatarakta is a disease produced with ‘Khavaigunya’ of raktavahasrotas2 which includes vitiated Vata and Rakta, caused by Sanatarpana janya nidanas3. It usually starts from small joint and associated with sandhi shoola, sandhi shootha, vidaha, sparsha asahatva, twak vivarnata4 etc. It is usually compared with Gouty Arthritis mainly due to incomplete protein metabolism and excess production of uric acid and reduced renal clearance of uric acid increases these levels in blood will be deposited in the small joints of feet and hands causes Gouty arthritis5. Recent reports of the prevalence and incidence of gout vary widely and its between prevalence of <1% to 6.8% and an incidence of 0.58-2.89 per 1000 person-years6.

There are different treatment modalities are explained for vatarakta such as shodhana and shamana. Vatsadani kwatha7 is one among the drugs used in vatarakta, which consists of Guduchi and Guggulu, Guduchi having Tikta and Kashaya rasa, laghu guna, ushna virya, Madhura vipaka, and acts as tridoshashamaka, balya, dipana, rasayana, and jwaraghna8. Guggulu having Katu Tikta and Kashaya rasa, Katu vipaka, ushna virya, and tridoshahara properties9. They are non-controversial, easily available and cost effective. Here an attempt is being made to understand the literary aspect of disease thoroughly both Ayurveda and modern lines though the application of Trisutra Ayurveda to afford a proper treatment modality to the ailing society is the real need of the hour.

 
Close