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CTRI Number  CTRI/2025/07/091435 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Single Arm Clinical Study To Assess The Efficacy Of Vatari Guggul In Amavata (Rheumatoid Arthritis) With Special Reference To C-Reactive Protein 
Scientific Title of Study   Single Arm Clinical Study To Assess The Efficacy of Vatari Guggul in Amavata(Rheumatoid Arthritis) With Special Reference To C-rective Protien  
Trial Acronym  Vatari Guggul 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaibhav Shyam Athawale 
Designation  PG scholar 
Affiliation  LRP Ayurvedic medical college and hospital 
Address  LRP Ayurvedic Medical College,Hospital, PG Institute and Research Centre Islampur, Department of Rognidan , Division No 1 , Room no 1 tq. Walwa Dist. Sangli Sangli MAHARASHTRA 415409 India
LRP Ayurvedic Medical College, Hospital, PG Institute and Research Centre Islampur, Department of Rognidan, Division No 1, Room no 1, tq. Walwa, Dist. Sangli, Sangli, MAHARASHTRA, 415409 India
Sangli
MAHARASHTRA
415409
India 
Phone  9588428904  
Fax    
Email  dr.vaibhav.aayu7181@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhimanyu Patil 
Designation  Professor  
Affiliation  LRP Ayurvedic medical college and hospital 
Address  LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Islampur, Department of Rognidan , Division No 1 , Room no 1 tq. Walwa Dist. Sangli Sangli MAHARASHTRA 415409 India
LRP Ayurvedic Medical College, Hospital, PG Institute and Research Centre Islampur, Department of Rognidan, Division No 1, Room no 1, tq. Walwa, Dist. Sangli, Sangli, MAHARASHTRA, 415409 India
Sangli
MAHARASHTRA
415409
India 
Phone  9960538603  
Fax    
Email  manyupatil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhimanyu Patil 
Designation  Professor  
Affiliation  LRP Ayurvedic medical college and hospital 
Address  LRP Ayurvedic Medical College, Hospital, PG Institute and Research Centre Islampur, Department of Rognidan , Division No 1 , Room no 1 tq. Walwa Dist. Sangli Sangli MAHARASHTRA 415409 India
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Islampur, Department of Rognidan, Division No 1, Room no 1, tq. Walwa, Dist. Sangli, Sangli, MAHARASHTRA, 415409 India
Sangli
MAHARASHTRA
415409
India 
Phone  9960538603  
Fax    
Email  manyupatil@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Vaibhav Shyam Athawale 
Address  LRP ayurvedic medical college, hospital PG institute, Islampur 
Type of Sponsor  Other [Other(self)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaibhav Shyam Athawale  LRP Ayurvedic Medical College and Hospital  LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Islampur, Department of Rognidan , Division No 1 , Room no 1 tq. Walwa Dist. Sangli Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA 		 9588428904

dr.vaibhav.aayu7181@gmail.com 
Dr Vaibhav Shyam Athawale  LRP Ayurvedic Medical College and Hospital  LRP Ayurvedic Medical College, Hospital Post Graduation Institute and Research Centre Islampur, Department of Rognidan , Division No 1 , Room no 1 tq. Walwa Dist. Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA 		 9588428904

dr.vaibhav.aayu7181@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Loknete Rajarambapu Patil Ayurved Mahavidyalaya Sangli Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vatari Guggul, Reference: Bhaishjyaratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: Nil
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient having the signs and symptoms of Amavata as per Ayurveda view like sandhishool (pain at joints), sandhishotha (swelling over joints), sandhi stabhdhata (stiffness over joints), tivra sparshasahatva (tenderness over joints)
upto 2 year.
2. The patients of Age group 20 to 60 years will be selected.
3. The patients will be selected irrespective of sex, religion. 
 
ExclusionCriteria 
Details  1. the patient of age less than 20yr and greater than 60yr.
2. pregnancy, lactating mother.
3. known case of syphilitis arthritis, Systemic Lupus Erythematosus, psoriatic arthritis 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the effect of vatari guggul on Amavata (Rheumatoid Arthritis) with special reference to C- reactive protein   30 days 
 
Secondary Outcome  
Outcome  TimePoints 
1) To study Amavata according to Ayurvedic literature.
2) To study Rheumatoid Arthritis.
3) To study C-Reactive Protein.
4) To study changes in Symptoms of Amavata
5) To study changes in C-Reactive Protein in Amavata by using Vatari
Guggul 		 30 days 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   11/08/2025 
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="6"
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         Amavata as a ‘Madhyam-marg Vyadhi’, where vyadhi take Ashraya of Aam. Aam is consider as major causative factor of many diseases in today’s global world. Amavata is also one of the diseases caused due to Aam. In contemporary lifestyles, various factors contribute to the accumulation of Aamsanchaya (accumulation of toxins), Aamdushti (vitiation of toxins), and Rasadushti (vitiation of bodily tissues), ultimately leading to Amavata. 
       Treatment for Amavata primarily involves Shodhan (purification) or Shaman (palliative) therapy. While Shodhan therapy is effective, it can be challenging to administer and time-consuming in daily life. On the other hand, Shaman therapy is less time-consuming, easily manageable, and cost-effective. Given these factors, Vatari Guggul is selected as a Shaman Aushadhi (palliative medicine) in this research.
          Vatari Guggul contains ingredients with diverse therapeutic properties, including Agnideepak (digestive stimulant), Aampachak (digestive), Vedana Sthapak (pain-relieving), Shothaghna (anti-inflammatory), Anulomak (promotes normal movement of Vata), Ruchikar (appetite stimulant), Balyakar (strength promoting), and possesses anti-inflammatory, anti-oxidant, anti- rheumatic, anti-pyretic, immune-boosting, and analgesic properties.
        C-Reactive Protein (CRP) serves as a valuable marker for inflammation in Amavata (Rheumatoid Arthritis), with its levels increasing notably during acute conditions and episodes of inflammation.
          Vatari Guggul will be observed for any changes in the signs and symptoms of Amavata, along with monitoring CRP levels. This approach aims to evaluate the therapeutic efficacy of Vatari Guggul in managing Amavata. By assessing both the clinical manifestations of the disease and the biochemical marker CRP, researchers can gain insights into the effectiveness of Vatari Guggul as a treatment for Amavata.
 
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