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CTRI Number  CTRI/2024/06/069098 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 17/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Curative]  
Study Design  Single Arm Study 
Public Title of Study   Effect of Ayurveda Formulation in Hyperuricemia 
Scientific Title of Study   Combined effect of Amritaguggulu and Amritashadangam Kashayam in the management of Hyperuricemia a pre test post test design 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SILPA M R  
Designation  PG Scholar 
Affiliation  Vaidyaratnam Ayurveda College Ollur 
Address  Department of Kayachikitsa Vaidyaratnam Ayurveda College Ollur Thrissur
Department of Kayachikitsa Vaidyaratnam Ayurveda College Ollur Thrissur
Thrissur
KERALA
680306
India 
Phone  9995478572  
Fax    
Email  silpaachanjal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr PV GIRI 
Designation  Professor Department of Kayachikitsa  
Affiliation  Vaidyaratnam Ayurveda College, Ollur 
Address  Department of Kayachikitsa Vaidyaratnam Ayurveda College Thaikkattussery Ollur Thrissur

Thrissur
KERALA
680306
India 
Phone  9447527366  
Fax    
Email  doctorviswagiri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr PV GIRI 
Designation  Professor Department of Kayachikitsa 
Affiliation  Vaidyaratnam Ayurveda College, Ollur 
Address  Department of Kayachikitsa Vaidyaratnam Ayurveda College Thaikkattussery Ollur Thrissur

Thrissur
KERALA
680306
India 
Phone  9447527366  
Fax    
Email  doctorviswagiri@gmail.com  
 
Source of Monetary or Material Support  
Vaidyaratnam Ayurveda College Ollur Thrissur 680306 pin Kerala India 
 
Primary Sponsor  
Name  SILPA M R 
Address  Vaidyaratnam Ayurveda College Thaikkattussery Ollur Thrissur Kerala 680306 Pin India 
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 SILPA MR  Vaidyaratnam Ayurveda College Ollur  OPD Department of Kayachikitsa Vaidyaratnam Ayurveda College Ollur Thrissur 680306 Pin
Thrissur
KERALA 
9995478572

silpaachanjal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Vaidyaratnam Ayurveda College Ollur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E790||Hyperuricemia without signs of inflammatory arthritis and tophaceous disease. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Amrita Guggulu, Reference: Chakradatta, Route: Oral, Dosage Form: Guggulu , Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -Given with Amritashadangam Kashayam
(2) Medicine Name: Amritashadangam Kashayam, Reference: Chikitsamanjari, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 45(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Participants without symptoms and with symptoms like pain and or tenderness of joint and
serum uric acid level greater than 6.8mg/dL to 12mg/dl in males and greater than 5.7mg/dL to 12mg/dl in females
will be included
2.Participants aged between 30-60 years will be included
 
 
ExclusionCriteria 
Details  1.Participants with secondary Gout, pre diagnosed cases of Rheumatoid Arthritis.
2.Participants taking other medication for hyperuricemia.
3.Severe Systemic illness such as Chronic Kidney Disease, Diabetes Mellitus.
4.Chronic Cardiac Disease.
5.Pregnant women and lactating mother.
6.Participants having completed any other trial with in past 6 months.
7.Participants intaking alcohol 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Serum Uric acid  Before After and Follow up 0th, 31st, 45th 
 
Secondary Outcome  
Outcome  TimePoints 
Subjective Parameters Tenderness Pain Ama  Before after & on Follow up 0th, 31st, 45th 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
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/ Phase 3 
Date of First Enrollment (India)   01/07/2024 
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="6"
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 - 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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included www.hyperuricemia.in).

  6. For how long will this data be available start date provided 01-04-2026 and end date provided 01-04-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

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

Hyperuricemia is defined as a serum urate concentration of >6.8mg /dl for men and >5.7mg/dl for women. Worldwide, the prevalence of hyperuricemia has increased substantially in recent decades. The most well-known disease induced by hyperuricemia is gout. However, many studies have reported that hyperuricemia also plays an important role in cardiac-kidney vascular system disease and metabolic syndrome. Hence, by defining the gravity of the condition based on the existing facts, the condition requires proper understanding followed by a strong and rational approach. The symptoms of Hyperuricemia and Gouty arthritis are similar to vatharakta, a disease explained in classical Ayurvedic textbooks. Since it is an outcome of impaired uric acid metabolism, A drug having agnideepana, amapachana, pithahara and raktaprasadana property is effective in this clinical condition. The study drug Amrita Guggulu described in Chakradatta Vatarakta chikitsa, Amritashadangam kashayam described in Chikitsamanjari Vatarakta chikitsa are widely used by Ayurvedic practitioners of kerala for treating hyperuricemia and its complications.Since the condition is having high prevalence even now, it is need of the hour to have a safe and effective treatment for the condition.Since prevention is better than cure, managing modifiable risk factors plays a key role in medical practice. Even though the incidence and prevalence of Gouty arthritis, Uric acid nephrolithiasis and Acute Uric acid nephropathies are increasing in the past two decades, the management of the risk factor is still unsatisfactory in terms of the community- wide lack of knowledge about the risk factor, availability of a cost effective and effective medicament.

 
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