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CTRI Number  CTRI/2024/09/073473 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 04/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to compare the effectiveness of Navakarshika kwatham and Trinapanchamoola kwatham in Hyperuricemia. 
Scientific Title of Study   A comparative study to evaluate the effectiveness of aqueous extracts of Navakarshika kwatham and Trinapanchamoola kwatham in Hyperuricemia. 
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 Neenu Saji 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College, Thiruvananthapuram. 
Address  Department of Kayachikitsa, OP No.2,Room No. 2, Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram, kerala,695001
Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram, kerala,695001
Thiruvananthapuram
KERALA
695001
India 
Phone  9744630266  
Fax    
Email  neenuthakidiyil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neenu Saji 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College, Thiruvananthapuram. 
Address  Department of Kayachikitsa,OP No.2,Room No.2,Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram, kerala,695001
Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram, kerala,695001
Thiruvananthapuram
KERALA
695001
India 
Phone  9744630266  
Fax    
Email  neenuthakidiyil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suneeshmon M S 
Designation  Assistant Professor 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  Department of Kayachikitsa,OP No.2,Room No.2,Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala

Thiruvananthapuram
KERALA
695001
India 
Phone  9846009359  
Fax    
Email  drsuneeshmonkc@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital,Pulimoodu junction, Thiruvananthapuram,Kerala,695001, India 
 
Primary Sponsor  
Name  Dr Neenu Saji 
Address  PG Scholar, Government Ayurveda Medical College and Hospital, Pulimoodu junction,Thiruvananthapuram, Kerala, 695001 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 Neenu Saji  Government Ayurveda Medical College and Hospital.  Department of Kayachikitsa,O.P No.2,Government Ayurveda Medical College and Hospital,Thiruvananthapuram, 695001
Idukki
KERALA 		 9744630266

neenuthakidiyil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) Govt. Ayurveda College, Thiruvananthapuram, Kerala,India.   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: VATARAKTA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Trinapanchamoola kwatham, Reference: Sahasrayogam,Mutrakrichra, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Navakarshika Kwatham, Reference: Chakradutta,vataraktha chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
3Intervention ArmDrugClassical(1) Medicine Name: Navakarshika kwatham, Reference: chakradutta ,vataraktha chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
4Comparator ArmDrugClassical(1) Medicine Name: Trina panchamoola kwatham, Reference: Sahasrayogam,Mutrakrichra chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Males and females of age group 30 to 60 years having Serum Uricacid level above 6.8mg/dL and 5.7 mg/dL respectively. 
 
ExclusionCriteria 
Details  1. Pregnancy and lactation.
2. Participants on medication for coronary artery disease,cerebrovascular accidents,any type of neoplastic diseases.
3. Participants taking corticosteroids, antidepressants or diuretics.
4.Participants taking anti tubercular drugs.
5. Diagnosed cases of medical renal diseases. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Estimation of changes in Serum Uricacid level.  0th day and 31st day 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   17/09/2024 
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 - NO
Brief Summary  
Uric acid is the final byproduct of purine metabolism , which is produced by xanthine oxidase".
Elevated levels of serum uric acid are a hall mark of hyperuricemia’. Hyperuricemia is defined as a plasma(or serum) urate concentration > 405 M mol/L (6.8 mg/dL)’. According to estimates, hyperuricemia affects up to 21% of the general population and 25% of hospitalized patients’ .
Hyperuricemia related conditions mainly include gout. Hyperuricemia causes endothelial dysfunction by causing an increase in inflammation and oxidative stress which is associated with dyslipidemia,diabetes mellitus,hypertension and menopause.
Hyperuricemia results due to uric acid metabolism impairment and can be correlated to pitta pradhana dosha dushti ,which is rasa-raktha dhatu asritha and is brought on by rasa-raktha dhatwagni mandyam. Present study will be conducted to compare the effectiveness of Navakarshika kwatham given as aqueous extract mentioned in Chakradutta Vataraktha chikitsa’ and Trinapanchamoola kwatham given as aqueous extract mentioned in Sahasrayogam Mutrakrichra chikitsa’ in hyperuricemia.A comparative study will be conducted in consecutive cases attending OPD of Kayachikitsa,Govt Ayurveda college;Thiruvananthapuram having hyperuricemia and are divided into 2 groups;each having 22 participants of age group 30-60 years. Group A will be intervened by Navakarshika kwatham  and Group B with Trinapanchamoola kwatham . Drugs administered for 30 days and serum uric acid level will be estimated for clinical evaluation both before and after the intervention.
 
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