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CTRI Number  CTRI/2026/01/101722 [Registered on: 21/01/2026] Trial Registered Prospectively
Last Modified On: 21/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A research study to see how two ayurvedic medicines work for high uric acid levels 
Scientific Title of Study   A Randomized Clinical Trial to compare the effect of Kokilaksha Kashayam and Kokilakshadi Kashayam 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  Singh Satyam Sujit 
Designation  Pg Scholar 
Affiliation  Government Ayurveda College , Tripunithura 
Address  Department of Kayachikitsa, Government Ayurveda College, Tripunithura,Ernakulam ,Kerala.

Ernakulam
KERALA
682301
India 
Phone  7506695773  
Fax    
Email  drsatyamkayam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bindu P R 
Designation  Associate Professor 
Affiliation  Government Ayurveda College Tripunithura 
Address  Department Of Kayachikitsa, Government Ayurveda College, Pariyaram, Kannur.

Kannur
KERALA
670503
India 
Phone  7907112674  
Fax    
Email  drbindhuprasanth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bindu P R 
Designation  Associate Professor 
Affiliation  Government Ayurveda College Tripunithura 
Address  Department Of Kayachikitsa, Goverment Ayurveda College, Pariyaram, Kannur.

Kannur
KERALA
670503
India 
Phone  7907112674  
Fax    
Email  drbindhuprasanth@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College Tripunithura 
 
Primary Sponsor  
Name  Singh Satyam Sujit 
Address  Pg Scholar, Department Of Kayachikitsa, Government Ayurveda College Tripunithura, Ernakulam District Kerala 682301 
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 
Singh Satyam Sujit  Government Ayurveda College Tripunithura  Department Of Kayachikitsa,Ground Floor, Hospital Building, Government Ayurveda College Tripunithura Kerala 682301
Ernakulam
KERALA 
7506695773

drsatyamkayam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVT. AYURVEDA COLLEGE, TRIPUNITHURA  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: KOKILAKSHA KASHAYAM, Reference: ASHTANG HRIDYAM 22/18, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: KOKILAKSHADI KASHAYAM, Reference: CHAKRADATTA CHIKITSA 23/17 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -250MG PIPPALI CHURNA), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants with high serum uric acids levels of males with greater than 6.8mg/dl and females with greater than 5.7mg/dl up to 15 mg/dl.
Participants aged between 18-60 years will be included.
Participants giving informed consent. 
 
ExclusionCriteria 
Details  Participants presenting with acute gouty arthritis.
Uncontrolled systemic diseases.
Major systemic illness, on chronic medication, pregnant women, lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in Serum uric acid levels  Assessment was carried out at baseline day and after 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Using Visual Analogue Scale for Pain,Swelling ,Tenderness And Stiffness.  Assessment was carried out at baseline & after 4 weeks  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3 
Date of First Enrollment (India)   04/02/2026 
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  

Hyperuricemia is a metabolic disorder commonly seen in gout, caused by increased serum uric acid levels due to reduced renal excretion. It is defined as serum uric acid levels greater than 6.8 mg/dL in males and greater than 5.7 mg/dL in females. Risk factors include high intake of purine-rich foods, alcohol use, certain drugs, hypertension, hypothyroidism, and obesity.Uric acid is the final product of purine metabolism in humans. Purines are broken down mainly in the liver by xanthine oxidase, converting hypoxanthine to xanthine and then to uric acid. Uric acid circulates in plasma and is excreted mainly by the kidneys. When serum levels exceed about 7 mg/dL, monosodium urate crystals may form and deposit in joints, triggering inflammation with pain, swelling, tenderness, and stiffness.From an Ayurvedic perspective, hyperuricemia can be explained by Dhatvagni Mandya, leading to Ama Utpatti and Mala Sanchaya, resulting in Pitta Prakopa and Rakta Dushti. The vitiated Rakta produces Paittika lakshanas such as osha, chosha, paridaha, and dhumayana. The associated Avarana of Vata localizes at Asthi and Sandhi sites of khavaigunya, producing features resembling Pittadhika Vatarakta like ruk, raga, shotha, sparshasahatva, and sandhivikriti.Kokilakshadi Kashaya, described in Bhaishajya Ratnavali and Chakradatta under Vatarakta Chikitsa, contains Guduchi and Kokilaksha, with Pippali as anupana. Ashtanga Hridaya also mentions Kokilaksha as a single-drug formulation for Vatarakta. Guduchi has proven hypouricemic, anti-inflammatory, anti-arthritic and immunomodulatory actions, supporting its classical indication.

 
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