| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Drug | Classical | | (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. |