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CTRI Number  CTRI/2023/03/050758 [Registered on: 16/03/2023] Trial Registered Prospectively
Last Modified On: 12/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy and safety of G-Amrita formulation in the management of high uric acid and gouty arthritis 
Scientific Title of Study   Efficacy and safety of G-Amrita formulation in the management of high uric acid and gouty arthritis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Debasish Hota 
Designation  Professor & Head 
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of Pharmacology All India Institute of Medical Sciences Sijua Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  pharm_debasish@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Debasish Hota 
Designation  Professor & Head 
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of Pharmacology All India Institute of Medical Sciences Sijua Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  pharm_debasish@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query
 
Name  Debasish Hota 
Designation  Professor & Head 
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of Pharmacology All India Institute of Medical Sciences Sijua Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  pharm_debasish@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
Shree Dhanwantri Herbals 
 
Primary Sponsor  
Name  Shree Dhanwantri Herbals 
Address  Amritsar, Punjab, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Kumar Shukla  Department of Pharmacology  All India Institute of Medical Sciences, Bhopal
Bhopal
MADHYA PRADESH 
09755526266

ajay.pharm@aiimsbhopal.edu.in 
Prof Debasish Hota  Department of Pharmacology  All India Institute of Medical Sciences, Bhubaneswar
Khordha
ORISSA 
9438884190

pharm_debasish@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, Bhubaneswar  Approved 
Institutional Human Ethics Committee, AIIMS Bhopal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: G-AMRITA, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 800(mg), Frequency: tds, Bhaishajya Kal: Samudga, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: -
2Comparator Arm (Non Ayurveda)-Allopurinol100 mg OD
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  With the data of serum uric acid level more than 8.0 mg/dl  
 
ExclusionCriteria 
Details  1. Significant liver or Renal dysfunction, Hematological disease, Oncological disease, or other life threatens disorders.
2. Condition that need the management of diuretics or analgesics agent
3. Severe cerebrovascular disease or severe heart disease;
4. Mental diseases such as schizophrenia, depressive disorder, and drug dependence
5. Alcohol abuse or dependence
6. Aspartate aminotransferase (GOT) or alanine aminotransferase (GPT) level 2 times higher than the normal upper limit;
7. Creatinine higher than 2 mg/dl
8. Pregnant, lactating, or planning to become pregnant within 3 months; 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• The change in serum mean uric acid after 8 weeks of therapy when compared to baseline   0, 4 weeks, 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in VAS score
 
0, 4 weeks, 8 weeks 
Change in liver & renal function parameters in blood

 
0, 4 weeks, 8 weeks 
Changes in hemogram (Hb, TLC, DLC)  0, 4 weeks, 8 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   20/03/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Many plant extracts and herbs have been used in the treatment and management  of Gout and hyperuricemia since long. Out of these plants, Tinospora cordifolia, Terminalia Chebula, Embica officinalis, Terminalia Bellirica and Tribulus terresteris have been chosen to form formulation for Gout and Hyper uricemia. These contains compounds with anti-prolferative, anti-oxidant, anti-inflammatory activities and is known to help in the management of Gout treatment. Tinospora cordifolia is immensely useful due to the presence of different compounds of pharmaceutical significance belonging to various groups such as alkaloids, diterpenoid lactones, glycosides, steroids, sesquiterpenoids, and phenolics. These compounds possess pharmacological properties, which make it anti-diabetic, antipyretic, antiinflammatory, anti-oxidant, hepato-protective, and immuno-modulatory [6].  T. chebula is supposed to have a significant quantity of gallic acid, ellagic acid, tannic acid, β-sitosterol, ethyl gallate, chebulic acid, ascorbic acid, and mannitol, which are responsible for its various pharmacological properties. In one study, it was seen that in addition to possessing superoxide radical scavenging activity (7]. T. bellerica  also inhibited uric acid formation, which was indicative of its XO enzyme inhibitory activity. Tribulus terrestris is a natural herb, also known as Puncture vine or Gokhru, used for treating several diseases and found in many tropical and moderate areas of the world, including the US and Mexico, Mediterranean region, and throughout Asia. T. terrestris is aphrodisiac, antihypertensive, diuretic, and antiurolithiatic in nature T. terrestris significantly reduced the excretion of oxalate, calcium, and phosphate along with decreased levels of blood urea nitrogen, uric acid and creatinine in serum. T. terrestris also reduced hyperoxaluria- caused oxidative stress, and restored antioxidant enzyme activity and their expression profile in kidney tissue. Emblica possess a vast ethno medical history and represents a phytochemical reservoir of heuristic medicinal value. It has been suggested in the scientific literature that consumption of it alleviates arthritic pain and Gout. Many pharmacological studies have shown that this plant extracts having antioxidant, anticarcinogenic, antitumor, antigenotoxic, antigout, and anti-inflammatory activities, and supporting its traditional uses. 

Keeping such benefits in view, it was aimed to study effectiveness and safety profile of G -AMRITA in patients with hyper uricemia and /or Gout 
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