FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077404 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study Of Navakarshik Kwath And Navakarshik Ghanvati in The Management Of Gout. 
Scientific Title of Study   A Clinico-Comparative Study Of Navakarshik Kwath And Navakarshik Ghanvati in The Management Of Vatarakta W.S.R. to Gout 
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 Shalik Ram Verma 
Designation  PG Scholar 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 
Address  Kayachikitsa Department, Shri Narayan Prasad Awasthi Government Ayurved College & Hospital Raipur Chhattisgarh OPD no. 2 & 18

Raipur
CHHATTISGARH
492010
India 
Phone  9827898685  
Fax    
Email  shalikverma1980@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pramod Kumar Baghel 
Designation  Assistant Professor 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 
Address  Kayachikitsa Department, Shri Narayan Prasad Awasthi Government Ayurved College & Hospital Raipur Chhattisgarh OPD no. 2 & 18

Raipur
CHHATTISGARH
492010
India 
Phone  7354450821  
Fax    
Email  dr.pkbaghel08@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shalik Ram Verma 
Designation  PG Scholar 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 
Address  Kayachikitsa Department, Shri Narayan Prasad Awasthi Government Ayurved College & Hospital Raipur Chhattisgarh OPD no. 2 & 18


CHHATTISGARH
492010
India 
Phone  9827898685  
Fax    
Email  shalikverma1980@gmail.com  
 
Source of Monetary or Material Support  
Kayachikitsa Department Shri Khudadad Dungaji Government Ayurved Hospital Raipur Chhattisgarh OPD no 2 and 18  
 
Primary Sponsor  
Name  Office of Principal Shri NPA Government Ayurveda College Raipur Chhattisgarh 
Address  Kayachikitsa Department Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 
Type of Sponsor  Government medical college 
 
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 Shalik Ram Verma  Shri Khudadad Dungaji Ayurveda Hospital Raipur Chhattisgarh  OPD No 2 and 18 Male and Female IPD of Kayachikitsa Department Shri Khudadad Dungaji Ayurveda Hospital Raipur Chhattisgarh
Raipur
CHHATTISGARH 
9827898685

shalikverma1980@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Principal Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh  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 ArmDrugClassical(1) Medicine Name: Navakarshik kwath, Reference: Vangasen samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Navakarshik Ghanvati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Vatarakta Patients Based on Symptoms Described in Ayurveda Samhita and Modern Textbook 
 
ExclusionCriteria 
Details  Chronic Disease Conditions like Diabetes, Renal Failure
Antenatal Care
Septic in Joints
Skin Sensitivity
Who Disagree with the Trial  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Observe the Effect of Navakarshik Kwath and Navakarshik Ghanvati in the Management of Vatarakta W.S.R. to Gout  60 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To Study any Adverse Effect of Navakarshik Kwath and Navakarshik Ghanvati in the Management of Vatarakta W.S.R. to Gout  60 Days 
 
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)   01/04/2025 
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)   Not Yet Recruiting 
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  

INTRODUCTION -

In Ayurveda Samhita texts, we find a detailed classification of disease in which 80 types of Vataj diseases, 40 types of Pittaj and 20 types of Kaphaj disease are classified. Although it is not possible to name all the disease, yet treatment shoild be done after studying the Dosha and diagnosis.

Origin of Vatavyadhi -

There are two main reason for Vata Prakop - 1. Dhatukshaya janya    2. Marga awarodh janya

The origin of Vatarakta said to be due to Rheumatism in the joint due to Dhatukshaya and Margawarodh of Rakta due to Avaran of Vayu .

Nidan of Vatarakta - 

Generally, men with delicate nature (Sukumar Vyakti) and Mithya ahar vihar, living habit and those who are prone to grief, and those who indulge in sexual intercourse, drinking alcohol and excessive exercise, those who have food and living contrary to the season and harmony, and those who use wrong kind of affection and those who are obese, affected by Gout.

 

Need of the Study – Gout is a metabolic disorder that occurs in middle age and small joint. That is due to reasons that contaminate the blood and by consuming food and lifestyle that increases vata, the air passage is blocked by vayu and contaminated blood. The disorder that arises in such a condition should be considered as vatrakta or vata shonit.

According to modern opinion, gout is a disease that occurs as a result of abnormal metabolism of protein in which crystal of uric acid (Monosodium urate Monohydrate) are produced in our body. Due to which the level of uric acid in the blood becomes higher than normal. This disease is usually found more in men.

According to a research 0.58 to 2.89 % of the world’s total population is found to be affected by Gout. In Asian countries the prevalence of Gout is about 25.8per 1000 people and level of uric acid is found to be higher than normal.

In modern medical science, the side effects of the medicines used for the treatment of gout are seen, which mainly include skin deformity, convulsion and excessive thirst. Due to the use of these medicines, symptoms of loss of strength are especially reflected in the patients.

Hence the use of Ayurvedic medicines for easy, accessible and safe treatment of gout cannot be denied, however there is a need for extensive research in gout disease.

Hence for my dissertation, I have chosen the subject of experimental study of Navakarshik kwath described in vangasen samhita for the treatment of gout. In which, according to the drug concept  and methods of intake, I have chosen the subject of comparative medical study of the kwath and ghanvati form of the used drug. So that gout patients can be treated effectively and safely.

 

Type of study- Prospective, Interventional, Open level, Single arm, Non-Randomized, Comparative clinical study        
Close