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CTRI Number  CTRI/2020/05/025355 [Registered on: 26/05/2020] Trial Registered Prospectively
Last Modified On: 22/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effect of patoladi kwath and hapushadi yapan vasti in vatarakta(gouty arthritis) 
Scientific Title of Study   A comparative study of patoladi kwath and hapushadi yapan vasti in vatarakta  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dinesh Kumar Goyal 
Designation  Professor & H.O.D 
Affiliation  uttarakhand ayurveda university 
Address  Gurukul campus, Uttarakhand Ayurveda University, Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  9411731180  
Fax    
Email  dineshdr157@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh Kumar Goyal 
Designation  Professor & H.O.D  
Affiliation  Gurukul campus, uttarakhand ayurveda university 
Address  Gurukul campus, Uttarakhand Ayurveda University, Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  9411731180  
Fax    
Email  dineshdr157@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dinesh Kumar Goyal 
Designation  Professor & H.O.D  
Affiliation  uttarakhand ayurveda university 
Address  Gurukul campus, Uttarakhand Ayurveda University, Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  9411731180  
Fax    
Email  dineshdr157@gmail.com  
 
Source of Monetary or Material Support  
Gurukul campus, uttarakhand ayurveda university,haridwar 
 
Primary Sponsor  
Name  tanushree 
Address  gurukul campus,UAU,haridwar 
Type of Sponsor  Other [self sponsored] 
 
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 
tanushree  gurukul campus U.A.U.  room number-5,kayachikitsa department, gurukul hospital
Hardwar
UTTARANCHAL 		 7417378067

tanushree.jhingrun@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M10||Gout,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  group A(Patoladi kwath)  20 patients will be treated with patoladi kwath(patola, katuki, shatavari, haritaki, vibhitaki, amalaki,giloy) freshly prepared twice a day and administered in a dose of 40 m.l. orally regularly for 45 days. Assessment will be done every 15 days for one month after completion of treatment. 
Comparator Agent  group B(Hapushadi yapan vasti)  20 patients will be treated with hapushadi yapan vasti( hapusha and yava kwath mixed with cow milk, cow ghee, honey, saindhav lavan) in a dose of 600 m.l. daily per rectally given for 7 days in one cycle. Another cycle of vasti for 7 days will be given to the patient with a gap of 7 days, therefore a total of one month treatment period of vasti will be administered. Assessment will be done after completion of every cycle and follow up will be done every 15 days for one month after completion of treatment. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Well diagnosed patients of Vatarakta. (Diagnosis will be made on the basis of assessment criteria as mentioned in classical texts & modern medical science.)
Both previously treated and fresh cases will be taken.
Patients of either sex.
Increased serum uric acid levels of more than 7mg/dl in males and 6mg/dl in females.

 
 
ExclusionCriteria 
Details  Patients of Vatarakta with any chronic systemic disorder which interferes with the present study.
Patients of age below 18 or more than 70 years.
Patients of Vatarakta having any severe arthritic condition (like R.A.) will be excluded .
Patients of Vatarakta with conditions like haemarthrosis, Koch’s arthritis, septic arthritis, chronic kidney disease.
Patients with serious medical illness and psychiatric disorder will be excluded.
Cases with alcohol dependence/ misuse and drug abuse.
Pregnancy.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduction in subjective parameters according to the specific grading given to each symptoms like burning, pain, skin discoloration, redness, stiffness, tenderness, numbness, heaviness, swelling, deformity in joint involved and pain on joint movement.
no sign-0
mild-1
moderate-2
severe-3
Also reduction in objective parameters of serum uric acid.  		 the patient will be followed up at every 15 days for one month after completion of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
reduction in erythrocyte sedimentation rate.
exacerbation of symptoms. 		 the patient will be followed up at every 15 days after completion of treatment. 
 
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 2 
Date of First Enrollment (India)   28/05/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   A total of 40 patients of vatarakta will be selected from opd and ipd of pg department of kayachikitsa uau, gurukul campus, haridwar. The study will be conducted on the patients randomly divided into 2 groups that is 20 patients in each group on the basis of inclusion and exclusion criteria depending on detailed clinical history, physical examination and other necessary and desired investigation. The patients will be followed up at every 15 days after completion of trial.  
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