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CTRI Number  CTRI/2021/04/032944 [Registered on: 19/04/2021] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   to study the efficacy between Aatarushadi Kwath Ghana Vati and Kaishore Guggul in treatment of Gout (Vatarakta) 
Scientific Title of Study   A Randomized controlled clinical trial to evaluate the efficacy between Aatarushadi Kwath Ghana Vati and Kaishore Guggul in the management of Vatarakta. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajat Rajender Bansal 
Designation  PG Scholar 
Affiliation  PDEAS College of Ayurved and research center pradhikaran nigdi pune 
Address  PDEAS college of Ayurveda and research center,third floor, kayachikitsa department, sector no 25, pradhikaran nigdi , pune

Pune
MAHARASHTRA
411044
India 
Phone  8529268414  
Fax    
Email  dr.rajatbansal2012@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Medha Mahesh Joshi 
Designation  H.O.D of Kayachikitsa Department 
Affiliation  PDEAS college of ayurved and research center pradhikaran nigdi pune 
Address  PDEAS college of Ayurveda and research center,third floor, kayachikitsa department, sector no 25, pradhikaran nigdi , pune

Pune
MAHARASHTRA
411044
India 
Phone  9881465798  
Fax    
Email  medhamaheshjoshi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajat Rajender Bansal 
Designation  PG scholar 
Affiliation  PDEAS college of Ayurved and research center pradhikaran nigdi pune 
Address  PDEAS college of Ayurveda and research center,third floor, kayachikitsa department, sector no 25, pradhikaran nigdi , pune

Pune
MAHARASHTRA
411044
India 
Phone  08529268414  
Fax    
Email  dr.rajatbansal2012@gmail.com  
 
Source of Monetary or Material Support  
PDEAS College of Ayurved and Research center, Sector no 25, Pradhikaran Nigdi, Pune 
 
Primary Sponsor  
Name  PDEAS College of Ayurved and Research Center Pradhikaran Nigdi Pune 
Address  PDEAS College of Ayurved and Research center, Sector 25, Pradhikaran Nigdi Pune 411044 
Type of Sponsor  Private 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 Rajat Rajender Bansal  PDEAS Ayurved Ruganalya and Sterling Multispeciality Hospital Nigdi Pradhikaran Pune  Vitthal Rukmini Road sector no 27, Kayachikitsa OPD no 117, Ground floor, Nigdi Pradhikaran Pune Maharashtra
Pune
MAHARASHTRA 
08529268414

dr.rajatbansal2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aatarushadi Kwath Ghan Vati   Group A will be Treated with Aatarushadi Kwath Ghan Vati containing Aatarush ,amrita ,erand, Avalguja and haritaki. Aatarushadi Kwath Ghan Vati will be given orally in the dose of 500mg two times a day after meal with lukewarm water in the age group of 20-65 years which includes follow up on 15th , 30th ,45th day 
Comparator Agent  kaishore Guggul  Group B will be Treated with kaishore Guggul containing Guduchi,Amalaki, Bibhitaki, Haritaki, Guggul,Shunthi,Marich,pipali, Vidanga,trivrit,Danti. kaishore Guggul will be given orally in the dose of 500mg two times a day after meal with lukewarm water in the age group of 20-65 years which includes follow up on 15th , 30th ,45th day 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients having clinical signs and symptoms of Vatrakta such as Sandhi shula/Toda (Pain), Sandhi Shotha (swelling), Sparshaashatva (Tenderness), Chimichimayan (tingling sensation),team vaivarnya (Discoloration Of skin).
Age group having 20 to 65 years irrespective of religion, gender, socioeconomic status.
Patient having serum uric acid more than 7 mg/dl in male and more than 6mg/dl in female.  
 
ExclusionCriteria 
Details  Known case of Amavata, Sandhigata vata, SLE, Renal Disease
Known case of tuberculosis of any system
Chronic joint deformity
Hypersensitive reaction to any drug
Pregnancy
Patients with chronic major illness

High risk (above 65 yrs age,known cases of HTN,DM,COPD),Comorbid patients Suspected for Covid-19. Suspected Covid-19
patients having symptoms as per ICMR guidelines. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Aatarushadi Kwath Ghan Vati 500mg two times a day after meal with lukewarm water and Kaishore Guggul 500mg two times a day after meal with lukewarm water in the management of Vatarakta (Gout) with reference to increase Serum uric acid level within 45 days   45 days with follow up on 15th , 30th , 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare and study the efficacy of Aatarushadi Kwath Ghan Vati
2. To compare and study the efficacy of Kaishore Guggul
3.To study the adverse effects if any  
45 days with follow up on 15th , 30th , 45th day 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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   N/A 
Date of First Enrollment (India)   26/04/2021 
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   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Ayurveda is the science of life. It believes that health and wellbeing
depends on a balance between the three Doshas - Vata, Pitta, and Kapha
which are the physiologic basis of human body, when there is imbalance in
these three doshas than these causes illness.
Vatarakta is one such disease. It was first described as an independent
disease in Charak Samhita. It is a disease of Madhyam Roga Marga as it
affects mainly Sandhis.
In Ayurveda, Vatarakta is said to be caused by adhyashana, virudhasana
(which can be correlated with faulty and irregular dietary habits), krodh
(mental stress), divaswapna and prajagarana (irregular sleep habits),
misthansukhbhojinam, achankramanshila (sedentary life style) etc.
due
to these Nidanas Vata and Rakta gets vitiated. Aggravated Vata is blocked
by vitiated Rakta which in turn leads to further aggravation of Vata. This
aggravated Vata again causes vitiation of whole Rakta. these vitiated Vata
along with deranged Rakta circulates very fast all over the body due to the
Sukshma (Minuteness) and Drava (Liquid state) Guna (characters) of Vata
and Rakta respectively and undergo Dosha-Dushya Sammurchana
(Pathogenesis) in Sandhi sthana (Joints), specifically Kar, Pada and Angula
sandhi (Metacarpo and Metatarso-phalangeal joint).
The characteristics of Vatarakta resemble with those of Gout therefore it
can better be correlated with Gouty arthritis in modern medical science.
Gout is the disease of middle aged group in which an abnormality of Uric
acid metabolism that causes Hyperuricemia and deposition of Mono-
sodium urate crystal in joints causes Acute Gouty Arthritis, in soft tissue
causing tophi and tenosynovitis, in renal tubules causing urate stones and
urate nephropathy.
The general prevalence of gout is 1–4% of the general population. It occurs
in men 2–6 folds more than women. Worldwide incidence of gout
increases gradually due to poor dietary habits such as fast foods, lack of
exercises, increased incidence of obesity and metabolic syndrome.
Conventional drugs used in the management of gout like NSAIDS,
glucocorticoids, xanthine oxidase inhibitors and uricosuric drugs; have
potential side effects and a possibility of drug interaction with other
prescribed drug which restricts their use; because in modern medical
science, its management aspect still remains symptomatic with
troublesome side effects.
With these recurrence and short term benefits in modern system ofmedicine, Ayurveda can provide a very good holistic treatment option.
Today there is need to find the drug which gives long term relief without
any side effects, is easily available, no recurrence and easy to follow.
Bhaishajya Ratnawali has described the efficacy of Aatarushadi Kwath in
management of Vatarakta.
Aatarushadi kwath includes Aatarush (Vasa), Amrita (Guduchi), Erand ,
Avalguja (Bakuchi), Haritaki. Aatarush act as blood purifier.
 Amrita act as
tridoshshamak , rasayan , vedna sthapan. Erand has property of
kapha-vata shamak, shoth har, used in rakta vikar. Avalguja has balya
effect on nervous system, shoth nashak and promotes rakta samvahan.
Haritaki has property of rasayan, shonit sthapan, mutral & shoth har.
These five drugs show antagonistic action on prakupit Vata doshas and
Rakta dhatu involved in Vatarakta.
In previous study Kaishore Guggul was found to be significant in the
management of Vatarakta therefore for the present study Kaishore
Guggul will be taken as a control group.
 
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