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CTRI Number  CTRI/2017/04/008397 [Registered on: 24/04/2017] Trial Registered Retrospectively
Last Modified On: 23/04/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   OBSERVATIONAL STUDY OF NIDANA PANCHAKA OF AMAVATA WITH SPECIAL REFERENCE TO RHEUMATOID ARTHRITIS 
Scientific Title of Study   OBSERVATIONAL STUDY OF NIDANA PANCHAKA OF AMAVATA WITH SPECIAL REFERENCE TO RHEUMATOID ARTHRITIS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  B Arun Prakash 
Designation  PG scholar 
Affiliation  Parul Institute Of Ayurveda, Parul University 
Address  Department of Roga Vignana evum vikruti vignana, Parul Institute Of Ayurveda, Parul University, Limda Parul University, Limda Vadodara, GUJARAT,391760, India.

Vadodara
GUJARAT
391760
India 
Phone  9944348235  
Fax    
Email  arundoctorarun@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Harish soni 
Designation  Professor 
Affiliation  Parul Institute Of Ayurveda, Parul University 
Address  Department of kaya chikitsa, Parul Institute Of Ayurveda, Parul University, Limda Parul University, Limda Vadodara, GUJARAT,391760, India.

Vadodara
GUJARAT
391760
India 
Phone  7878374848  
Fax    
Email  haresh.soni@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Harish soni 
Designation  Professor 
Affiliation  Parul Institute Of Ayurveda, Parul University 
Address  Department of kaya chikitsa, Parul Institute Of Ayurveda, Parul University, Limda Parul University, Limda Vadodara, GUJARAT,391760, India.

Vadodara
GUJARAT
391760
India 
Phone  7878374848  
Fax    
Email  haresh.soni@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Parul Institute Of Ayurveda 
 
Primary Sponsor  
Name  Parul institute of Ayurveda and Hospital 
Address  Parul University, Limda,Vadodara 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NILL  NILL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
BArun Prakash  Parul Institute Of Ayurveda  Parul Institute Of Ayurveda, Panchakarma op no 113 Kaya chikitsa 106 Parul University, Limda Vadodara, GUJARAT,391760, India.
Vadodara
GUJARAT 
9944348235

arundoctorarun@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institunal ethical comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  RHEUMATOID ARTHRITIS,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient with classical signs and symptoms of amavata as per ayurveda will be selected.
Patients of age group between 25 to 60 years.
Patients will be selected irrespective of their gender and religion.
Patients will be selected both seropositive and seronegative.
 
 
ExclusionCriteria 
Details  Patients of age group > 60 and < 25 years.
Patients with any other major illnesses e.g. osteoporosis, osteoarthritis, gouty arthritis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To find out the cause of the disease  one day 
 
Secondary Outcome  
Outcome  TimePoints 
Angamardha (Body Ache)
Aruchi (Loss Of Taste)
Trishna (Thirst)
Alasya (Laziness)
Gaurava (Heaviness)
Jvara (Fever)
Apaka (Indigestion)
Shoonata Anganam(Numbness)
Stabdata (Stiffness)
 
one day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   02/03/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT YET DONE 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

HYPOTHESIS: There is a relation between nidana panchaka of amavata and rheumatoid arthritis



Rheumatoid arthritis affects 15% people i.e over 180 million people in India. This prevalence is higher than many well known diseases such as diabetes, cancer and AIDS. It can affect many facets of a patient’s life, viz. his family, occupational and community relationships even. It affects not only the social and economic position of the individual and his family but it leads to the draining of national resource due to the work hours lost, resulting in diminished production. Rheumatoid arthritis is the second most common type of arthritis, 70 percent of the patients who have the disease is woman. Rheumatoid arthritis usually develops between the age of 30 and 50 but it can occur at any age. In present era, enormous changes are noted in life style, food habits, working pattern, sleep pattern, stress level etc. These all factors are becoming common causative factors of so many diseases. Also, new food article are added in routine life of so many individuals, so new etiological factors are always at increasing part. These newly added etiological factors are to be identified and have to be added as extra etiological factors of respective disease because of every person indulging in improper food (Viruddhahara) and activities causes provocation of Vata dosha and Agni dusti, by these prime factors a primordial disease manifesting factor developed known as amavata


Here we will study the nidan panchak of aamavata with special reference to rheumatoid arthritis. This will definitely shed light on nidan panchak of amavata specially hetu which are found now a days. This will help in treatment.




 
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